Patient & Survivor Care

The first time Dave Fuehrer was diagnosed with testicular cancer, he was knocked back. The twenty-something competitive bodybuilder, a recent New York State champion, was unprepared for his journey from wellness to disease, and then through treatments and their sequelae.

However, it was the second diagnosis of primary testicular cancer that really got to him, he said. This time, he was a recently married young professional who was working on starting a family. The second round of cancer took parenthood away from him and left him “feeling even more lost and ashamed” than the first diagnosis, he said in an interview. He felt isolated, alone, and very different from most of the other cancer patients he saw.

Now, Mr. Fuehrer and partners, all of whom have been affected by cancer, have developed a web-based mobile application they call Stupid Cancer. The app is designed to connect adolescents and young adults who have cancer, or are cancer survivors, with each other and with resources and information.

When users set up their profiles on the app, they indicate their status as person with cancer or family member/supporter, as well as their geographic region, age, and type and stage of cancer. Then, users can connect with each other in private one-on-one chats or in chat rooms. Users are anonymous.

The Stupid Cancer app, said Mr. Fuehrer, was a natural extension of the nonprofit of the same name – an event-based organization designed to serve the needs for information and connection with others that are in many ways unique to adolescents and young adults.

Mr. Fuehrer, who has a professional background in the pharmaceutical industry, said that he sorely missed that connection during his cancer journeys and saw a big unmet need. “I was the only guy my age in a roomful of men in their 60s and 70s at my urologist’s office,” said Mr. Fuehrer. “Nobody looked like me.”

But even within the adolescent and young adult community, the lived experience of cancer can be much different for a younger patient. “I feel like I missed out on part of my childhood,” said Dane Koomen. When he was diagnosed with advanced Burkitt lymphoma nearly 10 years ago, “Myspace was the only social media out there, and as an 11 year old, I wasn’t exactly going to be hanging out there,” he said.

If Twitter, Snapchat, or Instagram had been available when he was going through cancer treatment, said Mr. Koomen, he could have stayed in better touch with his friends as they finished 6th grade and prepared for the transition to junior high school. “There are experiences I missed – field trips I didn’t go on, parties I missed,” and even vicarious involvement through social media would have been better than the isolation he felt, he said.

He thinks social media could also have helped his friends understand his experience: “If I’d had Snapchat, then they could see what I’m going through, and it would have been easier for people to understand what’s going on,” he said.

Through social media with broader reach, like Twitter or Instagram, he could have found encouragement and hope from inspiring stories of other cancer patients who were completing treatment and reaching the cancer-free status he was hoping for, he said. And he also would have enjoyed telling his story to a wider audience, and gaining strength from others’ well wishes, on Twitter.

Ilia Buhtoiarov, MD, a pediatric oncologist at Cleveland Clinic Children’s Hospital, Ohio, said that he sees different groups using social media platforms in a variety of ways for support and information sharing.

Parents, he said in an interview, are big Facebook users. Beginning with the early, uncertain days after a cancer diagnosis, parents can share a lot of information “in a structured fashion,” through one post. “They can target the post to a number of people – so everyone hears exactly what you want to say,” he said. For parents and other caregivers, this strategy is efficient when time and energy are limited.

Facebook is also useful, he said, for marshaling resources, such as finding help with rides or after-school care for other children and for such things as letting friends know when the patient is feeling well enough to see others.

For young cancer patients, Dr. Buhtoiarov said, a platform like Instagram or Snapchat affords “the opportunity to start a conversation” with peers. “The barriers are lifted quite naturally,” he said, and he sees how “the likes, smiles, and emojis provide support” for the person with cancer as peers follow along with the cancer journey.

Like an increasing number of pediatric oncology programs nationwide, Cleveland Clinic Children’s Hospital has services tailored for adolescents and young adults with cancer, who may “fall through the cracks” between pediatric and adult oncology services. Dr. Buhtoiarov said that among his peers, Twitter is used extensively to keep apprised of clinical trial opportunities and to link to new research in the field. This is especially important for those caring for an age group that’s been identified as significantly underrepresented in clinical trials and for whom cancer survival rates are persistently flat.

Oncologists also need to help patients and families navigate the reams of sometimes unreliable information they’ll find on the Internet, said Dr. Buhtoiarov. Though professionals can connect with each other to help patients find an expert close to home, or to consider enrollment in a clinical trial, patients need to know that “this information should always be discussed with experts,” he said.

[email protected]

The first time Dave Fuehrer was diagnosed with testicular cancer, he was knocked back. The twenty-something competitive bodybuilder, a recent New York State champion, was unprepared for his journey from wellness to disease, and then through treatments and their sequelae.

However, it was the second diagnosis of primary testicular cancer that really got to him, he said. This time, he was a recently married young professional who was working on starting a family. The second round of cancer took parenthood away from him and left him “feeling even more lost and ashamed” than the first diagnosis, he said in an interview. He felt isolated, alone, and very different from most of the other cancer patients he saw.

Now, Mr. Fuehrer and partners, all of whom have been affected by cancer, have developed a web-based mobile application they call Stupid Cancer. The app is designed to connect adolescents and young adults who have cancer, or are cancer survivors, with each other and with resources and information.

When users set up their profiles on the app, they indicate their status as person with cancer or family member/supporter, as well as their geographic region, age, and type and stage of cancer. Then, users can connect with each other in private one-on-one chats or in chat rooms. Users are anonymous.

The Stupid Cancer app, said Mr. Fuehrer, was a natural extension of the nonprofit of the same name – an event-based organization designed to serve the needs for information and connection with others that are in many ways unique to adolescents and young adults.

Mr. Fuehrer, who has a professional background in the pharmaceutical industry, said that he sorely missed that connection during his cancer journeys and saw a big unmet need. “I was the only guy my age in a roomful of men in their 60s and 70s at my urologist’s office,” said Mr. Fuehrer. “Nobody looked like me.”

But even within the adolescent and young adult community, the lived experience of cancer can be much different for a younger patient. “I feel like I missed out on part of my childhood,” said Dane Koomen. When he was diagnosed with advanced Burkitt lymphoma nearly 10 years ago, “Myspace was the only social media out there, and as an 11 year old, I wasn’t exactly going to be hanging out there,” he said.

If Twitter, Snapchat, or Instagram had been available when he was going through cancer treatment, said Mr. Koomen, he could have stayed in better touch with his friends as they finished 6th grade and prepared for the transition to junior high school. “There are experiences I missed – field trips I didn’t go on, parties I missed,” and even vicarious involvement through social media would have been better than the isolation he felt, he said.

He thinks social media could also have helped his friends understand his experience: “If I’d had Snapchat, then they could see what I’m going through, and it would have been easier for people to understand what’s going on,” he said.

Through social media with broader reach, like Twitter or Instagram, he could have found encouragement and hope from inspiring stories of other cancer patients who were completing treatment and reaching the cancer-free status he was hoping for, he said. And he also would have enjoyed telling his story to a wider audience, and gaining strength from others’ well wishes, on Twitter.

Ilia Buhtoiarov, MD, a pediatric oncologist at Cleveland Clinic Children’s Hospital, Ohio, said that he sees different groups using social media platforms in a variety of ways for support and information sharing.

Parents, he said in an interview, are big Facebook users. Beginning with the early, uncertain days after a cancer diagnosis, parents can share a lot of information “in a structured fashion,” through one post. “They can target the post to a number of people – so everyone hears exactly what you want to say,” he said. For parents and other caregivers, this strategy is efficient when time and energy are limited.

Facebook is also useful, he said, for marshaling resources, such as finding help with rides or after-school care for other children and for such things as letting friends know when the patient is feeling well enough to see others.

For young cancer patients, Dr. Buhtoiarov said, a platform like Instagram or Snapchat affords “the opportunity to start a conversation” with peers. “The barriers are lifted quite naturally,” he said, and he sees how “the likes, smiles, and emojis provide support” for the person with cancer as peers follow along with the cancer journey.

Like an increasing number of pediatric oncology programs nationwide, Cleveland Clinic Children’s Hospital has services tailored for adolescents and young adults with cancer, who may “fall through the cracks” between pediatric and adult oncology services. Dr. Buhtoiarov said that among his peers, Twitter is used extensively to keep apprised of clinical trial opportunities and to link to new research in the field. This is especially important for those caring for an age group that’s been identified as significantly underrepresented in clinical trials and for whom cancer survival rates are persistently flat.

Oncologists also need to help patients and families navigate the reams of sometimes unreliable information they’ll find on the Internet, said Dr. Buhtoiarov. Though professionals can connect with each other to help patients find an expert close to home, or to consider enrollment in a clinical trial, patients need to know that “this information should always be discussed with experts,” he said.

[email protected]

The first time Dave Fuehrer was diagnosed with testicular cancer, he was knocked back. The twenty-something competitive bodybuilder, a recent New York State champion, was unprepared for his journey from wellness to disease, and then through treatments and their sequelae.

However, it was the second diagnosis of primary testicular cancer that really got to him, he said. This time, he was a recently married young professional who was working on starting a family. The second round of cancer took parenthood away from him and left him “feeling even more lost and ashamed” than the first diagnosis, he said in an interview. He felt isolated, alone, and very different from most of the other cancer patients he saw.

Now, Mr. Fuehrer and partners, all of whom have been affected by cancer, have developed a web-based mobile application they call Stupid Cancer. The app is designed to connect adolescents and young adults who have cancer, or are cancer survivors, with each other and with resources and information.

When users set up their profiles on the app, they indicate their status as person with cancer or family member/supporter, as well as their geographic region, age, and type and stage of cancer. Then, users can connect with each other in private one-on-one chats or in chat rooms. Users are anonymous.

The Stupid Cancer app, said Mr. Fuehrer, was a natural extension of the nonprofit of the same name – an event-based organization designed to serve the needs for information and connection with others that are in many ways unique to adolescents and young adults.

Mr. Fuehrer, who has a professional background in the pharmaceutical industry, said that he sorely missed that connection during his cancer journeys and saw a big unmet need. “I was the only guy my age in a roomful of men in their 60s and 70s at my urologist’s office,” said Mr. Fuehrer. “Nobody looked like me.”

But even within the adolescent and young adult community, the lived experience of cancer can be much different for a younger patient. “I feel like I missed out on part of my childhood,” said Dane Koomen. When he was diagnosed with advanced Burkitt lymphoma nearly 10 years ago, “Myspace was the only social media out there, and as an 11 year old, I wasn’t exactly going to be hanging out there,” he said.

If Twitter, Snapchat, or Instagram had been available when he was going through cancer treatment, said Mr. Koomen, he could have stayed in better touch with his friends as they finished 6th grade and prepared for the transition to junior high school. “There are experiences I missed – field trips I didn’t go on, parties I missed,” and even vicarious involvement through social media would have been better than the isolation he felt, he said.

He thinks social media could also have helped his friends understand his experience: “If I’d had Snapchat, then they could see what I’m going through, and it would have been easier for people to understand what’s going on,” he said.

Through social media with broader reach, like Twitter or Instagram, he could have found encouragement and hope from inspiring stories of other cancer patients who were completing treatment and reaching the cancer-free status he was hoping for, he said. And he also would have enjoyed telling his story to a wider audience, and gaining strength from others’ well wishes, on Twitter.

Ilia Buhtoiarov, MD, a pediatric oncologist at Cleveland Clinic Children’s Hospital, Ohio, said that he sees different groups using social media platforms in a variety of ways for support and information sharing.

Parents, he said in an interview, are big Facebook users. Beginning with the early, uncertain days after a cancer diagnosis, parents can share a lot of information “in a structured fashion,” through one post. “They can target the post to a number of people – so everyone hears exactly what you want to say,” he said. For parents and other caregivers, this strategy is efficient when time and energy are limited.

Facebook is also useful, he said, for marshaling resources, such as finding help with rides or after-school care for other children and for such things as letting friends know when the patient is feeling well enough to see others.

For young cancer patients, Dr. Buhtoiarov said, a platform like Instagram or Snapchat affords “the opportunity to start a conversation” with peers. “The barriers are lifted quite naturally,” he said, and he sees how “the likes, smiles, and emojis provide support” for the person with cancer as peers follow along with the cancer journey.

Like an increasing number of pediatric oncology programs nationwide, Cleveland Clinic Children’s Hospital has services tailored for adolescents and young adults with cancer, who may “fall through the cracks” between pediatric and adult oncology services. Dr. Buhtoiarov said that among his peers, Twitter is used extensively to keep apprised of clinical trial opportunities and to link to new research in the field. This is especially important for those caring for an age group that’s been identified as significantly underrepresented in clinical trials and for whom cancer survival rates are persistently flat.

Oncologists also need to help patients and families navigate the reams of sometimes unreliable information they’ll find on the Internet, said Dr. Buhtoiarov. Though professionals can connect with each other to help patients find an expert close to home, or to consider enrollment in a clinical trial, patients need to know that “this information should always be discussed with experts,” he said.

[email protected]

MONTREAL – Does rurality matter in cancer treatment? According to lessons from a Scottish study, the answer may be yes, but in unexpected ways.

Patients who lived further away from a cancer treatment center were more likely to be treated within the 62 days postreferral window that the Scottish government has set as a target. Compared with those living within 15 minutes of a cancer center, the adjusted odds ratio for patients living at least an hour away to receive timely treatment was 1.42 (95% confidence interval, 1.25-1.61). For those living on remote islands, the aOR was 1.32 (95% CI, 1.09-1.59).

Kari Oakes/Frontline Medical News

[email protected]

SOURCE: Murchie P. NAPCRG 2017 Abstract CR15.

MONTREAL – Does rurality matter in cancer treatment? According to lessons from a Scottish study, the answer may be yes, but in unexpected ways.

Patients who lived further away from a cancer treatment center were more likely to be treated within the 62 days postreferral window that the Scottish government has set as a target. Compared with those living within 15 minutes of a cancer center, the adjusted odds ratio for patients living at least an hour away to receive timely treatment was 1.42 (95% confidence interval, 1.25-1.61). For those living on remote islands, the aOR was 1.32 (95% CI, 1.09-1.59).

Kari Oakes/Frontline Medical News

[email protected]

SOURCE: Murchie P. NAPCRG 2017 Abstract CR15.

MONTREAL – Does rurality matter in cancer treatment? According to lessons from a Scottish study, the answer may be yes, but in unexpected ways.

Patients who lived further away from a cancer treatment center were more likely to be treated within the 62 days postreferral window that the Scottish government has set as a target. Compared with those living within 15 minutes of a cancer center, the adjusted odds ratio for patients living at least an hour away to receive timely treatment was 1.42 (95% confidence interval, 1.25-1.61). For those living on remote islands, the aOR was 1.32 (95% CI, 1.09-1.59).

Kari Oakes/Frontline Medical News

[email protected]

SOURCE: Murchie P. NAPCRG 2017 Abstract CR15.

For women with young-onset breast cancer, presence of a BRCA mutation did not significantly impact survival, according to results of the Prospective Outcomes in Sporadic versus Hereditary breast cancer (POSH) study.

BRCA-positive and BRCA-negative women had similar overall survival at 2 years, 5 years, and 10 years after diagnosis, according to lead author Ellen R. Copson, MD, a senior lecturer in medical oncology in the cancer sciences division, University of Southampton (England) and her study coauthors.

SOURCE: Copson et al. Lancet Oncol. 2018 Jan 11 doi: 10.1016/S1470-2045(17)30891-4.

For women with young-onset breast cancer, presence of a BRCA mutation did not significantly impact survival, according to results of the Prospective Outcomes in Sporadic versus Hereditary breast cancer (POSH) study.

BRCA-positive and BRCA-negative women had similar overall survival at 2 years, 5 years, and 10 years after diagnosis, according to lead author Ellen R. Copson, MD, a senior lecturer in medical oncology in the cancer sciences division, University of Southampton (England) and her study coauthors.

SOURCE: Copson et al. Lancet Oncol. 2018 Jan 11 doi: 10.1016/S1470-2045(17)30891-4.

For women with young-onset breast cancer, presence of a BRCA mutation did not significantly impact survival, according to results of the Prospective Outcomes in Sporadic versus Hereditary breast cancer (POSH) study.

BRCA-positive and BRCA-negative women had similar overall survival at 2 years, 5 years, and 10 years after diagnosis, according to lead author Ellen R. Copson, MD, a senior lecturer in medical oncology in the cancer sciences division, University of Southampton (England) and her study coauthors.

SOURCE: Copson et al. Lancet Oncol. 2018 Jan 11 doi: 10.1016/S1470-2045(17)30891-4.

Carriers of the BRCA1/2 mutation who undergo risk-reducing salpingo-oophorectomy (RRSO) still face a risk of developing metachronous peritoneal carcinomatosis, according to new findings published in Cancer.

The risk was predominantly observed in BRCA1 mutation carriers, and disease development generally occurred within 5 years following RRSO. Women who underwent RRSO at an age older than that currently recommended also had a higher risk of developing peritoneal carcinoma.

Their median age was 52 years at the time they underwent surgery, and 60 years when they were diagnosed with peritoneal carcinomatosis. As compared with the control group, the patients were older at the time they underwent RRSO (P = .025).

In eight RRSO specimens that were obtained from women who subsequently developed peritoneal carcinomatosis, five (62.5%), had serous tubal intraepithelial carcinoma (STIC) and one had epithelial atypia.

“The findings of the current study can be used to refine gynecologic counseling for BRCA1/2 mutation carriers who consider risk-reducing surgery and to stress the importance of complete RRSO at the recommended ages,” wrote lead author Marline G. Harmsen, MD, PhD, of the Radboud University Medical Center, Nijmegen, the Netherlands.

BRCA1/2 mutation carriers face a higher risk of developing ovarian carcinoma, and RRSO can reduce that risk by 80%-96%. Surgery is recommended for carriers of BRCA1 mutations aged 35-40 years and for BRCA2 mutation carriers aged 40-45 years.

In this study, Dr. Harmsen and her colleagues conducted a literature search in order to collect and analyze clinical and pathological data from women with BRCA1/2 mutation who developed peritoneal carcinomatosis following RRSO. The cases that were identified were then compared with a cohort from a single institution.

Of the 36 cases that were identified, 86.1% were BRCA1 mutation carriers and the remaining 5 patients had a BRCA2 mutation. The median age at the time of surgery differed significantly between BRCA1 (51 years; range, 30-71 years) and BRCA2 mutation carriers (57 years; range, 56-65 years) (P = .006).

The majority of women had undergone salpingo-oophorectomy (31; 86.1%), and 16 (44.4%) had also had a hysterectomy.

The authors found that several statistically significant differences between the case studies and the control group: the median age surgery (52 vs. 46 years), percentage of BRCA1 mutation carriers (86.1% vs. 53.1%, P less than .001), and percentage of serous tubal intraepithelial carcinomas in the RRSO specimens (62.5% vs. 0%; P less than .001).

SOURCE: Hamsen MG et al. Cancer. 2018 Jan 9. doi: 10.1002/cncr.31211.

[email protected]

Carriers of the BRCA1/2 mutation who undergo risk-reducing salpingo-oophorectomy (RRSO) still face a risk of developing metachronous peritoneal carcinomatosis, according to new findings published in Cancer.

The risk was predominantly observed in BRCA1 mutation carriers, and disease development generally occurred within 5 years following RRSO. Women who underwent RRSO at an age older than that currently recommended also had a higher risk of developing peritoneal carcinoma.

Their median age was 52 years at the time they underwent surgery, and 60 years when they were diagnosed with peritoneal carcinomatosis. As compared with the control group, the patients were older at the time they underwent RRSO (P = .025).

In eight RRSO specimens that were obtained from women who subsequently developed peritoneal carcinomatosis, five (62.5%), had serous tubal intraepithelial carcinoma (STIC) and one had epithelial atypia.

“The findings of the current study can be used to refine gynecologic counseling for BRCA1/2 mutation carriers who consider risk-reducing surgery and to stress the importance of complete RRSO at the recommended ages,” wrote lead author Marline G. Harmsen, MD, PhD, of the Radboud University Medical Center, Nijmegen, the Netherlands.

BRCA1/2 mutation carriers face a higher risk of developing ovarian carcinoma, and RRSO can reduce that risk by 80%-96%. Surgery is recommended for carriers of BRCA1 mutations aged 35-40 years and for BRCA2 mutation carriers aged 40-45 years.

In this study, Dr. Harmsen and her colleagues conducted a literature search in order to collect and analyze clinical and pathological data from women with BRCA1/2 mutation who developed peritoneal carcinomatosis following RRSO. The cases that were identified were then compared with a cohort from a single institution.

Of the 36 cases that were identified, 86.1% were BRCA1 mutation carriers and the remaining 5 patients had a BRCA2 mutation. The median age at the time of surgery differed significantly between BRCA1 (51 years; range, 30-71 years) and BRCA2 mutation carriers (57 years; range, 56-65 years) (P = .006).

The majority of women had undergone salpingo-oophorectomy (31; 86.1%), and 16 (44.4%) had also had a hysterectomy.

The authors found that several statistically significant differences between the case studies and the control group: the median age surgery (52 vs. 46 years), percentage of BRCA1 mutation carriers (86.1% vs. 53.1%, P less than .001), and percentage of serous tubal intraepithelial carcinomas in the RRSO specimens (62.5% vs. 0%; P less than .001).

SOURCE: Hamsen MG et al. Cancer. 2018 Jan 9. doi: 10.1002/cncr.31211.

[email protected]

Carriers of the BRCA1/2 mutation who undergo risk-reducing salpingo-oophorectomy (RRSO) still face a risk of developing metachronous peritoneal carcinomatosis, according to new findings published in Cancer.

The risk was predominantly observed in BRCA1 mutation carriers, and disease development generally occurred within 5 years following RRSO. Women who underwent RRSO at an age older than that currently recommended also had a higher risk of developing peritoneal carcinoma.

