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Low EGFR Expression Predicts ARCON Benefit in Laryngeal Cancer
LONDON – Expression of the epidermal growth factor receptor predicts whether patients with laryngeal cancer will benefit from hypoxia modification in addition to accelerated radiotherapy.
Study findings reported May 9 at the European Society for Therapeutic Radiation Oncology (ESTRO) Anniversary Conference showed that low expression was associated with higher disease-specific survival and locoregional control than was high expression in patients who received ARCON (accelerated radiotherapy with carbogen and nicotinamide).
EGFR expression is prognostic for patients who are treated with conventional fractionated radiotherapy, but did not predict response in patients undergoing just AR (accelerated radiotherapy) without hypoxia modification.
"EGFR can activate different downstream signaling pathways [in the tumor cell] that – once activated – can influence tumor cell survival, proliferation, [and] migration," all of which can contribute to tumor progression, said Monique Nijkamp, a Ph.D. student in the radiation oncology department of St. Radboud University Medical Centre in Nijmegen, the Netherlands.
High expression has already been linked to worse outcome in patients who were treated with radiotherapy for head and neck cancer (Cancer Res. 2002;62:7350-6). Ms. Nijkamp said that EGFR could be activated by ionizing radiation, and could account for resistance to radiotherapy in some treated individuals.
Hypothesizing that ARCON may help to overcome this resistance, Ms. Nikamp and coworkers examined 272 biopsy samples taken from 345 patients who had been treated with accelerated radiotherapy, with or without hypoxia modification, in a phase III study.
Preliminary results of the study were reported last September at the ESTRO 29 meeting in Barcelona. They showed that ARCON significantly improved regional – but not locoregional – tumor control, compared with AR alone. All of the patients in the trial had advanced-stage laryngeal cancer.
The latest findings suggest that patients with high expression may not gain any extra benefit from the addition of hypoxia modification. Indeed, although not statistically significant, better 5-year locoregional control (88% vs. 71%) and disease-specific survival (91% vs. 78%) were seen in patients with low EGFR expression than in those with high EGFR expression who were treated with ARCON.
Ms. Nijkamp suggested that perhaps high EGFR–expressing tumors were rapidly activating downstream signaling pathways that negated the effects of hypoxia modification. No difference in outcomes was found according to EGFR expression in the AR alone arm.
"There is concern over the methodologies used to measure EGFR, and this could have a large bearing on what conclusions can be drawn from studies," said Dr. Nick Slevin, who was invited to comment on the findings.
"From the literature and from this study, it appears that high EGFR laryngeal cancers benefit from accelerated radiotherapy, but that low EGFR tumors do not," added Dr. Slevin, a consultant clinical oncologist at the Christie NHS Foundation Trust and the University of Manchester (England).
"I think it’s a fair summary to also say that high-EGFR tumors benefit from AR but not from CON [carbogen and nicotinamide] and that low-EGFR tumors benefit from the CON but not the AR. ... So I’m not sure ARCON is the right approach for all tumors."
Other approaches to hypoxia modification for low EGFR–expressing tumors (such as oral nimorazole) may overcome the logistic difficulties of delivering carbogen and nicotinamide, he added.
The study was supported by the Dutch Cancer Society. Ms. Nijkamp and Dr. Slevin declared they had no financial conflicts of interest.
LONDON – Expression of the epidermal growth factor receptor predicts whether patients with laryngeal cancer will benefit from hypoxia modification in addition to accelerated radiotherapy.
Study findings reported May 9 at the European Society for Therapeutic Radiation Oncology (ESTRO) Anniversary Conference showed that low expression was associated with higher disease-specific survival and locoregional control than was high expression in patients who received ARCON (accelerated radiotherapy with carbogen and nicotinamide).
EGFR expression is prognostic for patients who are treated with conventional fractionated radiotherapy, but did not predict response in patients undergoing just AR (accelerated radiotherapy) without hypoxia modification.
"EGFR can activate different downstream signaling pathways [in the tumor cell] that – once activated – can influence tumor cell survival, proliferation, [and] migration," all of which can contribute to tumor progression, said Monique Nijkamp, a Ph.D. student in the radiation oncology department of St. Radboud University Medical Centre in Nijmegen, the Netherlands.
High expression has already been linked to worse outcome in patients who were treated with radiotherapy for head and neck cancer (Cancer Res. 2002;62:7350-6). Ms. Nijkamp said that EGFR could be activated by ionizing radiation, and could account for resistance to radiotherapy in some treated individuals.
Hypothesizing that ARCON may help to overcome this resistance, Ms. Nikamp and coworkers examined 272 biopsy samples taken from 345 patients who had been treated with accelerated radiotherapy, with or without hypoxia modification, in a phase III study.
Preliminary results of the study were reported last September