Their median age was 52 years at the time they underwent surgery, and 60 years when they were diagnosed with peritoneal carcinomatosis. As compared with the control group, the patients were older at the time they underwent RRSO (P = .025).

In eight RRSO specimens that were obtained from women who subsequently developed peritoneal carcinomatosis, five (62.5%), had serous tubal intraepithelial carcinoma (STIC) and one had epithelial atypia.

“The findings of the current study can be used to refine gynecologic counseling for BRCA1/2 mutation carriers who consider risk-reducing surgery and to stress the importance of complete RRSO at the recommended ages,” wrote lead author Marline G. Harmsen, MD, PhD, of the Radboud University Medical Center, Nijmegen, the Netherlands.

BRCA1/2 mutation carriers face a higher risk of developing ovarian carcinoma, and RRSO can reduce that risk by 80%-96%. Surgery is recommended for carriers of BRCA1 mutations aged 35-40 years and for BRCA2 mutation carriers aged 40-45 years.

In this study, Dr. Harmsen and her colleagues conducted a literature search in order to collect and analyze clinical and pathological data from women with BRCA1/2 mutation who developed peritoneal carcinomatosis following RRSO. The cases that were identified were then compared with a cohort from a single institution.

Of the 36 cases that were identified, 86.1% were BRCA1 mutation carriers and the remaining 5 patients had a BRCA2 mutation. The median age at the time of surgery differed significantly between BRCA1 (51 years; range, 30-71 years) and BRCA2 mutation carriers (57 years; range, 56-65 years) (P = .006).

The majority of women had undergone salpingo-oophorectomy (31; 86.1%), and 16 (44.4%) had also had a hysterectomy.

The authors found that several statistically significant differences between the case studies and the control group: the median age surgery (52 vs. 46 years), percentage of BRCA1 mutation carriers (86.1% vs. 53.1%, P less than .001), and percentage of serous tubal intraepithelial carcinomas in the RRSO specimens (62.5% vs. 0%; P less than .001).

SOURCE: Hamsen MG et al. Cancer. 2018 Jan 9. doi: 10.1002/cncr.31211.

[email protected]

Chronic pain after breast reconstruction surgery is a common complaint, but its considerable incidence means that the operation itself may not be to blame, according to a study of almost 2,000 women recruited from the Mastectomy Reconstructive Outcomes Consortium (MROC).

In the February issue of The Breast, investigators from the University of Michigan, Ann Arbor and Memorial Sloan Kettering Cancer Center, New York, wrote that almost half of the study subjects had some level of pain before their operations and that, at 2 years afterward, their pain had increased but not in a clinically meaningful way. This finding is consistent with earlier research, which investigators noted found that “one-fourth to one-half of women who undergo postmastectomy report persistent pain months and years after surgery.”

“Average clinical pain severity was strikingly similar for preoperative and postoperative assessments,” said lead author Randy S. Roth, PhD, of the University of Michigan, and his coauthors. “Postoperative levels of pain, acute postoperative pain and (marginally) level of depression held consistent relationship at 2-year follow-up with all outcome measures.”

The prospective, multicenter cohort study of 1,996 women was undertaken over 5 years. Most patients had immediate (92.7%) and bilateral (53.8%) reconstruction; 47.6% had sentinel lymph node biopsy and 25.9% had axillary lymph node dissection. Most had no adjuvant therapy: 70.3% received no radiation and 52.7% no chemotherapy.

At 2 years, the Numerical Pain Rating Scale (NPRS) measured what Dr. Roth and his coauthors called a “significant increase in pain intensity” – from an average rating of 1.1 to 1.2, an increase of 9%. However, the absolute change and standard deviation (1.7 for both intervals) “suggest that this was not a clinically meaningful change.” The researchers also recorded more complaints of bodily discomfort after 2 years, “but the statistical parameters again indicate little clinically meaningful differences from preoperative status.”

Pain ratings measured with the McGill Pain Questionnaire showed a significant decrease in the MPQ affective pain rating, from 1.6 preoperatively to 0.8 at 2 years (P less than .001), and virtually no change in the MPQ sensory rating, from 3.2 to 3.1.

The researchers drew some conclusions about demographic profiles and pain after breast reconstruction. Older age was associated with more severe pain on NPRS, and higher body mass index was linked with chronic postsurgical pain for the MPQ sensory rating, NPRS score, and body discomfort scores.

Treatment characteristics associated with chronic postsurgical pain (CPSP) include radiation therapy during or after reconstruction and chemotherapy before reconstruction. Chemotherapy during or after reconstruction was associated with higher MPQ affective rating scores at 2 years (P = .011), as was chemotherapy both before and during or after reconstruction (P = .001). The latter also was linked to higher NPRS scores (P = .0015).

The type of surgery also was a factor in CPSP, the researchers wrote. Both MPQ sensory and affective ratings were higher in women who had free transverse flap surgery, or deep or superficial inferior epigastric perforator surgery than in women who had tissue expander/implant reconstruction. Lymph node status and timing of surgery had no impact on chronic pain.

One noteworthy finding, Dr. Roth and his coauthors wrote, is that “careful examination of our data suggests that CPSP following breast reconstruction may be of less clinical concern as a direct consequence of breast reconstruction than suggested by previous investigations of major surgery, including mastectomy and breast reconstruction.” Future studies of chronic postsurgical pain in breast reconstruction “will require greater methodological rigor” to reach more sound conclusions to use in patient counseling.

Dr. Roth and his coauthors had no financial relationships to disclose.

SOURCE: Roth RS et al. Breast 2018;37:119-25.

Chronic pain after breast reconstruction surgery is a common complaint, but its considerable incidence means that the operation itself may not be to blame, according to a study of almost 2,000 women recruited from the Mastectomy Reconstructive Outcomes Consortium (MROC).

In the February issue of The Breast, investigators from the University of Michigan, Ann Arbor and Memorial Sloan Kettering Cancer Center, New York, wrote that almost half of the study subjects had some level of pain before their operations and that, at 2 years afterward, their pain had increased but not in a clinically meaningful way. This finding is consistent with earlier research, which investigators noted found that “one-fourth to one-half of women who undergo postmastectomy report persistent pain months and years after surgery.”

“Average clinical pain severity was strikingly similar for preoperative and postoperative assessments,” said lead author Randy S. Roth, PhD, of the University of Michigan, and his coauthors. “Postoperative levels of pain, acute postoperative pain and (marginally) level of depression held consistent relationship at 2-year follow-up with all outcome measures.”

The prospective, multicenter cohort study of 1,996 women was undertaken over 5 years. Most patients had immediate (92.7%) and bilateral (53.8%) reconstruction; 47.6% had sentinel lymph node biopsy and 25.9% had axillary lymph node dissection. Most had no adjuvant therapy: 70.3% received no radiation and 52.7% no chemotherapy.

At 2 years, the Numerical Pain Rating Scale (NPRS) measured what Dr. Roth and his coauthors called a “significant increase in pain intensity” – from an average rating of 1.1 to 1.2, an increase of 9%. However, the absolute change and standard deviation (1.7 for both intervals) “suggest that this was not a clinically meaningful change.” The researchers also recorded more complaints of bodily discomfort after 2 years, “but the statistical parameters again indicate little clinically meaningful differences from preoperative status.”

Pain ratings measured with the McGill Pain Questionnaire showed a significant decrease in the MPQ affective pain rating, from 1.6 preoperatively to 0.8 at 2 years (P less than .001), and virtually no change in the MPQ sensory rating, from 3.2 to 3.1.

The researchers drew some conclusions about demographic profiles and pain after breast reconstruction. Older age was associated with more severe pain on NPRS, and higher body mass index was linked with chronic postsurgical pain for the MPQ sensory rating, NPRS score, and body discomfort scores.

Treatment characteristics associated with chronic postsurgical pain (CPSP) include radiation therapy during or after reconstruction and chemotherapy before reconstruction. Chemotherapy during or after reconstruction was associated with higher MPQ affective rating scores at 2 years (P = .011), as was chemotherapy both before and during or after reconstruction (P = .001). The latter also was linked to higher NPRS scores (P = .0015).

The type of surgery also was a factor in CPSP, the researchers wrote. Both MPQ sensory and affective ratings were higher in women who had free transverse flap surgery, or deep or superficial inferior epigastric perforator surgery than in women who had tissue expander/implant reconstruction. Lymph node status and timing of surgery had no impact on chronic pain.

One noteworthy finding, Dr. Roth and his coauthors wrote, is that “careful examination of our data suggests that CPSP following breast reconstruction may be of less clinical concern as a direct consequence of breast reconstruction than suggested by previous investigations of major surgery, including mastectomy and breast reconstruction.” Future studies of chronic postsurgical pain in breast reconstruction “will require greater methodological rigor” to reach more sound conclusions to use in patient counseling.

Dr. Roth and his coauthors had no financial relationships to disclose.

SOURCE: Roth RS et al. Breast 2018;37:119-25.

Chronic pain after breast reconstruction surgery is a common complaint, but its considerable incidence means that the operation itself may not be to blame, according to a study of almost 2,000 women recruited from the Mastectomy Reconstructive Outcomes Consortium (MROC).

In the February issue of The Breast, investigators from the University of Michigan, Ann Arbor and Memorial Sloan Kettering Cancer Center, New York, wrote that almost half of the study subjects had some level of pain before their operations and that, at 2 years afterward, their pain had increased but not in a clinically meaningful way. This finding is consistent with earlier research, which investigators noted found that “one-fourth to one-half of women who undergo postmastectomy report persistent pain months and years after surgery.”

“Average clinical pain severity was strikingly similar for preoperative and postoperative assessments,” said lead author Randy S. Roth, PhD, of the University of Michigan, and his coauthors. “Postoperative levels of pain, acute postoperative pain and (marginally) level of depression held consistent relationship at 2-year follow-up with all outcome measures.”

The prospective, multicenter cohort study of 1,996 women was undertaken over 5 years. Most patients had immediate (92.7%) and bilateral (53.8%) reconstruction; 47.6% had sentinel lymph node biopsy and 25.9% had axillary lymph node dissection. Most had no adjuvant therapy: 70.3% received no radiation and 52.7% no chemotherapy.

At 2 years, the Numerical Pain Rating Scale (NPRS) measured what Dr. Roth and his coauthors called a “significant increase in pain intensity” – from an average rating of 1.1 to 1.2, an increase of 9%. However, the absolute change and standard deviation (1.7 for both intervals) “suggest that this was not a clinically meaningful change.” The researchers also recorded more complaints of bodily discomfort after 2 years, “but the statistical parameters again indicate little clinically meaningful differences from preoperative status.”

Pain ratings measured with the McGill Pain Questionnaire showed a significant decrease in the MPQ affective pain rating, from 1.6 preoperatively to 0.8 at 2 years (P less than .001), and virtually no change in the MPQ sensory rating, from 3.2 to 3.1.

The researchers drew some conclusions about demographic profiles and pain after breast reconstruction. Older age was associated with more severe pain on NPRS, and higher body mass index was linked with chronic postsurgical pain for the MPQ sensory rating, NPRS score, and body discomfort scores.

Treatment characteristics associated with chronic postsurgical pain (CPSP) include radiation therapy during or after reconstruction and chemotherapy before reconstruction. Chemotherapy during or after reconstruction was associated with higher MPQ affective rating scores at 2 years (P = .011), as was chemotherapy both before and during or after reconstruction (P = .001). The latter also was linked to higher NPRS scores (P = .0015).

The type of surgery also was a factor in CPSP, the researchers wrote. Both MPQ sensory and affective ratings were higher in women who had free transverse flap surgery, or deep or superficial inferior epigastric perforator surgery than in women who had tissue expander/implant reconstruction. Lymph node status and timing of surgery had no impact on chronic pain.

One noteworthy finding, Dr. Roth and his coauthors wrote, is that “careful examination of our data suggests that CPSP following breast reconstruction may be of less clinical concern as a direct consequence of breast reconstruction than suggested by previous investigations of major surgery, including mastectomy and breast reconstruction.” Future studies of chronic postsurgical pain in breast reconstruction “will require greater methodological rigor” to reach more sound conclusions to use in patient counseling.

Dr. Roth and his coauthors had no financial relationships to disclose.

SOURCE: Roth RS et al. Breast 2018;37:119-25.

SAN ANTONIO – Adjuvant endocrine therapies improve outcomes of premenopausal breast cancer in the long term, with absolute benefit varying somewhat by therapy and by patient and disease characteristics, according to planned updates of a pair of pivotal phase 3 trials.

The trials – TEXT (Tamoxifen and Exemestane Trial) and SOFT (Suppression of Ovarian Function Trial) – are coordinated by the International Breast Cancer Study Group and together randomized more than 5,000 premenopausal women with early hormone receptor–positive breast cancer to 5 years of various types of adjuvant endocrine therapy. Their initial results, reported several years ago, form part of treatment guidelines that are used worldwide.

Clinical implications

These updates, along with other emerging data, can be used to optimize endocrine therapy for younger women with breast cancer, according to invited discussant Ann H. Partridge, MD, of Dana Farber Cancer Institute in Boston.

“For higher-risk disease, we should be considering OFS. At this point in time, I don’t think HER2 status alone should drive this decision,” she commented. “If you are getting OFS, what do we do, AI versus tamoxifen? Well, we do see a large improvement in disease-free survival [with AIs], so many women will want to use AIs. Yet tamoxifen is still reasonable, especially in light of the survival data.”

Data on switch strategies and extended-duration therapy are generally lacking at present for the premenopausal population, Dr. Partridge noted. “That’s something that we still need to extrapolate from data that’s predominantly in postmenopausal women.”

Another compelling question is whether OFS can be used instead of chemo for some patients. “We are increasingly recognizing that women with higher-risk anatomy and lower-risk biology having endocrine-responsive tumors may get more bang for the buck from the optimizing of hormonal therapy, and chemo may not add much,” she said.

Both short- and long-term toxicities of the various endocrine therapies and, for aromatase inhibitors, the potential for breakthrough (return of estradiol levels to premenopausal levels) also need to be considered, Dr. Partridge stressed. “And ultimately, patient preference and tolerance are key. After all, the best treatment is the one the patient will take.”

“We need to follow these women on TEXT and SOFT very long term. It would be a crime not to follow these women further out,” she maintained. “We need to conduct real-world comparative effectiveness research to understand the risks and benefits of OFS more fully in our survivors. Then, as we start to suppress more ovaries in more women with breast cancer, we need to be aware clinically of these risks, and we need to share this awareness with their primary care providers because we need to optimize in particular their cardiovascular risk factors, and screen and treat for potential comorbidities that they may be at higher risk for.”
 

Joint TEXT and SOFT update

Initial results of the joint TEXT and SOFT analysis, reported after a median follow-up of 5.7 years, showed that exemestane plus OFS was superior to tamoxifen plus OFS for the primary outcome, providing a significant 3.8% absolute gain in 5-year disease-free survival (N Engl J Med. 2014;371:107-18).

The updated joint analysis, now with a median follow-up of 9 years and based on data from 4,690 women, showed that the 8-year rate of disease-free survival was 86.8% with exemestane plus OFS versus 82.8% with tamoxifen plus OFS (hazard ratio, 0.77; P = .0006), for a similar absolute benefit of 4.0%, reported Prudence Francis, MD, of the University of Melbourne, head of Medical Oncology in the Breast Service at the Peter MacCallum Cancer Centre, Melbourne.

In stratified analysis, absolute benefit tended to be greater among women in TEXT who received chemotherapy (6.0%); intermediate among women in TEXT who did not receive chemotherapy (3.7%) and women in SOFT who received prior chemotherapy (3.7%); and less among women in SOFT who did not receive chemotherapy (1.9%).

Exemestane plus OFS was also superior to tamoxifen plus OFS in terms of breast cancer–free interval, with an absolute 4.1% benefit (P = .0002), and distant recurrence–free interval, with an absolute 2.1% benefit (P = .02). Overall survival did not differ significantly between arms.

Among the 86% of patients with HER2-negative disease, exemestane plus OFS netted an absolute disease-free survival gain of 5.4% and an absolute distant recurrence–free interval gain of 3.4%. There was a consistent relative treatment benefit across subgroups, but larger absolute benefit, on the order of 5%-9%, in women given chemotherapy and in those younger than 35 years.

“Results for the HER2-positive subgroup require further investigation,” Dr. Francis said. “The trials enrolled both before and after the routine use of adjuvant trastuzumab, and a significant proportion of the patients with HER2-positive breast cancer did not receive adjuvant HER2-targeted therapy.”

In the entire joint-analysis population, exemestane plus OFS was associated with higher rates of musculoskeletal events of grade 3 or 4 (11% vs. 6%) and osteoporosis of grade 2-4 (15% vs. 7%), while tamoxifen plus OFS was associated with a higher rate of thrombosis/embolism of grade 2-4 (2.3% vs. 1.2%) and more cases of endometrial cancer (9 vs. 4 cases). At 4 years, early discontinuation of oral endocrine therapy was greater for exemestane than for tamoxifen (25% vs. 19%).

“After longer follow-up, with a median of 9 years, the combined analysis results confirm a statistically significant improvement in disease outcomes with exemestane plus ovarian suppression. As is critical given the long natural history of estrogen receptor–positive breast cancer, follow-up in these trials is currently continuing,” Dr. Francis summarized.

“To optimally translate the observed absolute trial improvements into clinical practice, oncologists need to discuss and weigh the potential benefits and toxicities in each individual patient who is premenopausal with hormone receptor–positive breast cancer,” she recommended.

Session attendee Hope S. Rugo, MD, of the University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, noted that exemestane had superior benefit despite the 25% rate of early discontinuation. “I wonder if one of the interpretations of that, given the toxicity of this therapy for very young women, is that we need some but maybe not so much. Maybe they don’t need 5 years altogether,” she said.

“The fact that they stopped their assigned endocrine therapy doesn’t mean that they didn’t continue any therapy. They may have switched over to tamoxifen or they may have decided they wanted to have a baby or there may have been many other things,” Dr. Francis replied, noting that analyses sorting out the reasons for early discontinuation are planned.

Session attendee Mark E. Sherman, MD, of the Mayo Clinic, Jacksonville, Fla., asked, “Do you have any ability to test for tamoxifen metabolites? It’s possible that a third to a half of patients got reduced benefit from that drug.”

Banked samples are available and a substudy is planned, according to Dr. Francis. “We haven’t got data on that yet, but yes, we are analyzing that.”
 

SOFT update

Initial results of the SOFT trial, reported after a median follow-up of 5.6 years, showed that adding OFS to tamoxifen did not significantly improve disease-free survival over tamoxifen alone in the entire trial population (N Engl J Med. 2015;372:436-46). However, there was benefit for women who received chemotherapy and remained premenopausal.

The updated SOFT analysis, now with a median follow-up of 8 years, focused mainly on the 1,018 women given tamoxifen alone and the 1,015 women given tamoxifen plus OFS. (Another 1,014 women were given exemestane plus OFS.)

“SOFT is now positive for its primary endpoint,” reported first author Gini Fleming, MD, director of the Medical Oncology Breast Program and medical oncology director of Gynecologic Oncology at University of Chicago Medicine. The 8-year disease-free survival rate was 83.2% with tamoxifen plus OFS, compared with 78.9% with tamoxifen alone (HR, 0.76; P = .009), corresponding to a 4.2% gain in this outcome. The relative benefit was identical whether patients had received chemotherapy or not, but absolute benefit was greater for those who had (5.3%), as well as for patients younger than 35 years (8.7%).

In addition, exemestane plus OFS was superior to tamoxifen alone (85.9% vs. 78.9%; HR, 0.65), with an absolute benefit of 7.0%. Again, absolute benefit was more pronounced among women who had received prior chemotherapy (9.0%) or were younger than 35 years (13.1%).

The relative disease-free survival benefit of tamoxifen plus OFS over tamoxifen alone was similar across most subgroups stratified by disease characteristics, but patients with HER2-positive disease derived greater relative benefit from the combination as compared with their HER2-negative counterparts (P = .04 for interaction). “When we look at the combination of exemestane plus OFS versus tamoxifen, this heterogeneity is no longer seen,” Dr. Fleming noted.

In the entire trial population, there was no significant benefit of tamoxifen plus OFS over tamoxifen alone for distant recurrence-free interval and a small, significant absolute 1.9% gain in overall survival.

“The cohort who had elected to receive no prior chemotherapy did exceedingly well regardless of therapy,” she said, with little difference in overall survival across the three arms. “There were only 24 deaths total in this cohort, and 12 of those deaths were in the setting of no distant recurrence.”

On the other hand, among the women who received chemotherapy, there were significant absolute overall survival benefits of 4.3% with tamoxifen plus OFS and 2.1% with exemestane plus OFS, over tamoxifen alone. “This late emergence of an overall survival benefit is consistent with the time course of events in estrogen receptor–positive breast cancer,” Dr. Fleming commented.

The proportion of patients who stopped their oral endocrine therapy early was 22.5% with tamoxifen alone and 18.5% with tamoxifen plus OFS. (It was 27.8% with exemestane plus OFS.) “Almost a quarter of the patients on either tamoxifen arm were using extended oral endocrine therapy at 6 years or later prior to any disease progression. Only about 12% of patients in the exemestane group were doing so,” she noted.

There were more cases of endometrial cancer with tamoxifen alone than with tamoxifen plus OFS (7 vs. 4 cases). Thrombosis/embolism of grade 2-4 occurred in 2.2% of each group (and 0.9% of the exemestane plus OFS group). Musculoskeletal symptoms of grade 3 or 4 occurred in 6.7% of patients with tamoxifen alone and 5.9% with tamoxifen plus OFS, but 12.0% with exemestane plus OFS. Respective rates of osteoporosis grade 2-4 were 3.9%, 6.1%, and 11.9%.

“The addition of OFS to tamoxifen significantly improves disease-free survival at 8 years’ median follow-up, and disease-free survival benefits are further improved by the use of exemestane plus OFS,” Dr. Fleming summarized. “Follow-up, which is critically important given the long natural history of ER-positive disease, continues.”

Session attendee Matthew P. Goetz, MD, of the Mayo Clinic, Rochester, Minn., commented, “For the primary endpoint, I was looking at the tail for tamoxifen. It seemed that there was a relatively rapid drop-off between year 5 and this 8-year follow-up. Have you looked carefully to see whether there is a difference between those who stayed on their therapy versus those who went off it per protocol? That is, extended versus not extended? The question is whether there is a carry-over effect, if you will, that is different in those with OFS versus those not.”

“The percent who went on to extended therapy between the tamoxifen and the tamoxifen plus OFS was fairly similar,” Dr. Fleming replied. “But the answer is no, we have not yet done any sort of per protocol analysis.”

Session attendee Steven Vogl, MD, of Montefiore Medical Center, New York, commented, “I worry about your control group. I’m worried, first, how many of your tamoxifen patients lost their menses and became postmenopausal in those 5 years? And of those, why didn’t they switch to an aromatase inhibitor? Only 25% of the patients continued after the 5 years according to your slide, and all of those patients should either have stayed on tamoxifen or switched to an aromatase inhibitor, now probably for 2 years at least.”

“We have not yet looked at data for who became amenorrheic during treatment, although we have it. However, it’s certainly possible to become amenorrheic on tamoxifen and not be postmenopausal, and we didn’t regularly collect estradiol levels on any but the very small subset of women in the SOFT-S trial. So I don’t know that we have exactly the data that you’re looking for,” Dr. Fleming said. “Many of these women are obviously at very, very low risk and have done well with 5 years of tamoxifen alone, and I don’t know, even given current guidelines, that extended tamoxifen would add a lot to that.”

Finally, session attendee Richard Gray, professor of medical statistics at the University of Oxford (England), wondered, “What is the certainty that follow-up will happen? Because obviously, prolonged follow-up is expensive and there are controversies about that. But this would be the one study you would really want to have 15- and 20-year data on.”

“We are working very, very hard on that,” Dr. Fleming replied. “NCI granted additional funds to institutions for prolonging follow-up, and IBCSG has been ceaselessly working to look for funding to continue it. So I think it’s relatively certain that it will happen.”

Dr. Francis disclosed that she has received fees for non-CME services from AstraZeneca and has given an overseas lecture for Pfizer. Dr. Fleming disclosed that she had no relevant financial relationships with commercial interests. The trials received financial support from Pfizer and Ipsen.

SOURCES: Francis et al. SABCS Abstract GS4-02; Fleming et al. SABCS Abstract GS4-03
 

SAN ANTONIO – Adjuvant endocrine therapies improve outcomes of premenopausal breast cancer in the long term, with absolute benefit varying somewhat by therapy and by patient and disease characteristics, according to planned updates of a pair of pivotal phase 3 trials.

The trials – TEXT (Tamoxifen and Exemestane Trial) and SOFT (Suppression of Ovarian Function Trial) – are coordinated by the International Breast Cancer Study Group and together randomized more than 5,000 premenopausal women with early hormone receptor–positive breast cancer to 5 years of various types of adjuvant endocrine therapy. Their initial results, reported several years ago, form part of treatment guidelines that are used worldwide.

Clinical implications

These updates, along with other emerging data, can be used to optimize endocrine therapy for younger women with breast cancer, according to invited discussant Ann H. Partridge, MD, of Dana Farber Cancer Institute in Boston.

“For higher-risk disease, we should be considering OFS. At this point in time, I don’t think HER2 status alone should drive this decision,” she commented. “If you are getting OFS, what do we do, AI versus tamoxifen? Well, we do see a large improvement in disease-free survival [with AIs], so many women will want to use AIs. Yet tamoxifen is still reasonable, especially in light of the survival data.”

Data on switch strategies and extended-duration therapy are generally lacking at present for the premenopausal population, Dr. Partridge noted. “That’s something that we still need to extrapolate from data that’s predominantly in postmenopausal women.”

Another compelling question is whether OFS can be used instead of chemo for some patients. “We are increasingly recognizing that women with higher-risk anatomy and lower-risk biology having endocrine-responsive tumors may get more bang for the buck from the optimizing of hormonal therapy, and chemo may not add much,” she said.

Both short- and long-term toxicities of the various endocrine therapies and, for aromatase inhibitors, the potential for breakthrough (return of estradiol levels to premenopausal levels) also need to be considered, Dr. Partridge stressed. “And ultimately, patient preference and tolerance are key. After all, the best treatment is the one the patient will take.”

“We need to follow these women on TEXT and SOFT very long term. It would be a crime not to follow these women further out,” she maintained. “We need to conduct real-world comparative effectiveness research to understand the risks and benefits of OFS more fully in our survivors. Then, as we start to suppress more ovaries in more women with breast cancer, we need to be aware clinically of these risks, and we need to share this awareness with their primary care providers because we need to optimize in particular their cardiovascular risk factors, and screen and treat for potential comorbidities that they may be at higher risk for.”
 

Joint TEXT and SOFT update

Initial results of the joint TEXT and SOFT analysis, reported after a median follow-up of 5.7 years, showed that exemestane plus OFS was superior to tamoxifen plus OFS for the primary outcome, providing a significant 3.8% absolute gain in 5-year disease-free survival (N Engl J Med. 2014;371:107-18).

The updated joint analysis, now with a median follow-up of 9 years and based on data from 4,690 women, showed that the 8-year rate of disease-free survival was 86.8% with exemestane plus OFS versus 82.8% with tamoxifen plus OFS (hazard ratio, 0.77; P = .0006), for a similar absolute benefit of 4.0%, reported Prudence Francis, MD, of the University of Melbourne, head of Medical Oncology in the Breast Service at the Peter MacCallum Cancer Centre, Melbourne.

In stratified analysis, absolute benefit tended to be greater among women in TEXT who received chemotherapy (6.0%); intermediate among women in TEXT who did not receive chemotherapy (3.7%) and women in SOFT who received prior chemotherapy (3.7%); and less among women in SOFT who did not receive chemotherapy (1.9%).

Exemestane plus OFS was also superior to tamoxifen plus OFS in terms of breast cancer–free interval, with an absolute 4.1% benefit (P = .0002), and distant recurrence–free interval, with an absolute 2.1% benefit (P = .02). Overall survival did not differ significantly between arms.

Among the 86% of patients with HER2-negative disease, exemestane plus OFS netted an absolute disease-free survival gain of 5.4% and an absolute distant recurrence–free interval gain of 3.4%. There was a consistent relative treatment benefit across subgroups, but larger absolute benefit, on the order of 5%-9%, in women given chemotherapy and in those younger than 35 years.

“Results for the HER2-positive subgroup require further investigation,” Dr. Francis said. “The trials enrolled both before and after the routine use of adjuvant trastuzumab, and a significant proportion of the patients with HER2-positive breast cancer did not receive adjuvant HER2-targeted therapy.”

In the entire joint-analysis population, exemestane plus OFS was associated with higher rates of musculoskeletal events of grade 3 or 4 (11% vs. 6%) and osteoporosis of grade 2-4 (15% vs. 7%), while tamoxifen plus OFS was associated with a higher rate of thrombosis/embolism of grade 2-4 (2.3% vs. 1.2%) and more cases of endometrial cancer (9 vs. 4 cases). At 4 years, early discontinuation of oral endocrine therapy was greater for exemestane than for tamoxifen (25% vs. 19%).

“After longer follow-up, with a median of 9 years, the combined analysis results confirm a statistically significant improvement in disease outcomes with exemestane plus ovarian suppression. As is critical given the long natural history of estrogen receptor–positive breast cancer, follow-up in these trials is currently continuing,” Dr. Francis summarized.

“To optimally translate the observed absolute trial improvements into clinical practice, oncologists need to discuss and weigh the potential benefits and toxicities in each individual patient who is premenopausal with hormone receptor–positive breast cancer,” she recommended.

Session attendee Hope S. Rugo, MD, of the University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, noted that exemestane had superior benefit despite the 25% rate of early discontinuation. “I wonder if one of the interpretations of that, given the toxicity of this therapy for very young women, is that we need some but maybe not so much. Maybe they don’t need 5 years altogether,” she said.

“The fact that they stopped their assigned endocrine therapy doesn’t mean that they didn’t continue any therapy. They may have switched over to tamoxifen or they may have decided they wanted to have a baby or there may have been many other things,” Dr. Francis replied, noting that analyses sorting out the reasons for early discontinuation are planned.

Session attendee Mark E. Sherman, MD, of the Mayo Clinic, Jacksonville, Fla., asked, “Do you have any ability to test for tamoxifen metabolites? It’s possible that a third to a half of patients got reduced benefit from that drug.”

Banked samples are available and a substudy is planned, according to Dr. Francis. “We haven’t got data on that yet, but yes, we are analyzing that.”
 

SOFT update

Initial results of the SOFT trial, reported after a median follow-up of 5.6 years, showed that adding OFS to tamoxifen did not significantly improve disease-free survival over tamoxifen alone in the entire trial population (N Engl J Med. 2015;372:436-46). However, there was benefit for women who received chemotherapy and remained premenopausal.

The updated SOFT analysis, now with a median follow-up of 8 years, focused mainly on the 1,018 women given tamoxifen alone and the 1,015 women given tamoxifen plus OFS. (Another 1,014 women were given exemestane plus OFS.)

“SOFT is now positive for its primary endpoint,” reported first author Gini Fleming, MD, director of the Medical Oncology Breast Program and medical oncology director of Gynecologic Oncology at University of Chicago Medicine. The 8-year disease-free survival rate was 83.2% with tamoxifen plus OFS, compared with 78.9% with tamoxifen alone (HR, 0.76; P = .009), corresponding to a 4.2% gain in this outcome. The relative benefit was identical whether patients had received chemotherapy or not, but absolute benefit was greater for those who had (5.3%), as well as for patients younger than 35 years (8.7%).

In addition, exemestane plus OFS was superior to tamoxifen alone (85.9% vs. 78.9%; HR, 0.65), with an absolute benefit of 7.0%. Again, absolute benefit was more pronounced among women who had received prior chemotherapy (9.0%) or were younger than 35 years (13.1%).

The relative disease-free survival benefit of tamoxifen plus OFS over tamoxifen alone was similar across most subgroups stratified by disease characteristics, but patients with HER2-positive disease derived greater relative benefit from the combination as compared with their HER2-negative counterparts (P = .04 for interaction). “When we look at the combination of exemestane plus OFS versus tamoxifen, this heterogeneity is no longer seen,” Dr. Fleming noted.

In the entire trial population, there was no significant benefit of tamoxifen plus OFS over tamoxifen alone for distant recurrence-free interval and a small, significant absolute 1.9% gain in overall survival.

“The cohort who had elected to receive no prior chemotherapy did exceedingly well regardless of therapy,” she said, with little difference in overall survival across the three arms. “There were only 24 deaths total in this cohort, and 12 of those deaths were in the setting of no distant recurrence.”

On the other hand, among the women who received chemotherapy, there were significant absolute overall survival benefits of 4.3% with tamoxifen plus OFS and 2.1% with exemestane plus OFS, over tamoxifen alone. “This late emergence of an overall survival benefit is consistent with the time course of events in estrogen receptor–positive breast cancer,” Dr. Fleming commented.

The proportion of patients who stopped their oral endocrine therapy early was 22.5% with tamoxifen alone and 18.5% with tamoxifen plus OFS. (It was 27.8% with exemestane plus OFS.) “Almost a quarter of the patients on either tamoxifen arm were using extended oral endocrine therapy at 6 years or later prior to any disease progression. Only about 12% of patients in the exemestane group were doing so,” she noted.

There were more cases of endometrial cancer with tamoxifen alone than with tamoxifen plus OFS (7 vs. 4 cases). Thrombosis/embolism of grade 2-4 occurred in 2.2% of each group (and 0.9% of the exemestane plus OFS group). Musculoskeletal symptoms of grade 3 or 4 occurred in 6.7% of patients with tamoxifen alone and 5.9% with tamoxifen plus OFS, but 12.0% with exemestane plus OFS. Respective rates of osteoporosis grade 2-4 were 3.9%, 6.1%, and 11.9%.

“The addition of OFS to tamoxifen significantly improves disease-free survival at 8 years’ median follow-up, and disease-free survival benefits are further improved by the use of exemestane plus OFS,” Dr. Fleming summarized. “Follow-up, which is critically important given the long natural history of ER-positive disease, continues.”

Session attendee Matthew P. Goetz, MD, of the Mayo Clinic, Rochester, Minn., commented, “For the primary endpoint, I was looking at the tail for tamoxifen. It seemed that there was a relatively rapid drop-off between year 5 and this 8-year follow-up. Have you looked carefully to see whether there is a difference between those who stayed on their therapy versus those who went off it per protocol? That is, extended versus not extended? The question is whether there is a carry-over effect, if you will, that is different in those with OFS versus those not.”

“The percent who went on to extended therapy between the tamoxifen and the tamoxifen plus OFS was fairly similar,” Dr. Fleming replied. “But the answer is no, we have not yet done any sort of per protocol analysis.”

Session attendee Steven Vogl, MD, of Montefiore Medical Center, New York, commented, “I worry about your control group. I’m worried, first, how many of your tamoxifen patients lost their menses and became postmenopausal in those 5 years? And of those, why didn’t they switch to an aromatase inhibitor? Only 25% of the patients continued after the 5 years according to your slide, and all of those patients should either have stayed on tamoxifen or switched to an aromatase inhibitor, now probably for 2 years at least.”

“We have not yet looked at data for who became amenorrheic during treatment, although we have it. However, it’s certainly possible to become amenorrheic on tamoxifen and not be postmenopausal, and we didn’t regularly collect estradiol levels on any but the very small subset of women in the SOFT-S trial. So I don’t know that we have exactly the data that you’re looking for,” Dr. Fleming said. “Many of these women are obviously at very, very low risk and have done well with 5 years of tamoxifen alone, and I don’t know, even given current guidelines, that extended tamoxifen would add a lot to that.”

Finally, session attendee Richard Gray, professor of medical statistics at the University of Oxford (England), wondered, “What is the certainty that follow-up will happen? Because obviously, prolonged follow-up is expensive and there are controversies about that. But this would be the one study you would really want to have 15- and 20-year data on.”

“We are working very, very hard on that,” Dr. Fleming replied. “NCI granted additional funds to institutions for prolonging follow-up, and IBCSG has been ceaselessly working to look for funding to continue it. So I think it’s relatively certain that it will happen.”

Dr. Francis disclosed that she has received fees for non-CME services from AstraZeneca and has given an overseas lecture for Pfizer. Dr. Fleming disclosed that she had no relevant financial relationships with commercial interests. The trials received financial support from Pfizer and Ipsen.

SOURCES: Francis et al. SABCS Abstract GS4-02; Fleming et al. SABCS Abstract GS4-03
 

SAN ANTONIO – Adjuvant endocrine therapies improve outcomes of premenopausal breast cancer in the long term, with absolute benefit varying somewhat by therapy and by patient and disease characteristics, according to planned updates of a pair of pivotal phase 3 trials.

The trials – TEXT (Tamoxifen and Exemestane Trial) and SOFT (Suppression of Ovarian Function Trial) – are coordinated by the International Breast Cancer Study Group and together randomized more than 5,000 premenopausal women with early hormone receptor–positive breast cancer to 5 years of various types of adjuvant endocrine therapy. Their initial results, reported several years ago, form part of treatment guidelines that are used worldwide.

Clinical implications

These updates, along with other emerging data, can be used to optimize endocrine therapy for younger women with breast cancer, according to invited discussant Ann H. Partridge, MD, of Dana Farber Cancer Institute in Boston.

“For higher-risk disease, we should be considering OFS. At this point in time, I don’t think HER2 status alone should drive this decision,” she commented. “If you are getting OFS, what do we do, AI versus tamoxifen? Well, we do see a large improvement in disease-free survival [with AIs], so many women will want to use AIs. Yet tamoxifen is still reasonable, especially in light of the survival data.”

Data on switch strategies and extended-duration therapy are generally lacking at present for the premenopausal population, Dr. Partridge noted. “That’s something that we still need to extrapolate from data that’s predominantly in postmenopausal women.”

Another compelling question is whether OFS can be used instead of chemo for some patients. “We are increasingly recognizing that women with higher-risk anatomy and lower-risk biology having endocrine-responsive tumors may get more bang for the buck from the optimizing of hormonal therapy, and chemo may not add much,” she said.

Both short- and long-term toxicities of the various endocrine therapies and, for aromatase inhibitors, the potential for breakthrough (return of estradiol levels to premenopausal levels) also need to be considered, Dr. Partridge stressed. “And ultimately, patient preference and tolerance are key. After all, the best treatment is the one the patient will take.”

“We need to follow these women on TEXT and SOFT very long term. It would be a crime not to follow these women further out,” she maintained. “We need to conduct real-world comparative effectiveness research to understand the risks and benefits of OFS more fully in our survivors. Then, as we start to suppress more ovaries in more women with breast cancer, we need to be aware clinically of these risks, and we need to share this awareness with their primary care providers because we need to optimize in particular their cardiovascular risk factors, and screen and treat for potential comorbidities that they may be at higher risk for.”
 

Joint TEXT and SOFT update

Initial results of the joint TEXT and SOFT analysis, reported after a median follow-up of 5.7 years, showed that exemestane plus OFS was superior to tamoxifen plus OFS for the primary outcome, providing a significant 3.8% absolute gain in 5-year disease-free survival (N Engl J Med. 2014;371:107-18).

The updated joint analysis, now with a median follow-up of 9 years and based on data from 4,690 women, showed that the 8-year rate of disease-free survival was 86.8% with exemestane plus OFS versus 82.8% with tamoxifen plus OFS (hazard ratio, 0.77; P = .0006), for a similar absolute benefit of 4.0%, reported Prudence Francis, MD, of the University of Melbourne, head of Medical Oncology in the Breast Service at the Peter MacCallum Cancer Centre, Melbourne.

In stratified analysis, absolute benefit tended to be greater among women in TEXT who received chemotherapy (6.0%); intermediate among women in TEXT who did not receive chemotherapy (3.7%) and women in SOFT who received prior chemotherapy (3.7%); and less among women in SOFT who did not receive chemotherapy (1.9%).

Exemestane plus OFS was also superior to tamoxifen plus OFS in terms of breast cancer–free interval, with an absolute 4.1% benefit (P = .0002), and distant recurrence–free interval, with an absolute 2.1% benefit (P = .02). Overall survival did not differ significantly between arms.

Among the 86% of patients with HER2-negative disease, exemestane plus OFS netted an absolute disease-free survival gain of 5.4% and an absolute distant recurrence–free interval gain of 3.4%. There was a consistent relative treatment benefit across subgroups, but larger absolute benefit, on the order of 5%-9%, in women given chemotherapy and in those younger than 35 years.

“Results for the HER2-positive subgroup require further investigation,” Dr. Francis said. “The trials enrolled both before and after the routine use of adjuvant trastuzumab, and a significant proportion of the patients with HER2-positive breast cancer did not receive adjuvant HER2-targeted therapy.”

In the entire joint-analysis population, exemestane plus OFS was associated with higher rates of musculoskeletal events of grade 3 or 4 (11% vs. 6%) and osteoporosis of grade 2-4 (15% vs. 7%), while tamoxifen plus OFS was associated with a higher rate of thrombosis/embolism of grade 2-4 (2.3% vs. 1.2%) and more cases of endometrial cancer (9 vs. 4 cases). At 4 years, early discontinuation of oral endocrine therapy was greater for exemestane than for tamoxifen (25% vs. 19%).

“After longer follow-up, with a median of 9 years, the combined analysis results confirm a statistically significant improvement in disease outcomes with exemestane plus ovarian suppression. As is critical given the long natural history of estrogen receptor–positive breast cancer, follow-up in these trials is currently continuing,” Dr. Francis summarized.

“To optimally translate the observed absolute trial improvements into clinical practice, oncologists need to discuss and weigh the potential benefits and toxicities in each individual patient who is premenopausal with hormone receptor–positive breast cancer,” she recommended.

Session attendee Hope S. Rugo, MD, of the University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, noted that exemestane had superior benefit despite the 25% rate of early discontinuation. “I wonder if one of the interpretations of that, given the toxicity of this therapy for very young women, is that we need some but maybe not so much. Maybe they don’t need 5 years altogether,” she said.

“The fact that they stopped their assigned endocrine therapy doesn’t mean that they didn’t continue any therapy. They may have switched over to tamoxifen or they may have decided they wanted to have a baby or there may have been many other things,” Dr. Francis replied, noting that analyses sorting out the reasons for early discontinuation are planned.

Session attendee Mark E. Sherman, MD, of the Mayo Clinic, Jacksonville, Fla., asked, “Do you have any ability to test for tamoxifen metabolites? It’s possible that a third to a half of patients got reduced benefit from that drug.”

Banked samples are available and a substudy is planned, according to Dr. Francis. “We haven’t got data on that yet, but yes, we are analyzing that.”
 

SOFT update

Initial results of the SOFT trial, reported after a median follow-up of 5.6 years, showed that adding OFS to tamoxifen did not significantly improve disease-free survival over tamoxifen alone in the entire trial population (N Engl J Med. 2015;372:436-46). However, there was benefit for women who received chemotherapy and remained premenopausal.

The updated SOFT analysis, now with a median follow-up of 8 years, focused mainly on the 1,018 women given tamoxifen alone and the 1,015 women given tamoxifen plus OFS. (Another 1,014 women were given exemestane plus OFS.)

“SOFT is now positive for its primary endpoint,” reported first author Gini Fleming, MD, director of the Medical Oncology Breast Program and medical oncology director of Gynecologic Oncology at University of Chicago Medicine. The 8-year disease-free survival rate was 83.2% with tamoxifen plus OFS, compared with 78.9% with tamoxifen alone (HR, 0.76; P = .009), corresponding to a 4.2% gain in this outcome. The relative benefit was identical whether patients had received chemotherapy or not, but absolute benefit was greater for those who had (5.3%), as well as for patients younger than 35 years (8.7%).

In addition, exemestane plus OFS was superior to tamoxifen alone (85.9% vs. 78.9%; HR, 0.65), with an absolute benefit of 7.0%. Again, absolute benefit was more pronounced among women who had received prior chemotherapy (9.0%) or were younger than 35 years (13.1%).

The relative disease-free survival benefit of tamoxifen plus OFS over tamoxifen alone was similar across most subgroups stratified by disease characteristics, but patients with HER2-positive disease derived greater relative benefit from the combination as compared with their HER2-negative counterparts (P = .04 for interaction). “When we look at the combination of exemestane plus OFS versus tamoxifen, this heterogeneity is no longer seen,” Dr. Fleming noted.

In the entire trial population, there was no significant benefit of tamoxifen plus OFS over tamoxifen alone for distant recurrence-free interval and a small, significant absolute 1.9% gain in overall survival.

“The cohort who had elected to receive no prior chemotherapy did exceedingly well regardless of therapy,” she said, with little difference in overall survival across the three arms. “There were only 24 deaths total in this cohort, and 12 of those deaths were in the setting of no distant recurrence.”

On the other hand, among the women who received chemotherapy, there were significant absolute overall survival benefits of 4.3% with tamoxifen plus OFS and 2.1% with exemestane plus OFS, over tamoxifen alone. “This late emergence of an overall survival benefit is consistent with the time course of events in estrogen receptor–positive breast cancer,” Dr. Fleming commented.

The proportion of patients who stopped their oral endocrine therapy early was 22.5% with tamoxifen alone and 18.5% with tamoxifen plus OFS. (It was 27.8% with exemestane plus OFS.) “Almost a quarter of the patients on either tamoxifen arm were using extended oral endocrine therapy at 6 years or later prior to any disease progression. Only about 12% of patients in the exemestane group were doing so,” she noted.

There were more cases of endometrial cancer with tamoxifen alone than with tamoxifen plus OFS (7 vs. 4 cases). Thrombosis/embolism of grade 2-4 occurred in 2.2% of each group (and 0.9% of the exemestane plus OFS group). Musculoskeletal symptoms of grade 3 or 4 occurred in 6.7% of patients with tamoxifen alone and 5.9% with tamoxifen plus OFS, but 12.0% with exemestane plus OFS. Respective rates of osteoporosis grade 2-4 were 3.9%, 6.1%, and 11.9%.

“The addition of OFS to tamoxifen significantly improves disease-free survival at 8 years’ median follow-up, and disease-free survival benefits are further improved by the use of exemestane plus OFS,” Dr. Fleming summarized. “Follow-up, which is critically important given the long natural history of ER-positive disease, continues.”

Session attendee Matthew P. Goetz, MD, of the Mayo Clinic, Rochester, Minn., commented, “For the primary endpoint, I was looking at the tail for tamoxifen. It seemed that there was a relatively rapid drop-off between year 5 and this 8-year follow-up. Have you looked carefully to see whether there is a difference between those who stayed on their therapy versus those who went off it per protocol? That is, extended versus not extended? The question is whether there is a carry-over effect, if you will, that is different in those with OFS versus those not.”

“The percent who went on to extended therapy between the tamoxifen and the tamoxifen plus OFS was fairly similar,” Dr. Fleming replied. “But the answer is no, we have not yet done any sort of per protocol analysis.”

Session attendee Steven Vogl, MD, of Montefiore Medical Center, New York, commented, “I worry about your control group. I’m worried, first, how many of your tamoxifen patients lost their menses and became postmenopausal in those 5 years? And of those, why didn’t they switch to an aromatase inhibitor? Only 25% of the patients continued after the 5 years according to your slide, and all of those patients should either have stayed on tamoxifen or switched to an aromatase inhibitor, now probably for 2 years at least.”

“We have not yet looked at data for who became amenorrheic during treatment, although we have it. However, it’s certainly possible to become amenorrheic on tamoxifen and not be postmenopausal, and we didn’t regularly collect estradiol levels on any but the very small subset of women in the SOFT-S trial. So I don’t know that we have exactly the data that you’re looking for,” Dr. Fleming said. “Many of these women are obviously at very, very low risk and have done well with 5 years of tamoxifen alone, and I don’t know, even given current guidelines, that extended tamoxifen would add a lot to that.”

Finally, session attendee Richard Gray, professor of medical statistics at the University of Oxford (England), wondered, “What is the certainty that follow-up will happen? Because obviously, prolonged follow-up is expensive and there are controversies about that. But this would be the one study you would really want to have 15- and 20-year data on.”

“We are working very, very hard on that,” Dr. Fleming replied. “NCI granted additional funds to institutions for prolonging follow-up, and IBCSG has been ceaselessly working to look for funding to continue it. So I think it’s relatively certain that it will happen.”

Dr. Francis disclosed that she has received fees for non-CME services from AstraZeneca and has given an overseas lecture for Pfizer. Dr. Fleming disclosed that she had no relevant financial relationships with commercial interests. The trials received financial support from Pfizer and Ipsen.

SOURCES: Francis et al. SABCS Abstract GS4-02; Fleming et al. SABCS Abstract GS4-03
 

Gadolinium-based contrast agents (GBCAs) used for MRI will now carry a warning regarding their potential retention in the bodies and brains of treated patients, according to the Food and Drug Administration.

The FDA is requiring the new class warning, along with other safety measures, based on evidence showing that trace amounts of gadolinium can be retained in the body for months to years after treatment.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Specifically, the agency will require that patients receiving GBCAs first receive a Medication Guide and that GBCA manufacturers conduct human and animal studies to further assess GBCA safety. At this time, the only known adverse health effect of gadolinium retention is nephrogenic systemic fibrosis, which affects a small subgroup of patients with pre-existing kidney failure. No causal association has been established between gadolinium retention and reported adverse events in those with normal kidney function.

The FDA recommended that health care professionals consider the retention characteristics of GBCAs for patients who may be at higher risk for retention, including those requiring multiple lifetime doses, pregnant women, children, and patients with inflammatory conditions, but stressed that, although repeated GBCA imaging studies should be minimized when possible, they should not be avoided or deferred when they are necessary. In the safety alert, the FDA noted that administration of the GBCAs Dotarem (gadoterate meglumine), Gadavist (gadobutrol), and ProHance (gadoteridol) produce the lowest gadolinium levels in the body, and the three agents leave similar gadolinium levels in the body.

The agency encourages reports of adverse events or side effects related to the use of GBCAs to its MedWatch Safety information and Adverse Event Reporting Program. Reports can be submitted online at www.fda.gov/MedWatch/report or by calling 1-800-332-1088 to request a preaddressed form that can be mailed or faxed to 1-800-FDA-0178.

[email protected]

Gadolinium-based contrast agents (GBCAs) used for MRI will now carry a warning regarding their potential retention in the bodies and brains of treated patients, according to the Food and Drug Administration.

The FDA is requiring the new class warning, along with other safety measures, based on evidence showing that trace amounts of gadolinium can be retained in the body for months to years after treatment.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Specifically, the agency will require that patients receiving GBCAs first receive a Medication Guide and that GBCA manufacturers conduct human and animal studies to further assess GBCA safety. At this time, the only known adverse health effect of gadolinium retention is nephrogenic systemic fibrosis, which affects a small subgroup of patients with pre-existing kidney failure. No causal association has been established between gadolinium retention and reported adverse events in those with normal kidney function.

The FDA recommended that health care professionals consider the retention characteristics of GBCAs for patients who may be at higher risk for retention, including those requiring multiple lifetime doses, pregnant women, children, and patients with inflammatory conditions, but stressed that, although repeated GBCA imaging studies should be minimized when possible, they should not be avoided or deferred when they are necessary. In the safety alert, the FDA noted that administration of the GBCAs Dotarem (gadoterate meglumine), Gadavist (gadobutrol), and ProHance (gadoteridol) produce the lowest gadolinium levels in the body, and the three agents leave similar gadolinium levels in the body.

The agency encourages reports of adverse events or side effects related to the use of GBCAs to its MedWatch Safety information and Adverse Event Reporting Program. Reports can be submitted online at www.fda.gov/MedWatch/report or by calling 1-800-332-1088 to request a preaddressed form that can be mailed or faxed to 1-800-FDA-0178.

[email protected]

Gadolinium-based contrast agents (GBCAs) used for MRI will now carry a warning regarding their potential retention in the bodies and brains of treated patients, according to the Food and Drug Administration.

The FDA is requiring the new class warning, along with other safety measures, based on evidence showing that trace amounts of gadolinium can be retained in the body for months to years after treatment.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Specifically, the agency will require that patients receiving GBCAs first receive a Medication Guide and that GBCA manufacturers conduct human and animal studies to further assess GBCA safety. At this time, the only known adverse health effect of gadolinium retention is nephrogenic systemic fibrosis, which affects a small subgroup of patients with pre-existing kidney failure. No causal association has been established between gadolinium retention and reported adverse events in those with normal kidney function.

The FDA recommended that health care professionals consider the retention characteristics of GBCAs for patients who may be at higher risk for retention, including those requiring multiple lifetime doses, pregnant women, children, and patients with inflammatory conditions, but stressed that, although repeated GBCA imaging studies should be minimized when possible, they should not be avoided or deferred when they are necessary. In the safety alert, the FDA noted that administration of the GBCAs Dotarem (gadoterate meglumine), Gadavist (gadobutrol), and ProHance (gadoteridol) produce the lowest gadolinium levels in the body, and the three agents leave similar gadolinium levels in the body.

The agency encourages reports of adverse events or side effects related to the use of GBCAs to its MedWatch Safety information and Adverse Event Reporting Program. Reports can be submitted online at www.fda.gov/MedWatch/report or by calling 1-800-332-1088 to request a preaddressed form that can be mailed or faxed to 1-800-FDA-0178.

[email protected]

Gadolinium-based contrast agents (GBCAs) used for MRI will now carry a warning regarding their potential retention in the bodies and brains of treated patients, according to the Food and Drug Administration.

The FDA is requiring the new class warning, along with other safety measures, based on evidence showing that trace amounts of gadolinium can be retained in the body for months to years after treatment.

Wikimedia Commons/FitzColinGerald/Creative Commons License

[email protected]

Gadolinium-based contrast agents (GBCAs) used for MRI will now carry a warning regarding their potential retention in the bodies and brains of treated patients, according to the Food and Drug Administration.

The FDA is requiring the new class warning, along with other safety measures, based on evidence showing that trace amounts of gadolinium can be retained in the body for months to years after treatment.

Wikimedia Commons/FitzColinGerald/Creative Commons License

[email protected]

Gadolinium-based contrast agents (GBCAs) used for MRI will now carry a warning regarding their potential retention in the bodies and brains of treated patients, according to the Food and Drug Administration.

The FDA is requiring the new class warning, along with other safety measures, based on evidence showing that trace amounts of gadolinium can be retained in the body for months to years after treatment.

Wikimedia Commons/FitzColinGerald/Creative Commons License

[email protected]

For patients with cancer, acknowledgment of mental and emotional distress is critically important when developing and implementing a treatment plan. The psychosocial distress associated with cancer diagnosis and treatment can have an impact on a patient’s quality of life, influence a patient’s ability to adhere to treatment regimens, and increase cost of care.^1-4 Rates of depression have been reported to range from 8%-36%, with a 29% risk of anxiety in cancer patients.^{5, 6} Emotional distress is linked to increased hopelessness about their cancer diagnosis, increased issues with chronic pain, and negative treatment outcomes.⁷ Timely screening of psychosocial distress at the first clinical visit enables providers to make appropriate referrals to resources early in their course of treatment; however, referrals to psychosocial interventions remain infrequent nationwide in the United States.⁸

There is some evidence of a differential impact of cancer on mental health diagnoses between racial/ethnic groups; however, results are not entirely consistent across studies. Using the Kessler Pyschological Distress Scale (K6) score, Alcala and colleagues found that cancer was more detrimental to mental health for black patients than for non-Hispanic white patients.⁹ Black breast cancer survivors have also been shown to be more likely to stop working during the early phases of their treatment, indicating that they and their physicians need to take steps to minimize long-term employment consequences.¹⁰ However, in a study of women with breast cancer, black women reported fewer depressive symptoms than did non-Hispanic whites.¹¹

The American College of Surgeons’ Commission on Cancer (ACS CoC) developed a set of Continuum of Care standards in 2012, including the implementation of psychosocial distress screening for patients with cancer. Since 2015, all accredited cancer programs are now required to evaluate these patients for signs of distress during at least 1 pivotal physician visit.¹² The National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology has developed a tool that provides a mechanism for meeting the requirements of the ACS CoC accreditation requirements. The NCCN defines distress in cancer as “a multifactorial unpleasant emotional experience of a psychological (cognitive, behavioral, emotional), social, and/or spiritual nature that may interfere with the ability to cope effectively with cancer, its physical symptoms and its treatment.”¹³ The recommendation of the NCCN is to provide a brief screening for psychosocial distress to identify individuals in need of additional support and to provide referrals for patients at high risk of psychosocial distress. The NCCN Distress Thermometer screening tool has been widely accepted as an effective method of identifying and characterizing distress. The NCCN tool provides a visual analogue scale for patients to rate their current distress on a scale of 1-10, as well as a problem checklist. The problem checklist includes 22 stressors addressing the practical, spiritual/religious, emotional, and physical concerns of patients. Although the NCCN tool is used widely, differences in distress scores between black and white cancer patients have not been previously described. The purpose of the study was to compare the global distress screening scores of black and white patients at an academic comprehensive cancer center in the Midwest. A second objective was to examine the distribution of individual stressors between black and white women.
 

Methods

Study sample

The study included all cancer patients from a cancer center in the Midwest who completed the NCCN distress thermometer during January 1, 2015-February 19, 2016. The patient population for this cancer center was primarily non-Hispanic white and non-Hispanic black, therefore, only patients identifying as non-Hispanic white and non-Hispanic black are included in this analysis. As part of routine clinical care, patients are asked to complete the NCCN distress thermometer at their first visit to the center. All patients in this analytic sample were newly diagnosed patients. Some patients also completed the NCCN screening tool at additional appointments; therefore, for patients with more than 1 completed tool, only the first distress screening was used in this analysis. Overall scores and individual stressor scores were entered into the electronic medical record by clinic staff at the time the patients were roomed for their visit. Patient demographics were collected through a reporting mechanism within the electronic medical record that allows for monitoring of the psychosocial screening process.
 

Variables

Race was assessed through self-report and classified as non-Hispanic white and non-Hispanic black. There were not enough patients of any other racial/ethnic group to be included in this analysis. Age was categorized as 18-40 years, 41-60 years, 61-84 years, and 85 years and older. Cancer type was grouped as follows: head and neck cancer, gastrointestinal cancer (esophagus, stomach, small intestine, colon, rectum, anus), hepatobiliary (liver, gallbladder, pancreas), sarcoma (bone and soft tissue), melanoma, nonmelanoma skin cancer, breast cancer, genitourinary (prostate, kidney, bladder), hematologic, and brain.

Two primary outcomes were assessed: overall distress, and each individual problem indicator. Overall distress was assessed using the thermometer visual analog rating (the thermometer rating of the NCCN screening tool) where possible values range from 0 (no distress) to 10 (extreme distress). The overall distress score was categorized into low distress (<4) and high distress (≥4) for analysis. The response options for individual stressors on the problem list are Yes or No for each of 17 discrete stressors: child care, housing, insurance/financial, transportation, work/school, treatment decisions, dealing with children, dealing with partner, ability to have children, family health issues, depression, fears, nervousness, sadness, worry, loss of interest, and spiritual/religious concerns. Physical complaints were not assessed in this study. Comparisons were made between white and black patients on overall distress score as well as for each individual psychosocial stressor.
 

Data analysis

Descriptive statistics (counts and proportions or means and standard deviations) were calculated stratified by race. Categorical variables were compared by race using chi-square or Fisher exact test. Logistic regression was used to predict high distress by race adjusting for sex, age, and cancer type. All analyses were conducted using SAS 9.4 (Cary, NJ).

This study was reviewed and approved by the Saint Louis University Institutional Review Board (protocol number 26269).
 

Results

A total of 933 patients with cancer completed the NCCN distress screening tool. Of that total, 45 patients did not complete the overall distress score thermometer, but did complete the checklist of individual stressors. Those 45 patients were excluded from the logistic regression analysis for overall distress score, but included on comparisons of individual stressors. The distribution of overall distress scores by race can be seen in the Figure.

Table 2 presents bivariate comparisons on overall distress and individual stressors between black and white patients. There was no difference in the high distress between black and white patients in bivariate analysis (31.9% and 36.1%, respectively, P = .30). However, there were differences in the individual stressors identified for each racial group (Table 2). White patients, compared with black patients, more frequently identified treatment decisions (17.6% vs 10.1%, P = .02) and nervousness (26.8% vs 18.4%, P = .02) as sources of distress. Black patients, compared with white patients, more frequently identified housing (5.1% vs 1.7%, P = .009), the ability to have children (2.5% vs 0.4%, P =.02), and loss of interest (15.2% vs 8.9%, P = .02) as sources of distress. Distress scores did not differ between black and white patients for child care, insurance or financial issues, transportation, work or school, dealing with children, dealing with partners, family health issues, depression, fears, sadness, worry, or spiritual or religious concerns.

Discussion

Management of patients with cancer continues to evolve. Although a tremendous amount of importance is still placed on the pathophysiology of cancer and its prescribed treatments, more emphasis is being assigned to the physical and psychosocial effects of cancer on these patients. In 2008, the Institute of Medicine published a report that examined the psychosocial health of patients with cancer.¹⁴ The report recommended that all cancer care should ensure the provision of appropriate psychosocial health services by facilitating effective communication between patients and care providers, identifying each patient’s psychosocial health needs, coordinating referrals for psychosocial services and monitoring efficacy of psychosocial interventions. The inclusion of psychosocial distress screening in all cancer programs accredited by the ACS CoC helped to prioritize the identification and treatment of psychosocial issues for all cancer patients.

The present study is the first of its kind to compare the individual stressors identified through psychosocial distress screening between black and white cancer patients. In our sample, 304 of 933 patients (32%) reported high distress, with a total score of ≥4. Previous research on overall distress difference across race/ethnicity is mixed. VanHoose and colleagues found no difference in overall distress between racial groups,¹⁵ Alcala and colleagues found higher overall distress in black patients with cancer compared with white patients with cancer,⁹ and Culver and colleagues found black women with breast cancer had lower overall distress compared with white women.¹¹ We found no difference in the presence of high distress between black and white patients at our cancer center in either crude or adjusted analysis. Differences in overall distress across studies may be owing to the timing of screening. Given that overall distress may vary across time^16,17 and there is no current information on whether temporal variations in distress differ by race, it is possible that the time of distress assessment may influence demonstrated differences between racial groups. For example, if different stressors affect black and white women differentially, and those stressors are associated with different points across the cancer continuum, then we might see that the magnitude of racial differences in overall stress are time dependent. Alcala and colleagues examined any cancer diagnosis across the lifespan, whereas Culver and colleagues examined multiple time points across treatment for a small group of breast cancer patients. Badr and colleagues, in a sample of head and neck cancer patients, found that distress increased across the course of treatment;¹⁸ however they did not examine variations in type of stressors related to overall distress, nor did they examine racial differences in distress. Differences in results may also be the result of differences in measurement of distress. Culver and colleagues did not examine distress using the NCCN distress thermometer, rather psychological distress was measured by a scale rating a series of “mood-descriptive adjectives” (p. 497).¹¹ Alcala used the K-6 as a measure of psychological distress;⁹ therefore, demonstrated differences in overall distress between white and black women may vary across studies because of differences in measurement of the underlying distress variable. The lack of racial differences in overall distress in our study is consistent with the findings of VanHoose and colleagues,¹⁵ who also examined distress near the start of treatment and also used the NCCN distress thermometer as the measure of psychosocial distress.

We did find differences in the individual stressors between racial groups, indicating that the source of distress does vary between black and white cancer patients. Black patients more frequently reported distress secondary to housing, loss of interest and their ability to have children than did white patients. By comparison, white patients more frequently reported distress secondary to nervousness and treatment decisions than black patients. Identified differences in individual stressors may be attributable to sociocultural differences or differences in external support. It is also possible that black patients are more likely to willingly report distress related to nonpsychological factors, whereas white patients are more willing to report factors, such as nervousness, that are related to psychological disorders. Although it has been suggested that black cancer patients have more concerns about finances and work than do white cancer patients,¹⁹ we did not identify a statistically significant difference in child care, insurance or financial issues, transportation, work, or school between these 2 cohorts. This may be because the psychosocial distress screening score included in this study was performed at the time of initial diagnosis, and not further into their prescribed treatment at which point the financial worries may be more realized. Psychosocial screening scores obtained at subsequent visits were not included in the analysis because they are not routinely collected as part of clinical care in the center where this study took place. Furthermore, it is impossible to identify where a specific patient is in their treatment regimen based on their demographic data or subsequent distress scores in our data extraction tool. Further investigation into the sources of distress at different time points along the continuum of care may shed more light on this topic.
 

Limitations

There are several limitations to this study. First, the method of data extraction from an electronic medical record report limited the capacity to explore possible differences between the patients in our sample, such as insurance status, level of education, available social support, current employment status, stage of disease, overall prognosis and prescribed treatment regimen.

Second, there were likely patients who either did not complete a psychosocial distress screening tool or whose data were not entered into the electronic medical record for inclusion in the analysis. The present study period took place during the implementation of the NCCN tool at the center. Although the policy was to screen all new patients as part of routine care; not all patients seen at the center received the NCCN screening tool at their first visit. Owing to the mechanisms for data entry and abstraction, only information from the patients who had a completed form was able to be accessed for this study, thus a statistical comparison between those who did and did not receive the NCCN tool cannot be made. During the timeframe for this study, the head and neck, breast, genitourinary, and hematologic services completed proportionally more NCCN screening of new patients than other services in the center. This is reflected in the distributional breakdown of cancer in the overall sample of this study. It is possible that the results are more representative of differences between black and white cancer patients in the services that were more likely to properly implement NCCN screening.

Third, our patient population was derived from an urban, academic medical center and the results may not be generalizable to other patient populations.

Fourth, the NCCN distress thermometer is a single-item rating of overall global distress that is not intended to be a diagnostic indicator of psychological comorbidity and, therefore, does not distinguish between common psychological diagnoses such as depression or anxiety. However, the usefulness of the tool is to provide an impetus for referral to services that may then encompass the evaluation and diagnosis of particular psychological conditions. Further, the distress thermometer tool is designed to identify stress relating to the social aspects of cancer diagnosis and treatment and is not limited to psychological distress alone.
 

Strengths

Despite the limitations, there are also significant strengths to this study. The NCCN tool is a widely accepted measure for the assessment of psychosocial distress in patients with cancer. The measure is a common and routine clinical instrument,²⁰ and has also been used widely in research.^18,21-24 Given the urban, academic environment of our clinical practice, our population is more racially diverse than other settings, allowing for initial examination of disparities between white and black cancer patients.
 

Clinical implications

Understanding differences in common psychosocial stressor between black and white cancer patients may allow for clinicians to strategically look for different types of stressors in order to facilitate faster referrals to appropriate services. It has been established in the literature that distress is correlated to cancer-related outcomes and distress screening is now considered standard of care when treating cancer patients. Identifying differences in psychosocial stressors among black and white cancer patients is paramount to ensuring that the appropriate resources are available to assist them through their cancer journey. The differences in type of stressor, may indicate fundamental differences in the way patients perceive their disease or the social and cultural implication of a cancer diagnosis. In this study, white patients were more likely to find distress in the psychological realm (nervousness, decision-making), whereas black patients were more likely to be distressed about social issues (housing, ability to have children, and loss of interest). The referral needs of patients may be quite different, even with similar levels of overall distress. More research is necessary to further characterize sources of distress for cancer patients, how this distress impacts a patient’s physical and emotional well-being and how health care providers can better identify these issues and make the necessary referrals to support the whole patient.

For patients with cancer, acknowledgment of mental and emotional distress is critically important when developing and implementing a treatment plan. The psychosocial distress associated with cancer diagnosis and treatment can have an impact on a patient’s quality of life, influence a patient’s ability to adhere to treatment regimens, and increase cost of care.^1-4 Rates of depression have been reported to range from 8%-36%, with a 29% risk of anxiety in cancer patients.^{5, 6} Emotional distress is linked to increased hopelessness about their cancer diagnosis, increased issues with chronic pain, and negative treatment outcomes.⁷ Timely screening of psychosocial distress at the first clinical visit enables providers to make appropriate referrals to resources early in their course of treatment; however, referrals to psychosocial interventions remain infrequent nationwide in the United States.⁸

There is some evidence of a differential impact of cancer on mental health diagnoses between racial/ethnic groups; however, results are not entirely consistent across studies. Using the Kessler Pyschological Distress Scale (K6) score, Alcala and colleagues found that cancer was more detrimental to mental health for black patients than for non-Hispanic white patients.⁹ Black breast cancer survivors have also been shown to be more likely to stop working during the early phases of their treatment, indicating that they and their physicians need to take steps to minimize long-term employment consequences.¹⁰ However, in a study of women with breast cancer, black women reported fewer depressive symptoms than did non-Hispanic whites.¹¹

The American College of Surgeons’ Commission on Cancer (ACS CoC) developed a set of Continuum of Care standards in 2012, including the implementation of psychosocial distress screening for patients with cancer. Since 2015, all accredited cancer programs are now required to evaluate these patients for signs of distress during at least 1 pivotal physician visit.¹² The National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology has developed a tool that provides a mechanism for meeting the requirements of the ACS CoC accreditation requirements. The NCCN defines distress in cancer as “a multifactorial unpleasant emotional experience of a psychological (cognitive, behavioral, emotional), social, and/or spiritual nature that may interfere with the ability to cope effectively with cancer, its physical symptoms and its treatment.”¹³ The recommendation of the NCCN is to provide a brief screening for psychosocial distress to identify individuals in need of additional support and to provide referrals for patients at high risk of psychosocial distress. The NCCN Distress Thermometer screening tool has been widely accepted as an effective method of identifying and characterizing distress. The NCCN tool provides a visual analogue scale for patients to rate their current distress on a scale of 1-10, as well as a problem checklist. The problem checklist includes 22 stressors addressing the practical, spiritual/religious, emotional, and physical concerns of patients. Although the NCCN tool is used widely, differences in distress scores between black and white cancer patients have not been previously described. The purpose of the study was to compare the global distress screening scores of black and white patients at an academic comprehensive cancer center in the Midwest. A second objective was to examine the distribution of individual stressors between black and white women.
 

Methods

Study sample

The study included all cancer patients from a cancer center in the Midwest who completed the NCCN distress thermometer during January 1, 2015-February 19, 2016. The patient population for this cancer center was primarily non-Hispanic white and non-Hispanic black, therefore, only patients identifying as non-Hispanic white and non-Hispanic black are included in this analysis. As part of routine clinical care, patients are asked to complete the NCCN distress thermometer at their first visit to the center. All patients in this analytic sample were newly diagnosed patients. Some patients also completed the NCCN screening tool at additional appointments; therefore, for patients with more than 1 completed tool, only the first distress screening was used in this analysis. Overall scores and individual stressor scores were entered into the electronic medical record by clinic staff at the time the patients were roomed for their visit. Patient demographics were collected through a reporting mechanism within the electronic medical record that allows for monitoring of the psychosocial screening process.
 

Variables

Race was assessed through self-report and classified as non-Hispanic white and non-Hispanic black. There were not enough patients of any other racial/ethnic group to be included in this analysis. Age was categorized as 18-40 years, 41-60 years, 61-84 years, and 85 years and older. Cancer type was grouped as follows: head and neck cancer, gastrointestinal cancer (esophagus, stomach, small intestine, colon, rectum, anus), hepatobiliary (liver, gallbladder, pancreas), sarcoma (bone and soft tissue), melanoma, nonmelanoma skin cancer, breast cancer, genitourinary (prostate, kidney, bladder), hematologic, and brain.

Two primary outcomes were assessed: overall distress, and each individual problem indicator. Overall distress was assessed using the thermometer visual analog rating (the thermometer rating of the NCCN screening tool) where possible values range from 0 (no distress) to 10 (extreme distress). The overall distress score was categorized into low distress (<4) and high distress (≥4) for analysis. The response options for individual stressors on the problem list are Yes or No for each of 17 discrete stressors: child care, housing, insurance/financial, transportation, work/school, treatment decisions, dealing with children, dealing with partner, ability to have children, family health issues, depression, fears, nervousness, sadness, worry, loss of interest, and spiritual/religious concerns. Physical complaints were not assessed in this study. Comparisons were made between white and black patients on overall distress score as well as for each individual psychosocial stressor.
 

Data analysis

Descriptive statistics (counts and proportions or means and standard deviations) were calculated stratified by race. Categorical variables were compared by race using chi-square or Fisher exact test. Logistic regression was used to predict high distress by race adjusting for sex, age, and cancer type. All analyses were conducted using SAS 9.4 (Cary, NJ).

This study was reviewed and approved by the Saint Louis University Institutional Review Board (protocol number 26269).
 

Results

A total of 933 patients with cancer completed the NCCN distress screening tool. Of that total, 45 patients did not complete the overall distress score thermometer, but did complete the checklist of individual stressors. Those 45 patients were excluded from the logistic regression analysis for overall distress score, but included on comparisons of individual stressors. The distribution of overall distress scores by race can be seen in the Figure.

Table 2 presents bivariate comparisons on overall distress and individual stressors between black and white patients. There was no difference in the high distress between black and white patients in bivariate analysis (31.9% and 36.1%, respectively, P = .30). However, there were differences in the individual stressors identified for each racial group (Table 2). White patients, compared with black patients, more frequently identified treatment decisions (17.6% vs 10.1%, P = .02) and nervousness (26.8% vs 18.4%, P = .02) as sources of distress. Black patients, compared with white patients, more frequently identified housing (5.1% vs 1.7%, P = .009), the ability to have children (2.5% vs 0.4%, P =.02), and loss of interest (15.2% vs 8.9%, P = .02) as sources of distress. Distress scores did not differ between black and white patients for child care, insurance or financial issues, transportation, work or school, dealing with children, dealing with partners, family health issues, depression, fears, sadness, worry, or spiritual or religious concerns.

Discussion

Management of patients with cancer continues to evolve. Although a tremendous amount of importance is still placed on the pathophysiology of cancer and its prescribed treatments, more emphasis is being assigned to the physical and psychosocial effects of cancer on these patients. In 2008, the Institute of Medicine published a report that examined the psychosocial health of patients with cancer.¹⁴ The report recommended that all cancer care should ensure the provision of appropriate psychosocial health services by facilitating effective communication between patients and care providers, identifying each patient’s psychosocial health needs, coordinating referrals for psychosocial services and monitoring efficacy of psychosocial interventions. The inclusion of psychosocial distress screening in all cancer programs accredited by the ACS CoC helped to prioritize the identification and treatment of psychosocial issues for all cancer patients.

The present study is the first of its kind to compare the individual stressors identified through psychosocial distress screening between black and white cancer patients. In our sample, 304 of 933 patients (32%) reported high distress, with a total score of ≥4. Previous research on overall distress difference across race/ethnicity is mixed. VanHoose and colleagues found no difference in overall distress between racial groups,¹⁵ Alcala and colleagues found higher overall distress in black patients with cancer compared with white patients with cancer,⁹ and Culver and colleagues found black women with breast cancer had lower overall distress compared with white women.¹¹ We found no difference in the presence of high distress between black and white patients at our cancer center in either crude or adjusted analysis. Differences in overall distress across studies may be owing to the timing of screening. Given that overall distress may vary across time^16,17 and there is no current information on whether temporal variations in distress differ by race, it is possible that the time of distress assessment may influence demonstrated differences between racial groups. For example, if different stressors affect black and white women differentially, and those stressors are associated with different points across the cancer continuum, then we might see that the magnitude of racial differences in overall stress are time dependent. Alcala and colleagues examined any cancer diagnosis across the lifespan, whereas Culver and colleagues examined multiple time points across treatment for a small group of breast cancer patients. Badr and colleagues, in a sample of head and neck cancer patients, found that distress increased across the course of treatment;¹⁸ however they did not examine variations in type of stressors related to overall distress, nor did they examine racial differences in distress. Differences in results may also be the result of differences in measurement of distress. Culver and colleagues did not examine distress using the NCCN distress thermometer, rather psychological distress was measured by a scale rating a series of “mood-descriptive adjectives” (p. 497).¹¹ Alcala used the K-6 as a measure of psychological distress;⁹ therefore, demonstrated differences in overall distress between white and black women may vary across studies because of differences in measurement of the underlying distress variable. The lack of racial differences in overall distress in our study is consistent with the findings of VanHoose and colleagues,¹⁵ who also examined distress near the start of treatment and also used the NCCN distress thermometer as the measure of psychosocial distress.

We did find differences in the individual stressors between racial groups, indicating that the source of distress does vary between black and white cancer patients. Black patients more frequently reported distress secondary to housing, loss of interest and their ability to have children than did white patients. By comparison, white patients more frequently reported distress secondary to nervousness and treatment decisions than black patients. Identified differences in individual stressors may be attributable to sociocultural differences or differences in external support. It is also possible that black patients are more likely to willingly report distress related to nonpsychological factors, whereas white patients are more willing to report factors, such as nervousness, that are related to psychological disorders. Although it has been suggested that black cancer patients have more concerns about finances and work than do white cancer patients,¹⁹ we did not identify a statistically significant difference in child care, insurance or financial issues, transportation, work, or school between these 2 cohorts. This may be because the psychosocial distress screening score included in this study was performed at the time of initial diagnosis, and not further into their prescribed treatment at which point the financial worries may be more realized. Psychosocial screening scores obtained at subsequent visits were not included in the analysis because they are not routinely collected as part of clinical care in the center where this study took place. Furthermore, it is impossible to identify where a specific patient is in their treatment regimen based on their demographic data or subsequent distress scores in our data extraction tool. Further investigation into the sources of distress at different time points along the continuum of care may shed more light on this topic.
 

Limitations

There are several limitations to this study. First, the method of data extraction from an electronic medical record report limited the capacity to explore possible differences between the patients in our sample, such as insurance status, level of education, available social support, current employment status, stage of disease, overall prognosis and prescribed treatment regimen.

Second, there were likely patients who either did not complete a psychosocial distress screening tool or whose data were not entered into the electronic medical record for inclusion in the analysis. The present study period took place during the implementation of the NCCN tool at the center. Although the policy was to screen all new patients as part of routine care; not all patients seen at the center received the NCCN screening tool at their first visit. Owing to the mechanisms for data entry and abstraction, only information from the patients who had a completed form was able to be accessed for this study, thus a statistical comparison between those who did and did not receive the NCCN tool cannot be made. During the timeframe for this study, the head and neck, breast, genitourinary, and hematologic services completed proportionally more NCCN screening of new patients than other services in the center. This is reflected in the distributional breakdown of cancer in the overall sample of this study. It is possible that the results are more representative of differences between black and white cancer patients in the services that were more likely to properly implement NCCN screening.

Third, our patient population was derived from an urban, academic medical center and the results may not be generalizable to other patient populations.

Fourth, the NCCN distress thermometer is a single-item rating of overall global distress that is not intended to be a diagnostic indicator of psychological comorbidity and, therefore, does not distinguish between common psychological diagnoses such as depression or anxiety. However, the usefulness of the tool is to provide an impetus for referral to services that may then encompass the evaluation and diagnosis of particular psychological conditions. Further, the distress thermometer tool is designed to identify stress relating to the social aspects of cancer diagnosis and treatment and is not limited to psychological distress alone.
 

Strengths

Despite the limitations, there are also significant strengths to this study. The NCCN tool is a widely accepted measure for the assessment of psychosocial distress in patients with cancer. The measure is a common and routine clinical instrument,²⁰ and has also been used widely in research.^18,21-24 Given the urban, academic environment of our clinical practice, our population is more racially diverse than other settings, allowing for initial examination of disparities between white and black cancer patients.
 

Clinical implications

Understanding differences in common psychosocial stressor between black and white cancer patients may allow for clinicians to strategically look for different types of stressors in order to facilitate faster referrals to appropriate services. It has been established in the literature that distress is correlated to cancer-related outcomes and distress screening is now considered standard of care when treating cancer patients. Identifying differences in psychosocial stressors among black and white cancer patients is paramount to ensuring that the appropriate resources are available to assist them through their cancer journey. The differences in type of stressor, may indicate fundamental differences in the way patients perceive their disease or the social and cultural implication of a cancer diagnosis. In this study, white patients were more likely to find distress in the psychological realm (nervousness, decision-making), whereas black patients were more likely to be distressed about social issues (housing, ability to have children, and loss of interest). The referral needs of patients may be quite different, even with similar levels of overall distress. More research is necessary to further characterize sources of distress for cancer patients, how this distress impacts a patient’s physical and emotional well-being and how health care providers can better identify these issues and make the necessary referrals to support the whole patient.

For patients with cancer, acknowledgment of mental and emotional distress is critically important when developing and implementing a treatment plan. The psychosocial distress associated with cancer diagnosis and treatment can have an impact on a patient’s quality of life, influence a patient’s ability to adhere to treatment regimens, and increase cost of care.^1-4 Rates of depression have been reported to range from 8%-36%, with a 29% risk of anxiety in cancer patients.^{5, 6} Emotional distress is linked to increased hopelessness about their cancer diagnosis, increased issues with chronic pain, and negative treatment outcomes.⁷ Timely screening of psychosocial distress at the first clinical visit enables providers to make appropriate referrals to resources early in their course of treatment; however, referrals to psychosocial interventions remain infrequent nationwide in the United States.⁸

There is some evidence of a differential impact of cancer on mental health diagnoses between racial/ethnic groups; however, results are not entirely consistent across studies. Using the Kessler Pyschological Distress Scale (K6) score, Alcala and colleagues found that cancer was more detrimental to mental health for black patients than for non-Hispanic white patients.⁹ Black breast cancer survivors have also been shown to be more likely to stop working during the early phases of their treatment, indicating that they and their physicians need to take steps to minimize long-term employment consequences.¹⁰ However, in a study of women with breast cancer, black women reported fewer depressive symptoms than did non-Hispanic whites.¹¹

The American College of Surgeons’ Commission on Cancer (ACS CoC) developed a set of Continuum of Care standards in 2012, including the implementation of psychosocial distress screening for patients with cancer. Since 2015, all accredited cancer programs are now required to evaluate these patients for signs of distress during at least 1 pivotal physician visit.¹² The National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology has developed a tool that provides a mechanism for meeting the requirements of the ACS CoC accreditation requirements. The NCCN defines distress in cancer as “a multifactorial unpleasant emotional experience of a psychological (cognitive, behavioral, emotional), social, and/or spiritual nature that may interfere with the ability to cope effectively with cancer, its physical symptoms and its treatment.”¹³ The recommendation of the NCCN is to provide a brief screening for psychosocial distress to identify individuals in need of additional support and to provide referrals for patients at high risk of psychosocial distress. The NCCN Distress Thermometer screening tool has been widely accepted as an effective method of identifying and characterizing distress. The NCCN tool provides a visual analogue scale for patients to rate their current distress on a scale of 1-10, as well as a problem checklist. The problem checklist includes 22 stressors addressing the practical, spiritual/religious, emotional, and physical concerns of patients. Although the NCCN tool is used widely, differences in distress scores between black and white cancer patients have not been previously described. The purpose of the study was to compare the global distress screening scores of black and white patients at an academic comprehensive cancer center in the Midwest. A second objective was to examine the distribution of individual stressors between black and white women.
 

Methods

Study sample

The study included all cancer patients from a cancer center in the Midwest who completed the NCCN distress thermometer during January 1, 2015-February 19, 2016. The patient population for this cancer center was primarily non-Hispanic white and non-Hispanic black, therefore, only patients identifying as non-Hispanic white and non-Hispanic black are included in this analysis. As part of routine clinical care, patients are asked to complete the NCCN distress thermometer at their first visit to the center. All patients in this analytic sample were newly diagnosed patients. Some patients also completed the NCCN screening tool at additional appointments; therefore, for patients with more than 1 completed tool, only the first distress screening was used in this analysis. Overall scores and individual stressor scores were entered into the electronic medical record by clinic staff at the time the patients were roomed for their visit. Patient demographics were collected through a reporting mechanism within the electronic medical record that allows for monitoring of the psychosocial screening process.
 

Variables

Race was assessed through self-report and classified as non-Hispanic white and non-Hispanic black. There were not enough patients of any other racial/ethnic group to be included in this analysis. Age was categorized as 18-40 years, 41-60 years, 61-84 years, and 85 years and older. Cancer type was grouped as follows: head and neck cancer, gastrointestinal cancer (esophagus, stomach, small intestine, colon, rectum, anus), hepatobiliary (liver, gallbladder, pancreas), sarcoma (bone and soft tissue), melanoma, nonmelanoma skin cancer, breast cancer, genitourinary (prostate, kidney, bladder), hematologic, and brain.

Two primary outcomes were assessed: overall distress, and each individual problem indicator. Overall distress was assessed using the thermometer visual analog rating (the thermometer rating of the NCCN screening tool) where possible values range from 0 (no distress) to 10 (extreme distress). The overall distress score was categorized into low distress (<4) and high distress (≥4) for analysis. The response options for individual stressors on the problem list are Yes or No for each of 17 discrete stressors: child care, housing, insurance/financial, transportation, work/school, treatment decisions, dealing with children, dealing with partner, ability to have children, family health issues, depression, fears, nervousness, sadness, worry, loss of interest, and spiritual/religious concerns. Physical complaints were not assessed in this study. Comparisons were made between white and black patients on overall distress score as well as for each individual psychosocial stressor.
 

Data analysis

Descriptive statistics (counts and proportions or means and standard deviations) were calculated stratified by race. Categorical variables were compared by race using chi-square or Fisher exact test. Logistic regression was used to predict high distress by race adjusting for sex, age, and cancer type. All analyses were conducted using SAS 9.4 (Cary, NJ).

This study was reviewed and approved by the Saint Louis University Institutional Review Board (protocol number 26269).
 

Results

A total of 933 patients with cancer completed the NCCN distress screening tool. Of that total, 45 patients did not complete the overall distress score thermometer, but did complete the checklist of individual stressors. Those 45 patients were excluded from the logistic regression analysis for overall distress score, but included on comparisons of individual stressors. The distribution of overall distress scores by race can be seen in the Figure.

Table 2 presents bivariate comparisons on overall distress and individual stressors between black and white patients. There was no difference in the high distress between black and white patients in bivariate analysis (31.9% and 36.1%, respectively, P = .30). However, there were differences in the individual stressors identified for each racial group (Table 2). White patients, compared with black patients, more frequently identified treatment decisions (17.6% vs 10.1%, P = .02) and nervousness (26.8% vs 18.4%, P = .02) as sources of distress. Black patients, compared with white patients, more frequently identified housing (5.1% vs 1.7%, P = .009), the ability to have children (2.5% vs 0.4%, P =.02), and loss of interest (15.2% vs 8.9%, P = .02) as sources of distress. Distress scores did not differ between black and white patients for child care, insurance or financial issues, transportation, work or school, dealing with children, dealing with partners, family health issues, depression, fears, sadness, worry, or spiritual or religious concerns.

Discussion

Management of patients with cancer continues to evolve. Although a tremendous amount of importance is still placed on the pathophysiology of cancer and its prescribed treatments, more emphasis is being assigned to the physical and psychosocial effects of cancer on these patients. In 2008, the Institute of Medicine published a report that examined the psychosocial health of patients with cancer.¹⁴ The report recommended that all cancer care should ensure the provision of appropriate psychosocial health services by facilitating effective communication between patients and care providers, identifying each patient’s psychosocial health needs, coordinating referrals for psychosocial services and monitoring efficacy of psychosocial interventions. The inclusion of psychosocial distress screening in all cancer programs accredited by the ACS CoC helped to prioritize the identification and treatment of psychosocial issues for all cancer patients.

The present study is the first of its kind to compare the individual stressors identified through psychosocial distress screening between black and white cancer patients. In our sample, 304 of 933 patients (32%) reported high distress, with a total score of ≥4. Previous research on overall distress difference across race/ethnicity is mixed. VanHoose and colleagues found no difference in overall distress between racial groups,¹⁵ Alcala and colleagues found higher overall distress in black patients with cancer compared with white patients with cancer,⁹ and Culver and colleagues found black women with breast cancer had lower overall distress compared with white women.¹¹ We found no difference in the presence of high distress between black and white patients at our cancer center in either crude or adjusted analysis. Differences in overall distress across studies may be owing to the timing of screening. Given that overall distress may vary across time^16,17 and there is no current information on whether temporal variations in distress differ by race, it is possible that the time of distress assessment may influence demonstrated differences between racial groups. For example, if different stressors affect black and white women differentially, and those stressors are associated with different points across the cancer continuum, then we might see that the magnitude of racial differences in overall stress are time dependent. Alcala and colleagues examined any cancer diagnosis across the lifespan, whereas Culver and colleagues examined multiple time points across treatment for a small group of breast cancer patients. Badr and colleagues, in a sample of head and neck cancer patients, found that distress increased across the course of treatment;¹⁸ however they did not examine variations in type of stressors related to overall distress, nor did they examine racial differences in distress. Differences in results may also be the result of differences in measurement of distress. Culver and colleagues did not examine distress using the NCCN distress thermometer, rather psychological distress was measured by a scale rating a series of “mood-descriptive adjectives” (p. 497).¹¹ Alcala used the K-6 as a measure of psychological distress;⁹ therefore, demonstrated differences in overall distress between white and black women may vary across studies because of differences in measurement of the underlying distress variable. The lack of racial differences in overall distress in our study is consistent with the findings of VanHoose and colleagues,¹⁵ who also examined distress near the start of treatment and also used the NCCN distress thermometer as the measure of psychosocial distress.

We did find differences in the individual stressors between racial groups, indicating that the source of distress does vary between black and white cancer patients. Black patients more frequently reported distress secondary to housing, loss of interest and their ability to have children than did white patients. By comparison, white patients more frequently reported distress secondary to nervousness and treatment decisions than black patients. Identified differences in individual stressors may be attributable to sociocultural differences or differences in external support. It is also possible that black patients are more likely to willingly report distress related to nonpsychological factors, whereas white patients are more willing to report factors, such as nervousness, that are related to psychological disorders. Although it has been suggested that black cancer patients have more concerns about finances and work than do white cancer patients,¹⁹ we did not identify a statistically significant difference in child care, insurance or financial issues, transportation, work, or school between these 2 cohorts. This may be because the psychosocial distress screening score included in this study was performed at the time of initial diagnosis, and not further into their prescribed treatment at which point the financial worries may be more realized. Psychosocial screening scores obtained at subsequent visits were not included in the analysis because they are not routinely collected as part of clinical care in the center where this study took place. Furthermore, it is impossible to identify where a specific patient is in their treatment regimen based on their demographic data or subsequent distress scores in our data extraction tool. Further investigation into the sources of distress at different time points along the continuum of care may shed more light on this topic.
 

Limitations

There are several limitations to this study. First, the method of data extraction from an electronic medical record report limited the capacity to explore possible differences between the patients in our sample, such as insurance status, level of education, available social support, current employment status, stage of disease, overall prognosis and prescribed treatment regimen.

Second, there were likely patients who either did not complete a psychosocial distress screening tool or whose data were not entered into the electronic medical record for inclusion in the analysis. The present study period took place during the implementation of the NCCN tool at the center. Although the policy was to screen all new patients as part of routine care; not all patients seen at the center received the NCCN screening tool at their first visit. Owing to the mechanisms for data entry and abstraction, only information from the patients who had a completed form was able to be accessed for this study, thus a statistical comparison between those who did and did not receive the NCCN tool cannot be made. During the timeframe for this study, the head and neck, breast, genitourinary, and hematologic services completed proportionally more NCCN screening of new patients than other services in the center. This is reflected in the distributional breakdown of cancer in the overall sample of this study. It is possible that the results are more representative of differences between black and white cancer patients in the services that were more likely to properly implement NCCN screening.

Third, our patient population was derived from an urban, academic medical center and the results may not be generalizable to other patient populations.

Fourth, the NCCN distress thermometer is a single-item rating of overall global distress that is not intended to be a diagnostic indicator of psychological comorbidity and, therefore, does not distinguish between common psychological diagnoses such as depression or anxiety. However, the usefulness of the tool is to provide an impetus for referral to services that may then encompass the evaluation and diagnosis of particular psychological conditions. Further, the distress thermometer tool is designed to identify stress relating to the social aspects of cancer diagnosis and treatment and is not limited to psychological distress alone.
 

Strengths

Despite the limitations, there are also significant strengths to this study. The NCCN tool is a widely accepted measure for the assessment of psychosocial distress in patients with cancer. The measure is a common and routine clinical instrument,²⁰ and has also been used widely in research.^18,21-24 Given the urban, academic environment of our clinical practice, our population is more racially diverse than other settings, allowing for initial examination of disparities between white and black cancer patients.
 

Clinical implications

Understanding differences in common psychosocial stressor between black and white cancer patients may allow for clinicians to strategically look for different types of stressors in order to facilitate faster referrals to appropriate services. It has been established in the literature that distress is correlated to cancer-related outcomes and distress screening is now considered standard of care when treating cancer patients. Identifying differences in psychosocial stressors among black and white cancer patients is paramount to ensuring that the appropriate resources are available to assist them through their cancer journey. The differences in type of stressor, may indicate fundamental differences in the way patients perceive their disease or the social and cultural implication of a cancer diagnosis. In this study, white patients were more likely to find distress in the psychological realm (nervousness, decision-making), whereas black patients were more likely to be distressed about social issues (housing, ability to have children, and loss of interest). The referral needs of patients may be quite different, even with similar levels of overall distress. More research is necessary to further characterize sources of distress for cancer patients, how this distress impacts a patient’s physical and emotional well-being and how health care providers can better identify these issues and make the necessary referrals to support the whole patient.

Prostate cancer is the most common cancer among men and the second leading cause of cancer-related death in men. ¹ Treatment choices for prostate cancer are perhaps more varied than for many other cancers, with surgery, external beam radiation therapy, and brachytherapy all widely used, a number of adjuvant and nonstandard therapy options available, as well as the possibility of not immediately treating the cancer – the “active surveillance” option.

Biochemical failure rates do not differ between the 3 main treatments,² but each exposes patients to the risk of side effects, including impotence, incontinence, rectal injury, and operative mortality. Recovery can be gradual and will not always involve a return to baseline functioning.³ Quality-of-life comparisons observed covariate-controlled decreases in varying specific aspects of quality of life for each of the treatments.⁴

Surgery, brachytherapy, and external beam radiation therapy have each shown advantages over other treatments on at least some specific aspect, but disadvantages on others.⁴ Ongoing surveillance of a cancer left in place has become a more common option in part because of the disadvantages of traditional treatment and because of the growing recognition that sensitive diagnosis techniques often locate cancers that might not be life threatening. Recent reviews and reasonably long-term trials portray active surveillance as a valid alternative to surgery and radiation in many cases, with little difference in life expectancy and cancer-related quality of life, and possibly some reduction in health system cost.^5-7

Prostate cancer patients cope with these uncertainties and decisions in many ways,⁸ often using multiple coping behaviors,⁹ but coping almost always includes seeking information and social support, as well as active problem-solving, to make informed treatment decisions consistent with their values.

Unfortunately, prostate patients often do not receive or use needed information. McGregor¹⁰ reported that patients were aware of their incomplete understanding of their disease and treatment options. Findings from several studies suggest that patients often perceive that clinicians inform them about the disease and treatment options but then send them home unprepared to deal with such things as incontinence or difficulties with sexual functioning.¹¹

Similarly, previous research demonstrates the benefits of social support for prostate cancer patients who receive it, but also that overall they are underserved.^12,13 Male cancer patients are generally far less likely to seek support and health information than are female patients. And when patients with prostate cancer do participate in online cancer support groups, they are more likely to exchange information, whereas breast cancer patients provide support for each other.¹⁴

Mentoring

Some responses to these knowledge and support gaps pair newly diagnosed patients with survivors willing to be a guide, coach, and a source of information, as in the American Cancer Society’s (ACS’s) Man-to-Man support groups.¹⁵ Peer mentors may have a sophisticated level of understanding from their own experiences with medical literature and the health care system, but this cannot be assumed. Another mentoring model is expert-based, exemplified by the National Cancer Institute’s (NCI’s) cancer information specialist at the Cancer Information Service (CIS) and a similar system at the ACS. These telephone services allow for responsiveness to the caller’s needs, existing knowledge, and the caller’s readiness for information. The CIS specialist can also introduce important information the caller might not have known to ask about.¹⁶

However, not all problems presented by callers can be solved in a single conversation. Callers are encouraged to call back with additional questions or when their situation changes, but speaking with the same specialist is not facilitated, so it is hard for a second call to build upon the first. Combining the expertise of the cancer information specialist with the ongoing and proactive contact and support typical of the lay guide/mentor/navigator could be more effective. Here a CIS-trained information specialist called prostate patients multiple times over the intervention period to help them deal with information seeking and interpretation. In a previous study with breast cancer patients, a mentor of this sort improved patient information competence and emotional processing.¹⁷

Interactive resources

Online resources allow cancer patients self-paced and self-directed access to information and support anonymously and at any time. However, this can be more complicated than it might at first seem. With the complexities of the prostate cancer diagnosis, the multiple treatment options, and the uncertain but potentially serious effects of the treatments themselves, the amount of potentially relevant information is quite large. Then, because individuals will value differentially the attributes of treatments, their consequences, or even notions of risk and gain, a system must be able to respond appropriately to a range of very different people. Beyond this, as prostate cancer patients move from the shock of a cancer diagnosis to the problems of interpreting its details, to making treatment decisions, to dealing with problems of recovery, and then re-establishing what is a “new normal” for them, an individual’s demands on a system vary as well. Comprehensive and integrated systems of services meet the varying needs of their users at different times and different situations.^18,19 The systems approach not only makes it far easier for users to find what they need, it may also encourage them to see connections between physical, emotional, and social aspects of their illness. Versions of the system used in the present study – CHESS, or Comprehensive Health Enhancement Support System – have been effective supporting patients with AIDS and breast and lung cancers, and teens with asthma.^16,20

Study goals and hypotheses

Given the success of the 2 aforementioned approaches, we wanted to compare how CHESS and ongoing contact with a human cancer information mentor in patients with prostate cancer would affect both several general aspects of quality of life and 1 specific to prostate cancer. We also examined differences in the patients’ information competence, quality of life, and social support. There was no a priori expectation that one intervention would be superior to the other, but any differences found could be important to policy decisions, given their quite-different cost and scalability.

More importantly, the primary hypothesis of the study was that patients with access to both CHESS and a mentor would experience substantially better outcomes than those with access to either intervention alone, because each had the potential to enhance the other’s benefits. For example, a patient could read CHESS material and come to the mentor much better prepared. By referring the user to specific parts of CHESS for basic information, the mentor could use calls to address more complex issues, or help interpret and evaluate difficult issues. In addition, because CHESS provides the mentor information about changes in the patient’s treatments, symptoms, and CHESS use, in the combined condition the cancer information mentor can know much more about the patient than when working alone. We also expected that the mentor would stimulate the kind of diverse use of CHESS services we have found to be most effective for improving quality of life.²¹ A previous study of CHESS for women with breast cancer concluded that a combined condition benefitted patients more than either CHESS or a cancer mentor alone,¹⁷ and we sought to determine whether we would have similar results with men with prostate cancer.

Because both mentoring and CHESS have consistently produced positive quality of life effects on their own, compared to controls, there is no reasonable expectation that negative effects of a combined condition could occur and should be tested for. Thus, the study was powered for 1-tailed significance in the comparison between the combined condition and either intervention alone, a procedure used consistently in previous studies of CHESS components or combined conditions. However, since the research question comparing the 2 interventions alone had no such strong history it was tested 2-tailed.
 

Methods

Recruitment

Study recruitment was conducted from January 1, 2007 to September 30, 2008 at the University of Wisconsin’s Paul P Carbone Comprehensive Cancer Center in Madison, Hartford Hospital’s Helen and Harry Gray Cancer Center in Hartford, Connecticut, and The University of Texas MD Anderson Cancer Center in Houston.

A total of 461 patients were invited to participate in the study. Of those patients, 147 declined to participate, 4 were excluded, and 310 were randomized to access to CHESS only, access to a human mentor only, or access to CHESS and a mentor (CHESS+Mentor) during the 6-month intervention period, which provided adequate power (>.80) for effects of moderate size (Figure 1). Randomization was done with a computer-generated list that site study managers accessed on a patient-by-patient basis, with experimental conditions blocked within sites.

Interventions

To provide an equal baseline, all of the participants were given access to the Internet, which is becoming a de facto standard for information access. Internet access charges were paid for all participants during the 6-month intervention period, and computers were loaned to those who did not have a personal computer. All of the participants were offered training on using the computer, particularly with Google search procedures so that they could access resources on prostate cancer.

Participants assigned to the CHESS or CHESS+Mentor conditions were also offered training in using CHESS (basically a guided tour), which typically took about 30 minutes on the telephone but was occasionally done in-person.

CHESS intervention. In creating CHESS for prostate cancer patients, a combination of patient needs assessments, focus groups with patients and family members, and clinician expertise helped us identify the needs, coping mechanisms, and relevant medical information to help patients respond to the disease. An article describing development of the CHESS Prostate Cancer Module²² presents how those different services address patient needs for information, communication, and support, or build skills.

Most of these services were present in CHESS for other diseases, but several were newly created to meet needs of prostate cancer patients and partners, such as a decision map tool and a module on managing sexual problems.²² Also, patients expressed frustration at being overwhelmed by the volume of information and said they would prefer to focus only on what was most relevant, so we created an alternative navigation structure on the CHESS homepage. Using terms suggested by focus groups of prostate cancer survivors and their spouses, we devised a navigation structure called Step-by-Step that identified 6 typical sequential steps of men’s experience with prostate cancer. Clicking on a step would take a patient to a menu focused on actions and considerations specific to that disease step, links to information most relevant at that step, and suggested questions to ask oneself and one’s doctor.

Mentor intervention. The cancer information mentor who made most of the calls to patients was an experienced information specialist with the Cancer Information Service and had served as the expert for the CHESS Ask an Expert service for 6 years. She was highly knowledgeable about prostate cancer and patient information needs. Her additional training for this study focused on taking advantage of repeated contacts with the participants and how to set limits to avoid any semblance of psychological counseling. At recruitment, we made clear that a male mentor was also available if the participant would prefer to discuss sensitive topics with another man. The male mentor was experienced in the Man-to-Man program and received additional training for this role, but he was used for only 1% of all contacts.

During calls, the mentor had Internet access to a range of NCI, ACS, and other resources. She could help interpret information the participant already possessed as well as refer him to other public resources, including those on the Internet. CHESS software designers created an additional interface for the mentor that handled call scheduling and allowed her to record the topics of conversations, her responses and recommendations, and her overall ratings of patient preparedness and satisfaction. Using this interface allowed the mentor to quickly review a participant’s status and focus the conversation on issues raised by past conversations or scheduled treatment events. The mentor calls were audiorecorded and reviewed frequently by the project director during the early months of intervention and less frequently thereafter to ensure adherence to the protocol.

The mentor telephoned weekly during the first month of intervention, then twice during the second month, and once a month during the final 4 months of the intervention (ie, 10 scheduled calls, though patients could also initiate additional calls). Calls were scheduled through a combination of telephone contact and e-mail according to the patient’s preference. Call length ranged from 5 minutes to an hour, with the average about 12 minutes (the first call tended to be considerably longer, and was scheduled for 45 minutes). About 10%-15% of participants in the Mentor conditions initiated calls to the mentor to obtain additional support, and about 15% of scheduled calls in fact took place as e-mail exchanges. A few calls were missed because of scheduling difficulties, and some participants stopped scheduling the last few calls, but the average number of full calls or e-mails was 6.41 per participant.

CHESS+Mentor intervention. For the CHESS+Mentor condition, the interactions and resources used were similar to those of the Mentor-only condition, but the interface also provided the mentor with a summary of the participant’s recent CHESS use and any concerns reported to CHESS, which helped the mentor assess knowledge and make tailored recommendations. The mentor could also refer participants to specific resources within CHESS, aided by knowledge of what parts of CHESS had or had not been used.

Assessment methods

Patients were given surveys at the baseline visit to complete and mail back to research staff before randomization. Follow-up surveys were mailed to patients at 2, 6, 12, and 24 weeks post intervention access, and patients returned the surveys by mail. Patient withdrawal rates were about 3%.

Measures

Outcomes. This study included 4 measures of quality of life (an average of relevant portions of the World Health Organization’s Quality of Life (WHOQOL) measure, Emotional and Functional Well-being, and a prostate-cancer specific index, the Expanded Prostate Cancer Index Composite (EPIC). We also tested group differences on 5 more specific outcomes that were likely to be proximal rather than distal effects of the interventions: Cancer Information Competence, Health care Competence, Social Support, Bonding (with other patients), and Positive Coping.



Quality of life. Quality of life was measured by combining the psychological, social, and overall dimensions of the WHOQOL measures.²³ Each of the 11 items was assessed with a 5-point scale, and the mean of those answers was the overall score.



Emotional well-being. Respondents answered 6 items of the Functional Assessment of Cancer Therapy – Prostate (FACT-P)²⁴ describing emotional aspects of reactions to cancer.



Functional well-being. Respondents indicated how often they experienced each of the seven functional well-being subscale items of the FACT-Prostate.²⁴



Prostate cancer patient functioning. We used the EPIC to measure of 3 of 4 domains of prostate cancer patient functioning: urinary, bowel, and sexual (omitting hormonal).²⁵ The EPIC measures frequency and subjective degree of being a problem of several aspects in each domain. We then summed scores across the domains and transformed linearly to a 0-100 scale, with higher scores representing better functioning.



Cancer information competence. Five cancer information competence items, measured on a 5-point scale, assessed a participant’s perception about whether he could find and effectively and use health information, and were summed to create a single score.²⁰



Social support. Six 5-point social support items assessed the informational and emotional support provided by friends, family, coworkers, and others, and were summed to create a single score.²⁰



Health care competence. Five 5-point health care competence items assessed a patient’s comfort and activation level dealing with physicians and health care situations, and were summed to create a single score.²⁰



Positive coping. Coping strategies were measured with the Brief Cope, a shorter version of the original 60-item COPE scale.²⁶ Positive coping strategy, a predictor of positive adaptation in numerous coping contexts, was measured with the mean score of 4 scales (8 items in all): active coping, planning, positive reframing, and humor.



Bonding. Bonding with other prostate cancer patients was measured with five 5-point items about how frequently participants connected with and got information and support from other men with prostate cancer.²⁷



User vs nonuser. Intent-to-treat analyses compared the assigned conditions. However, because CHESS use was self-selected and available at any time whereas mentor calls were scheduled and initiated by another person, the proportion actually using the interventions was quite different.

Since a participant assigned access to CHESS had to select the URL, even a single entry to the system was counted as use. Of 198 participants assigned to either the CHESS or CHESS+Mentor conditions, 43 (22%) never logged in and were classified as nonusers.

Because the mentor scheduled calls and attempted repeatedly to complete scheduled calls, the patient was in a reactive position, and the decision not to use the mentor’s services could come at the earliest at the end of a first completed call. However, after examining call notes and consulting with the mentors, it was clear that opting not to receive mentoring typically occurred at the second call. Furthermore, much (though not all) of the first call was typically taken up with getting acquainted and scheduling issues, so that defining “nonuse” as 2 or fewer completed calls was most faithful to what actually happened. Of 202 participants assigned access to a mentor, 16 (8%) were thus defined as nonusers.

Results

Overall, the participants were about 60 years of age and had some college education and middle-class incomes (Table 1). Only about 10% were minorities or lived alone, and their comfort using computers and the Internet was at or above the “quite comfortable” level. None of groups differed significantly from any other.

The 2 primary hypotheses of the study were that participants in the combined condition would manifest higher outcome scores than those with either intervention alone. Table 2 displays group means at 3 posttest intervals, controlling for theoretically chosen covariates (age, education, and minority status) and pretest levels of the dependent variable. The table also summarizes tests examining the hypotheses and the comparison of CHESS and Mentor conditions. The 4 quality-of-life scores appear first, followed by 5 more specific outcomes that are perhaps more proximal effects of these interventions.

Discussion

We used a randomized control design to test whether combining computer-based and human interventions would provide greater benefits to prostate cancer patients than either alone, as previous research had shown for breast cancer patients.¹⁸ The computer-based resource was CHESS, a repeatedly evaluated integrated system combining information, social support, and interactive tools to help patients manage their response to disease. The human cancer information mentor intervention combined the expertise of NCI’s Cancer Information Service with the repeated contact more typical of peer mentoring. Previous research with breast cancer patients had shown both interventions to provide greater information, support, and quality-of-life benefits than Internet access alone.¹⁴ This study also compared outcomes obtained by the separate CHESS and Mentor conditions, but without predicting a direction of difference.

Tests at 6 weeks, 3 months and 6 months after intervention found instances in which prostate cancer patients assigned to the combined CHESS+Mentor condition experienced more positive quality of life or other outcomes than those assigned to CHESS or Mentor alone, but those differences were scattered rather than consistent. In the direct comparisons of the separate CHESS and Mentor conditions, significance was even rarer, but outcome scores tended to be higher in the Mentor condition than in the CHESS condition.

We noted that differential uptake of the 2 interventions (92% for Mentor vs 78% for CHESS) made interpreting the intent-to-treat analyses problematic, as the mentor’s control of the call schedule meant that far more patients in that condition actually received at least some intervention than in the CHESS condition, where patients used or did not use CHESS entirely at their own volition. This could have biased results in several ways, such as by underestimating the efficacy of the CHESS condition alone and thus inflating the contrast between CHESS alone and CHESS+Mentor. Or the combined condition might have been less different than the Mentor-only condition than intended, thus making for a conservative test of that comparison. However, post hoc analyses of only those participants who had actually used their assigned interventions (and this led to some reclassification of those originally assigned to the CHESS+Mentor condition) produced results that were little different than the intent-to-treat analysis.

Thus, although the combined condition produced some small advantages over either intervention alone, these advantages did not live up to expectations or to previous experience with breast cancer patients.¹⁷ We expected the mentor to be able to reinforce and help interpret what the participants learned from CHESS and their clinicians, and also to advise and direct these patients to be much more effective users of CHESS and other resources. Similarly, we expected that CHESS would make patients much better prepared for mentoring, so that instead of dealing with routine information matters, the mentor could go into greater detail or deal with more complex issues. Their combined effect should have been much larger than each alone, and that was not the case. Perhaps from the prostate cancer patients’ perspective, the 2 interventions seemed to offer similar resources, and a patient benefitted from one or the other but expected no additional gain from attending to both.

The 2 interventions themselves seemed nearly equally effective. The Mentor intervention was significantly stronger than CHESS in only 1 of 27 tests in the intent-to-treat analysis and 2 in the analysis limited to intervention users.

These results for prostate cancer patients are somewhat weaker than those previously reported with breast cancer patients.¹⁷ It is possible that prostate cancer patients (or men in general) are less inclined to seek health information, support, and health self-management than breast cancer patients (or women in general), perhaps because many men perceive decision-making to end with initial treatment, whereas women typically deal with follow-up treatments as well. Use of CHESS and the mentor was modestly lower for the men here than for the women in the previous studies. It is also possible that the CHESS Prostate Cancer module was not as good as the Breast Cancer module, although we are doubtful of that, given the additional tools and improvements added here in response to quite good focus group participants.²²It may also be true that as time goes on, the relative advantage of these interventions over support generally available over the Internet is simply waning – other websites are getting richer and more sophisticated, and users are getting better at searching them out (and avoiding weak or commercially motivated sites).

Although these interventions were experienced by prostate cancer patients in their homes in natural and familiar ways, any experimental manipulation must acknowledge possible problems with external validity. More important here, our recruitment procedures may have produced self-selection to enter or not enter the study in 2 ways that limit its applicability. First, although we thought that offering Internet access to all participants would make participation more likely, the most frequent reason men gave in declining to join the study was “not a computer person.” Our participants were certainly very comfortable with computers and the Internet, and most used them frequently even before the study. Second, it seems that, except for their prostate cancer, our sample was healthy in other respects, as indicated by the low number of other health care visits or surgeries/hospitalization they reported (and “overwhelmed” and “too busy,” 2 common reasons for declining study participations could also be coming from men with more comorbidities). Thus, our sample was probably more computer literate and healthier than the general population of prostate cancer patients.

Nonetheless, for policymakers deciding what information and support interventions to put in place for prostate cancer patients (or more generally for other cancer patients as well), these results have 2 implications. First, since the combination of the mentor and CHESS produced only small advantages over either alone, the extra effort of doing both seems clearly unwarranted for prostate cancer patients. The somewhat larger advantage of the combined intervention shown for breast cancer patients in previous studiesmight warrant using the combination in some circumstances, but even that is not clear-cut.

Finding that CHESS and the cancer information mentor separately provided essentially equal benefits might seem to suggest that they can be regarded as alternatives. However, computer-based services can be provided much more cheaply and scaled up far more readily than services dependent on one-on-one contacts by a highly trained professional. This may direct health care decision makers first toward computer-based services.

Prostate cancer is the most common cancer among men and the second leading cause of cancer-related death in men. ¹ Treatment choices for prostate cancer are perhaps more varied than for many other cancers, with surgery, external beam radiation therapy, and brachytherapy all widely used, a number of adjuvant and nonstandard therapy options available, as well as the possibility of not immediately treating the cancer – the “active surveillance” option.

Biochemical failure rates do not differ between the 3 main treatments,² but each exposes patients to the risk of side effects, including impotence, incontinence, rectal injury, and operative mortality. Recovery can be gradual and will not always involve a return to baseline functioning.³ Quality-of-life comparisons observed covariate-controlled decreases in varying specific aspects of quality of life for each of the treatments.⁴

Surgery, brachytherapy, and external beam radiation therapy have each shown advantages over other treatments on at least some specific aspect, but disadvantages on others.⁴ Ongoing surveillance of a cancer left in place has become a more common option in part because of the disadvantages of traditional treatment and because of the growing recognition that sensitive diagnosis techniques often locate cancers that might not be life threatening. Recent reviews and reasonably long-term trials portray active surveillance as a valid alternative to surgery and radiation in many cases, with little difference in life expectancy and cancer-related quality of life, and possibly some reduction in health system cost.^5-7

Prostate cancer patients cope with these uncertainties and decisions in many ways,⁸ often using multiple coping behaviors,⁹ but coping almost always includes seeking information and social support, as well as active problem-solving, to make informed treatment decisions consistent with their values.

Unfortunately, prostate patients often do not receive or use needed information. McGregor¹⁰ reported that patients were aware of their incomplete understanding of their disease and treatment options. Findings from several studies suggest that patients often perceive that clinicians inform them about the disease and treatment options but then send them home unprepared to deal with such things as incontinence or difficulties with sexual functioning.¹¹

Similarly, previous research demonstrates the benefits of social support for prostate cancer patients who receive it, but also that overall they are underserved.^12,13 Male cancer patients are generally far less likely to seek support and health information than are female patients. And when patients with prostate cancer do participate in online cancer support groups, they are more likely to exchange information, whereas breast cancer patients provide support for each other.¹⁴

Mentoring

Some responses to these knowledge and support gaps pair newly diagnosed patients with survivors willing to be a guide, coach, and a source of information, as in the American Cancer Society’s (ACS’s) Man-to-Man support groups.¹⁵ Peer mentors may have a sophisticated level of understanding from their own experiences with medical literature and the health care system, but this cannot be assumed. Another mentoring model is expert-based, exemplified by the National Cancer Institute’s (NCI’s) cancer information specialist at the Cancer Information Service (CIS) and a similar system at the ACS. These telephone services allow for responsiveness to the caller’s needs, existing knowledge, and the caller’s readiness for information. The CIS specialist can also introduce important information the caller might not have known to ask about.¹⁶

However, not all problems presented by callers can be solved in a single conversation. Callers are encouraged to call back with additional questions or when their situation changes, but speaking with the same specialist is not facilitated, so it is hard for a second call to build upon the first. Combining the expertise of the cancer information specialist with the ongoing and proactive contact and support typical of the lay guide/mentor/navigator could be more effective. Here a CIS-trained information specialist called prostate patients multiple times over the intervention period to help them deal with information seeking and interpretation. In a previous study with breast cancer patients, a mentor of this sort improved patient information competence and emotional processing.¹⁷

Interactive resources

Online resources allow cancer patients self-paced and self-directed access to information and support anonymously and at any time. However, this can be more complicated than it might at first seem. With the complexities of the prostate cancer diagnosis, the multiple treatment options, and the uncertain but potentially serious effects of the treatments themselves, the amount of potentially relevant information is quite large. Then, because individuals will value differentially the attributes of treatments, their consequences, or even notions of risk and gain, a system must be able to respond appropriately to a range of very different people. Beyond this, as prostate cancer patients move from the shock of a cancer diagnosis to the problems of interpreting its details, to making treatment decisions, to dealing with problems of recovery, and then re-establishing what is a “new normal” for them, an individual’s demands on a system vary as well. Comprehensive and integrated systems of services meet the varying needs of their users at different times and different situations.^18,19 The systems approach not only makes it far easier for users to find what they need, it may also encourage them to see connections between physical, emotional, and social aspects of their illness. Versions of the system used in the present study – CHESS, or Comprehensive Health Enhancement Support System – have been effective supporting patients with AIDS and breast and lung cancers, and teens with asthma.^16,20

Study goals and hypotheses

Given the success of the 2 aforementioned approaches, we wanted to compare how CHESS and ongoing contact with a human cancer information mentor in patients with prostate cancer would affect both several general aspects of quality of life and 1 specific to prostate cancer. We also examined differences in the patients’ information competence, quality of life, and social support. There was no a priori expectation that one intervention would be superior to the other, but any differences found could be important to policy decisions, given their quite-different cost and scalability.

More importantly, the primary hypothesis of the study was that patients with access to both CHESS and a mentor would experience substantially better outcomes than those with access to either intervention alone, because each had the potential to enhance the other’s benefits. For example, a patient could read CHESS material and come to the mentor much better prepared. By referring the user to specific parts of CHESS for basic information, the mentor could use calls to address more complex issues, or help interpret and evaluate difficult issues. In addition, because CHESS provides the mentor information about changes in the patient’s treatments, symptoms, and CHESS use, in the combined condition the cancer information mentor can know much more about the patient than when working alone. We also expected that the mentor would stimulate the kind of diverse use of CHESS services we have found to be most effective for improving quality of life.²¹ A previous study of CHESS for women with breast cancer concluded that a combined condition benefitted patients more than either CHESS or a cancer mentor alone,¹⁷ and we sought to determine whether we would have similar results with men with prostate cancer.

Because both mentoring and CHESS have consistently produced positive quality of life effects on their own, compared to controls, there is no reasonable expectation that negative effects of a combined condition could occur and should be tested for. Thus, the study was powered for 1-tailed significance in the comparison between the combined condition and either intervention alone, a procedure used consistently in previous studies of CHESS components or combined conditions. However, since the research question comparing the 2 interventions alone had no such strong history it was tested 2-tailed.
 

Methods

Recruitment

Study recruitment was conducted from January 1, 2007 to September 30, 2008 at the University of Wisconsin’s Paul P Carbone Comprehensive Cancer Center in Madison, Hartford Hospital’s Helen and Harry Gray Cancer Center in Hartford, Connecticut, and The University of Texas MD Anderson Cancer Center in Houston.

A total of 461 patients were invited to participate in the study. Of those patients, 147 declined to participate, 4 were excluded, and 310 were randomized to access to CHESS only, access to a human mentor only, or access to CHESS and a mentor (CHESS+Mentor) during the 6-month intervention period, which provided adequate power (>.80) for effects of moderate size (Figure 1). Randomization was done with a computer-generated list that site study managers accessed on a patient-by-patient basis, with experimental conditions blocked within sites.

Interventions

To provide an equal baseline, all of the participants were given access to the Internet, which is becoming a de facto standard for information access. Internet access charges were paid for all participants during the 6-month intervention period, and computers were loaned to those who did not have a personal computer. All of the participants were offered training on using the computer, particularly with Google search procedures so that they could access resources on prostate cancer.

Participants assigned to the CHESS or CHESS+Mentor conditions were also offered training in using CHESS (basically a guided tour), which typically took about 30 minutes on the telephone but was occasionally done in-person.

CHESS intervention. In creating CHESS for prostate cancer patients, a combination of patient needs assessments, focus groups with patients and family members, and clinician expertise helped us identify the needs, coping mechanisms, and relevant medical information to help patients respond to the disease. An article describing development of the CHESS Prostate Cancer Module²² presents how those different services address patient needs for information, communication, and support, or build skills.

Most of these services were present in CHESS for other diseases, but several were newly created to meet needs of prostate cancer patients and partners, such as a decision map tool and a module on managing sexual problems.²² Also, patients expressed frustration at being overwhelmed by the volume of information and said they would prefer to focus only on what was most relevant, so we created an alternative navigation structure on the CHESS homepage. Using terms suggested by focus groups of prostate cancer survivors and their spouses, we devised a navigation structure called Step-by-Step that identified 6 typical sequential steps of men’s experience with prostate cancer. Clicking on a step would take a patient to a menu focused on actions and considerations specific to that disease step, links to information most relevant at that step, and suggested questions to ask oneself and one’s doctor.

Mentor intervention. The cancer information mentor who made most of the calls to patients was an experienced information specialist with the Cancer Information Service and had served as the expert for the CHESS Ask an Expert service for 6 years. She was highly knowledgeable about prostate cancer and patient information needs. Her additional training for this study focused on taking advantage of repeated contacts with the participants and how to set limits to avoid any semblance of psychological counseling. At recruitment, we made clear that a male mentor was also available if the participant would prefer to discuss sensitive topics with another man. The male mentor was experienced in the Man-to-Man program and received additional training for this role, but he was used for only 1% of all contacts.

During calls, the mentor had Internet access to a range of NCI, ACS, and other resources. She could help interpret information the participant already possessed as well as refer him to other public resources, including those on the Internet. CHESS software designers created an additional interface for the mentor that handled call scheduling and allowed her to record the topics of conversations, her responses and recommendations, and her overall ratings of patient preparedness and satisfaction. Using this interface allowed the mentor to quickly review a participant’s status and focus the conversation on issues raised by past conversations or scheduled treatment events. The mentor calls were audiorecorded and reviewed frequently by the project director during the early months of intervention and less frequently thereafter to ensure adherence to the protocol.

The mentor telephoned weekly during the first month of intervention, then twice during the second month, and once a month during the final 4 months of the intervention (ie, 10 scheduled calls, though patients could also initiate additional calls). Calls were scheduled through a combination of telephone contact and e-mail according to the patient’s preference. Call length ranged from 5 minutes to an hour, with the average about 12 minutes (the first call tended to be considerably longer, and was scheduled for 45 minutes). About 10%-15% of participants in the Mentor conditions initiated calls to the mentor to obtain additional support, and about 15% of scheduled calls in fact took place as e-mail exchanges. A few calls were missed because of scheduling difficulties, and some participants stopped scheduling the last few calls, but the average number of full calls or e-mails was 6.41 per participant.

CHESS+Mentor intervention. For the CHESS+Mentor condition, the interactions and resources used were similar to those of the Mentor-only condition, but the interface also provided the mentor with a summary of the participant’s recent CHESS use and any concerns reported to CHESS, which helped the mentor assess knowledge and make tailored recommendations. The mentor could also refer participants to specific resources within CHESS, aided by knowledge of what parts of CHESS had or had not been used.

Assessment methods

Patients were given surveys at the baseline visit to complete and mail back to research staff before randomization. Follow-up surveys were mailed to patients at 2, 6, 12, and 24 weeks post intervention access, and patients returned the surveys by mail. Patient withdrawal rates were about 3%.

Measures

Outcomes. This study included 4 measures of quality of life (an average of relevant portions of the World Health Organization’s Quality of Life (WHOQOL) measure, Emotional and Functional Well-being, and a prostate-cancer specific index, the Expanded Prostate Cancer Index Composite (EPIC). We also tested group differences on 5 more specific outcomes that were likely to be proximal rather than distal effects of the interventions: Cancer Information Competence, Health care Competence, Social Support, Bonding (with other patients), and Positive Coping.



Quality of life. Quality of life was measured by combining the psychological, social, and overall dimensions of the WHOQOL measures.²³ Each of the 11 items was assessed with a 5-point scale, and the mean of those answers was the overall score.



Emotional well-being. Respondents answered 6 items of the Functional Assessment of Cancer Therapy – Prostate (FACT-P)²⁴ describing emotional aspects of reactions to cancer.



Functional well-being. Respondents indicated how often they experienced each of the seven functional well-being subscale items of the FACT-Prostate.²⁴



Prostate cancer patient functioning. We used the EPIC to measure of 3 of 4 domains of prostate cancer patient functioning: urinary, bowel, and sexual (omitting hormonal).²⁵ The EPIC measures frequency and subjective degree of being a problem of several aspects in each domain. We then summed scores across the domains and transformed linearly to a 0-100 scale, with higher scores representing better functioning.



Cancer information competence. Five cancer information competence items, measured on a 5-point scale, assessed a participant’s perception about whether he could find and effectively and use health information, and were summed to create a single score.²⁰



Social support. Six 5-point social support items assessed the informational and emotional support provided by friends, family, coworkers, and others, and were summed to create a single score.²⁰



Health care competence. Five 5-point health care competence items assessed a patient’s comfort and activation level dealing with physicians and health care situations, and were summed to create a single score.²⁰



Positive coping. Coping strategies were measured with the Brief Cope, a shorter version of the original 60-item COPE scale.²⁶ Positive coping strategy, a predictor of positive adaptation in numerous coping contexts, was measured with the mean score of 4 scales (8 items in all): active coping, planning, positive reframing, and humor.



Bonding. Bonding with other prostate cancer patients was measured with five 5-point items about how frequently participants connected with and got information and support from other men with prostate cancer.²⁷



User vs nonuser. Intent-to-treat analyses compared the assigned conditions. However, because CHESS use was self-selected and available at any time whereas mentor calls were scheduled and initiated by another person, the proportion actually using the interventions was quite different.

Since a participant assigned access to CHESS had to select the URL, even a single entry to the system was counted as use. Of 198 participants assigned to either the CHESS or CHESS+Mentor conditions, 43 (22%) never logged in and were classified as nonusers.

Because the mentor scheduled calls and attempted repeatedly to complete scheduled calls, the patient was in a reactive position, and the decision not to use the mentor’s services could come at the earliest at the end of a first completed call. However, after examining call notes and consulting with the mentors, it was clear that opting not to receive mentoring typically occurred at the second call. Furthermore, much (though not all) of the first call was typically taken up with getting acquainted and scheduling issues, so that defining “nonuse” as 2 or fewer completed calls was most faithful to what actually happened. Of 202 participants assigned access to a mentor, 16 (8%) were thus defined as nonusers.

Results

Overall, the participants were about 60 years of age and had some college education and middle-class incomes (Table 1). Only about 10% were minorities or lived alone, and their comfort using computers and the Internet was at or above the “quite comfortable” level. None of groups differed significantly from any other.

The 2 primary hypotheses of the study were that participants in the combined condition would manifest higher outcome scores than those with either intervention alone. Table 2 displays group means at 3 posttest intervals, controlling for theoretically chosen covariates (age, education, and minority status) and pretest levels of the dependent variable. The table also summarizes tests examining the hypotheses and the comparison of CHESS and Mentor conditions. The 4 quality-of-life scores appear first, followed by 5 more specific outcomes that are perhaps more proximal effects of these interventions.

Discussion

We used a randomized control design to test whether combining computer-based and human interventions would provide greater benefits to prostate cancer patients than either alone, as previous research had shown for breast cancer patients.¹⁸ The computer-based resource was CHESS, a repeatedly evaluated integrated system combining information, social support, and interactive tools to help patients manage their response to disease. The human cancer information mentor intervention combined the expertise of NCI’s Cancer Information Service with the repeated contact more typical of peer mentoring. Previous research with breast cancer patients had shown both interventions to provide greater information, support, and quality-of-life benefits than Internet access alone.¹⁴ This study also compared outcomes obtained by the separate CHESS and Mentor conditions, but without predicting a direction of difference.

Tests at 6 weeks, 3 months and 6 months after intervention found instances in which prostate cancer patients assigned to the combined CHESS+Mentor condition experienced more positive quality of life or other outcomes than those assigned to CHESS or Mentor alone, but those differences were scattered rather than consistent. In the direct comparisons of the separate CHESS and Mentor conditions, significance was even rarer, but outcome scores tended to be higher in the Mentor condition than in the CHESS condition.

We noted that differential uptake of the 2 interventions (92% for Mentor vs 78% for CHESS) made interpreting the intent-to-treat analyses problematic, as the mentor’s control of the call schedule meant that far more patients in that condition actually received at least some intervention than in the CHESS condition, where patients used or did not use CHESS entirely at their own volition. This could have biased results in several ways, such as by underestimating the efficacy of the CHESS condition alone and thus inflating the contrast between CHESS alone and CHESS+Mentor. Or the combined condition might have been less different than the Mentor-only condition than intended, thus making for a conservative test of that comparison. However, post hoc analyses of only those participants who had actually used their assigned interventions (and this led to some reclassification of those originally assigned to the CHESS+Mentor condition) produced results that were little different than the intent-to-treat analysis.

Thus, although the combined condition produced some small advantages over either intervention alone, these advantages did not live up to expectations or to previous experience with breast cancer patients.¹⁷ We expected the mentor to be able to reinforce and help interpret what the participants learned from CHESS and their clinicians, and also to advise and direct these patients to be much more effective users of CHESS and other resources. Similarly, we expected that CHESS would make patients much better prepared for mentoring, so that instead of dealing with routine information matters, the mentor could go into greater detail or deal with more complex issues. Their combined effect should have been much larger than each alone, and that was not the case. Perhaps from the prostate cancer patients’ perspective, the 2 interventions seemed to offer similar resources, and a patient benefitted from one or the other but expected no additional gain from attending to both.

The 2 interventions themselves seemed nearly equally effective. The Mentor intervention was significantly stronger than CHESS in only 1 of 27 tests in the intent-to-treat analysis and 2 in the analysis limited to intervention users.

These results for prostate cancer patients are somewhat weaker than those previously reported with breast cancer patients.¹⁷ It is possible that prostate cancer patients (or men in general) are less inclined to seek health information, support, and health self-management than breast cancer patients (or women in general), perhaps because many men perceive decision-making to end with initial treatment, whereas women typically deal with follow-up treatments as well. Use of CHESS and the mentor was modestly lower for the men here than for the women in the previous studies. It is also possible that the CHESS Prostate Cancer module was not as good as the Breast Cancer module, although we are doubtful of that, given the additional tools and improvements added here in response to quite good focus group participants.²²It may also be true that as time goes on, the relative advantage of these interventions over support generally available over the Internet is simply waning – other websites are getting richer and more sophisticated, and users are getting better at searching them out (and avoiding weak or commercially motivated sites).

Although these interventions were experienced by prostate cancer patients in their homes in natural and familiar ways, any experimental manipulation must acknowledge possible problems with external validity. More important here, our recruitment procedures may have produced self-selection to enter or not enter the study in 2 ways that limit its applicability. First, although we thought that offering Internet access to all participants would make participation more likely, the most frequent reason men gave in declining to join the study was “not a computer person.” Our participants were certainly very comfortable with computers and the Internet, and most used them frequently even before the study. Second, it seems that, except for their prostate cancer, our sample was healthy in other respects, as indicated by the low number of other health care visits or surgeries/hospitalization they reported (and “overwhelmed” and “too busy,” 2 common reasons for declining study participations could also be coming from men with more comorbidities). Thus, our sample was probably more computer literate and healthier than the general population of prostate cancer patients.

Nonetheless, for policymakers deciding what information and support interventions to put in place for prostate cancer patients (or more generally for other cancer patients as well), these results have 2 implications. First, since the combination of the mentor and CHESS produced only small advantages over either alone, the extra effort of doing both seems clearly unwarranted for prostate cancer patients. The somewhat larger advantage of the combined intervention shown for breast cancer patients in previous studiesmight warrant using the combination in some circumstances, but even that is not clear-cut.

Finding that CHESS and the cancer information mentor separately provided essentially equal benefits might seem to suggest that they can be regarded as alternatives. However, computer-based services can be provided much more cheaply and scaled up far more readily than services dependent on one-on-one contacts by a highly trained professional. This may direct health care decision makers first toward computer-based services.

Prostate cancer is the most common cancer among men and the second leading cause of cancer-related death in men. ¹ Treatment choices for prostate cancer are perhaps more varied than for many other cancers, with surgery, external beam radiation therapy, and brachytherapy all widely used, a number of adjuvant and nonstandard therapy options available, as well as the possibility of not immediately treating the cancer – the “active surveillance” option.

Biochemical failure rates do not differ between the 3 main treatments,² but each exposes patients to the risk of side effects, including impotence, incontinence, rectal injury, and operative mortality. Recovery can be gradual and will not always involve a return to baseline functioning.³ Quality-of-life comparisons observed covariate-controlled decreases in varying specific aspects of quality of life for each of the treatments.⁴

Surgery, brachytherapy, and external beam radiation therapy have each shown advantages over other treatments on at least some specific aspect, but disadvantages on others.⁴ Ongoing surveillance of a cancer left in place has become a more common option in part because of the disadvantages of traditional treatment and because of the growing recognition that sensitive diagnosis techniques often locate cancers that might not be life threatening. Recent reviews and reasonably long-term trials portray active surveillance as a valid alternative to surgery and radiation in many cases, with little difference in life expectancy and cancer-related quality of life, and possibly some reduction in health system cost.^5-7

Prostate cancer patients cope with these uncertainties and decisions in many ways,⁸ often using multiple coping behaviors,⁹ but coping almost always includes seeking information and social support, as well as active problem-solving, to make informed treatment decisions consistent with their values.

Unfortunately, prostate patients often do not receive or use needed information. McGregor¹⁰ reported that patients were aware of their incomplete understanding of their disease and treatment options. Findings from several studies suggest that patients often perceive that clinicians inform them about the disease and treatment options but then send them home unprepared to deal with such things as incontinence or difficulties with sexual functioning.¹¹

Similarly, previous research demonstrates the benefits of social support for prostate cancer patients who receive it, but also that overall they are underserved.^12,13 Male cancer patients are generally far less likely to seek support and health information than are female patients. And when patients with prostate cancer do participate in online cancer support groups, they are more likely to exchange information, whereas breast cancer patients provide support for each other.¹⁴

Mentoring

Some responses to these knowledge and support gaps pair newly diagnosed patients with survivors willing to be a guide, coach, and a source of information, as in the American Cancer Society’s (ACS’s) Man-to-Man support groups.¹⁵ Peer mentors may have a sophisticated level of understanding from their own experiences with medical literature and the health care system, but this cannot be assumed. Another mentoring model is expert-based, exemplified by the National Cancer Institute’s (NCI’s) cancer information specialist at the Cancer Information Service (CIS) and a similar system at the ACS. These telephone services allow for responsiveness to the caller’s needs, existing knowledge, and the caller’s readiness for information. The CIS specialist can also introduce important information the caller might not have known to ask about.¹⁶

However, not all problems presented by callers can be solved in a single conversation. Callers are encouraged to call back with additional questions or when their situation changes, but speaking with the same specialist is not facilitated, so it is hard for a second call to build upon the first. Combining the expertise of the cancer information specialist with the ongoing and proactive contact and support typical of the lay guide/mentor/navigator could be more effective. Here a CIS-trained information specialist called prostate patients multiple times over the intervention period to help them deal with information seeking and interpretation. In a previous study with breast cancer patients, a mentor of this sort improved patient information competence and emotional processing.¹⁷

Interactive resources

Online resources allow cancer patients self-paced and self-directed access to information and support anonymously and at any time. However, this can be more complicated than it might at first seem. With the complexities of the prostate cancer diagnosis, the multiple treatment options, and the uncertain but potentially serious effects of the treatments themselves, the amount of potentially relevant information is quite large. Then, because individuals will value differentially the attributes of treatments, their consequences, or even notions of risk and gain, a system must be able to respond appropriately to a range of very different people. Beyond this, as prostate cancer patients move from the shock of a cancer diagnosis to the problems of interpreting its details, to making treatment decisions, to dealing with problems of recovery, and then re-establishing what is a “new normal” for them, an individual’s demands on a system vary as well. Comprehensive and integrated systems of services meet the varying needs of their users at different times and different situations.^18,19 The systems approach not only makes it far easier for users to find what they need, it may also encourage them to see connections between physical, emotional, and social aspects of their illness. Versions of the system used in the present study – CHESS, or Comprehensive Health Enhancement Support System – have been effective supporting patients with AIDS and breast and lung cancers, and teens with asthma.^16,20

Study goals and hypotheses

Given the success of the 2 aforementioned approaches, we wanted to compare how CHESS and ongoing contact with a human cancer information mentor in patients with prostate cancer would affect both several general aspects of quality of life and 1 specific to prostate cancer. We also examined differences in the patients’ information competence, quality of life, and social support. There was no a priori expectation that one intervention would be superior to the other, but any differences found could be important to policy decisions, given their quite-different cost and scalability.

More importantly, the primary hypothesis of the study was that patients with access to both CHESS and a mentor would experience substantially better outcomes than those with access to either intervention alone, because each had the potential to enhance the other’s benefits. For example, a patient could read CHESS material and come to the mentor much better prepared. By referring the user to specific parts of CHESS for basic information, the mentor could use calls to address more complex issues, or help interpret and evaluate difficult issues. In addition, because CHESS provides the mentor information about changes in the patient’s treatments, symptoms, and CHESS use, in the combined condition the cancer information mentor can know much more about the patient than when working alone. We also expected that the mentor would stimulate the kind of diverse use of CHESS services we have found to be most effective for improving quality of life.²¹ A previous study of CHESS for women with breast cancer concluded that a combined condition benefitted patients more than either CHESS or a cancer mentor alone,¹⁷ and we sought to determine whether we would have similar results with men with prostate cancer.

Because both mentoring and CHESS have consistently produced positive quality of life effects on their own, compared to controls, there is no reasonable expectation that negative effects of a combined condition could occur and should be tested for. Thus, the study was powered for 1-tailed significance in the comparison between the combined condition and either intervention alone, a procedure used consistently in previous studies of CHESS components or combined conditions. However, since the research question comparing the 2 interventions alone had no such strong history it was tested 2-tailed.
 

Methods

Recruitment

Study recruitment was conducted from January 1, 2007 to September 30, 2008 at the University of Wisconsin’s Paul P Carbone Comprehensive Cancer Center in Madison, Hartford Hospital’s Helen and Harry Gray Cancer Center in Hartford, Connecticut, and The University of Texas MD Anderson Cancer Center in Houston.

A total of 461 patients were invited to participate in the study. Of those patients, 147 declined to participate, 4 were excluded, and 310 were randomized to access to CHESS only, access to a human mentor only, or access to CHESS and a mentor (CHESS+Mentor) during the 6-month intervention period, which provided adequate power (>.80) for effects of moderate size (Figure 1). Randomization was done with a computer-generated list that site study managers accessed on a patient-by-patient basis, with experimental conditions blocked within sites.

Interventions

To provide an equal baseline, all of the participants were given access to the Internet, which is becoming a de facto standard for information access. Internet access charges were paid for all participants during the 6-month intervention period, and computers were loaned to those who did not have a personal computer. All of the participants were offered training on using the computer, particularly with Google search procedures so that they could access resources on prostate cancer.

Participants assigned to the CHESS or CHESS+Mentor conditions were also offered training in using CHESS (basically a guided tour), which typically took about 30 minutes on the telephone but was occasionally done in-person.

CHESS intervention. In creating CHESS for prostate cancer patients, a combination of patient needs assessments, focus groups with patients and family members, and clinician expertise helped us identify the needs, coping mechanisms, and relevant medical information to help patients respond to the disease. An article describing development of the CHESS Prostate Cancer Module²² presents how those different services address patient needs for information, communication, and support, or build skills.

Most of these services were present in CHESS for other diseases, but several were newly created to meet needs of prostate cancer patients and partners, such as a decision map tool and a module on managing sexual problems.²² Also, patients expressed frustration at being overwhelmed by the volume of information and said they would prefer to focus only on what was most relevant, so we created an alternative navigation structure on the CHESS homepage. Using terms suggested by focus groups of prostate cancer survivors and their spouses, we devised a navigation structure called Step-by-Step that identified 6 typical sequential steps of men’s experience with prostate cancer. Clicking on a step would take a patient to a menu focused on actions and considerations specific to that disease step, links to information most relevant at that step, and suggested questions to ask oneself and one’s doctor.

Mentor intervention. The cancer information mentor who made most of the calls to patients was an experienced information specialist with the Cancer Information Service and had served as the expert for the CHESS Ask an Expert service for 6 years. She was highly knowledgeable about prostate cancer and patient information needs. Her additional training for this study focused on taking advantage of repeated contacts with the participants and how to set limits to avoid any semblance of psychological counseling. At recruitment, we made clear that a male mentor was also available if the participant would prefer to discuss sensitive topics with another man. The male mentor was experienced in the Man-to-Man program and received additional training for this role, but he was used for only 1% of all contacts.

During calls, the mentor had Internet access to a range of NCI, ACS, and other resources. She could help interpret information the participant already possessed as well as refer him to other public resources, including those on the Internet. CHESS software designers created an additional interface for the mentor that handled call scheduling and allowed her to record the topics of conversations, her responses and recommendations, and her overall ratings of patient preparedness and satisfaction. Using this interface allowed the mentor to quickly review a participant’s status and focus the conversation on issues raised by past conversations or scheduled treatment events. The mentor calls were audiorecorded and reviewed frequently by the project director during the early months of intervention and less frequently thereafter to ensure adherence to the protocol.

The mentor telephoned weekly during the first month of intervention, then twice during the second month, and once a month during the final 4 months of the intervention (ie, 10 scheduled calls, though patients could also initiate additional calls). Calls were scheduled through a combination of telephone contact and e-mail according to the patient’s preference. Call length ranged from 5 minutes to an hour, with the average about 12 minutes (the first call tended to be considerably longer, and was scheduled for 45 minutes). About 10%-15% of participants in the Mentor conditions initiated calls to the mentor to obtain additional support, and about 15% of scheduled calls in fact took place as e-mail exchanges. A few calls were missed because of scheduling difficulties, and some participants stopped scheduling the last few calls, but the average number of full calls or e-mails was 6.41 per participant.

CHESS+Mentor intervention. For the CHESS+Mentor condition, the interactions and resources used were similar to those of the Mentor-only condition, but the interface also provided the mentor with a summary of the participant’s recent CHESS use and any concerns reported to CHESS, which helped the mentor assess knowledge and make tailored recommendations. The mentor could also refer participants to specific resources within CHESS, aided by knowledge of what parts of CHESS had or had not been used.

Assessment methods

Patients were given surveys at the baseline visit to complete and mail back to research staff before randomization. Follow-up surveys were mailed to patients at 2, 6, 12, and 24 weeks post intervention access, and patients returned the surveys by mail. Patient withdrawal rates were about 3%.

Measures

Outcomes. This study included 4 measures of quality of life (an average of relevant portions of the World Health Organization’s Quality of Life (WHOQOL) measure, Emotional and Functional Well-being, and a prostate-cancer specific index, the Expanded Prostate Cancer Index Composite (EPIC). We also tested group differences on 5 more specific outcomes that were likely to be proximal rather than distal effects of the interventions: Cancer Information Competence, Health care Competence, Social Support, Bonding (with other patients), and Positive Coping.



Quality of life. Quality of life was measured by combining the psychological, social, and overall dimensions of the WHOQOL measures.²³ Each of the 11 items was assessed with a 5-point scale, and the mean of those answers was the overall score.



Emotional well-being. Respondents answered 6 items of the Functional Assessment of Cancer Therapy – Prostate (FACT-P)²⁴ describing emotional aspects of reactions to cancer.



Functional well-being. Respondents indicated how often they experienced each of the seven functional well-being subscale items of the FACT-Prostate.²⁴



Prostate cancer patient functioning. We used the EPIC to measure of 3 of 4 domains of prostate cancer patient functioning: urinary, bowel, and sexual (omitting hormonal).²⁵ The EPIC measures frequency and subjective degree of being a problem of several aspects in each domain. We then summed scores across the domains and transformed linearly to a 0-100 scale, with higher scores representing better functioning.



Cancer information competence. Five cancer information competence items, measured on a 5-point scale, assessed a participant’s perception about whether he could find and effectively and use health information, and were summed to create a single score.²⁰



Social support. Six 5-point social support items assessed the informational and emotional support provided by friends, family, coworkers, and others, and were summed to create a single score.²⁰



Health care competence. Five 5-point health care competence items assessed a patient’s comfort and activation level dealing with physicians and health care situations, and were summed to create a single score.²⁰



Positive coping. Coping strategies were measured with the Brief Cope, a shorter version of the original 60-item COPE scale.²⁶ Positive coping strategy, a predictor of positive adaptation in numerous coping contexts, was measured with the mean score of 4 scales (8 items in all): active coping, planning, positive reframing, and humor.



Bonding. Bonding with other prostate cancer patients was measured with five 5-point items about how frequently participants connected with and got information and support from other men with prostate cancer.²⁷



User vs nonuser. Intent-to-treat analyses compared the assigned conditions. However, because CHESS use was self-selected and available at any time whereas mentor calls were scheduled and initiated by another person, the proportion actually using the interventions was quite different.

Since a participant assigned access to CHESS had to select the URL, even a single entry to the system was counted as use. Of 198 participants assigned to either the CHESS or CHESS+Mentor conditions, 43 (22%) never logged in and were classified as nonusers.

Because the mentor scheduled calls and attempted repeatedly to complete scheduled calls, the patient was in a reactive position, and the decision not to use the mentor’s services could come at the earliest at the end of a first completed call. However, after examining call notes and consulting with the mentors, it was clear that opting not to receive mentoring typically occurred at the second call. Furthermore, much (though not all) of the first call was typically taken up with getting acquainted and scheduling issues, so that defining “nonuse” as 2 or fewer completed calls was most faithful to what actually happened. Of 202 participants assigned access to a mentor, 16 (8%) were thus defined as nonusers.

Results

Overall, the participants were about 60 years of age and had some college education and middle-class incomes (Table 1). Only about 10% were minorities or lived alone, and their comfort using computers and the Internet was at or above the “quite comfortable” level. None of groups differed significantly from any other.

The 2 primary hypotheses of the study were that participants in the combined condition would manifest higher outcome scores than those with either intervention alone. Table 2 displays group means at 3 posttest intervals, controlling for theoretically chosen covariates (age, education, and minority status) and pretest levels of the dependent variable. The table also summarizes tests examining the hypotheses and the comparison of CHESS and Mentor conditions. The 4 quality-of-life scores appear first, followed by 5 more specific outcomes that are perhaps more proximal effects of these interventions.

Discussion

We used a randomized control design to test whether combining computer-based and human interventions would provide greater benefits to prostate cancer patients than either alone, as previous research had shown for breast cancer patients.¹⁸ The computer-based resource was CHESS, a repeatedly evaluated integrated system combining information, social support, and interactive tools to help patients manage their response to disease. The human cancer information mentor intervention combined the expertise of NCI’s Cancer Information Service with the repeated contact more typical of peer mentoring. Previous research with breast cancer patients had shown both interventions to provide greater information, support, and quality-of-life benefits than Internet access alone.¹⁴ This study also compared outcomes obtained by the separate CHESS and Mentor conditions, but without predicting a direction of difference.

Tests at 6 weeks, 3 months and 6 months after intervention found instances in which prostate cancer patients assigned to the combined CHESS+Mentor condition experienced more positive quality of life or other outcomes than those assigned to CHESS or Mentor alone, but those differences were scattered rather than consistent. In the direct comparisons of the separate CHESS and Mentor conditions, significance was even rarer, but outcome scores tended to be higher in the Mentor condition than in the CHESS condition.

We noted that differential uptake of the 2 interventions (92% for Mentor vs 78% for CHESS) made interpreting the intent-to-treat analyses problematic, as the mentor’s control of the call schedule meant that far more patients in that condition actually received at least some intervention than in the CHESS condition, where patients used or did not use CHESS entirely at their own volition. This could have biased results in several ways, such as by underestimating the efficacy of the CHESS condition alone and thus inflating the contrast between CHESS alone and CHESS+Mentor. Or the combined condition might have been less different than the Mentor-only condition than intended, thus making for a conservative test of that comparison. However, post hoc analyses of only those participants who had actually used their assigned interventions (and this led to some reclassification of those originally assigned to the CHESS+Mentor condition) produced results that were little different than the intent-to-treat analysis.

Thus, although the combined condition produced some small advantages over either intervention alone, these advantages did not live up to expectations or to previous experience with breast cancer patients.¹⁷ We expected the mentor to be able to reinforce and help interpret what the participants learned from CHESS and their clinicians, and also to advise and direct these patients to be much more effective users of CHESS and other resources. Similarly, we expected that CHESS would make patients much better prepared for mentoring, so that instead of dealing with routine information matters, the mentor could go into greater detail or deal with more complex issues. Their combined effect should have been much larger than each alone, and that was not the case. Perhaps from the prostate cancer patients’ perspective, the 2 interventions seemed to offer similar resources, and a patient benefitted from one or the other but expected no additional gain from attending to both.

The 2 interventions themselves seemed nearly equally effective. The Mentor intervention was significantly stronger than CHESS in only 1 of 27 tests in the intent-to-treat analysis and 2 in the analysis limited to intervention users.

These results for prostate cancer patients are somewhat weaker than those previously reported with breast cancer patients.¹⁷ It is possible that prostate cancer patients (or men in general) are less inclined to seek health information, support, and health self-management than breast cancer patients (or women in general), perhaps because many men perceive decision-making to end with initial treatment, whereas women typically deal with follow-up treatments as well. Use of CHESS and the mentor was modestly lower for the men here than for the women in the previous studies. It is also possible that the CHESS Prostate Cancer module was not as good as the Breast Cancer module, although we are doubtful of that, given the additional tools and improvements added here in response to quite good focus group participants.²²It may also be true that as time goes on, the relative advantage of these interventions over support generally available over the Internet is simply waning – other websites are getting richer and more sophisticated, and users are getting better at searching them out (and avoiding weak or commercially motivated sites).

Although these interventions were experienced by prostate cancer patients in their homes in natural and familiar ways, any experimental manipulation must acknowledge possible problems with external validity. More important here, our recruitment procedures may have produced self-selection to enter or not enter the study in 2 ways that limit its applicability. First, although we thought that offering Internet access to all participants would make participation more likely, the most frequent reason men gave in declining to join the study was “not a computer person.” Our participants were certainly very comfortable with computers and the Internet, and most used them frequently even before the study. Second, it seems that, except for their prostate cancer, our sample was healthy in other respects, as indicated by the low number of other health care visits or surgeries/hospitalization they reported (and “overwhelmed” and “too busy,” 2 common reasons for declining study participations could also be coming from men with more comorbidities). Thus, our sample was probably more computer literate and healthier than the general population of prostate cancer patients.

Nonetheless, for policymakers deciding what information and support interventions to put in place for prostate cancer patients (or more generally for other cancer patients as well), these results have 2 implications. First, since the combination of the mentor and CHESS produced only small advantages over either alone, the extra effort of doing both seems clearly unwarranted for prostate cancer patients. The somewhat larger advantage of the combined intervention shown for breast cancer patients in previous studiesmight warrant using the combination in some circumstances, but even that is not clear-cut.

Finding that CHESS and the cancer information mentor separately provided essentially equal benefits might seem to suggest that they can be regarded as alternatives. However, computer-based services can be provided much more cheaply and scaled up far more readily than services dependent on one-on-one contacts by a highly trained professional. This may direct health care decision makers first toward computer-based services.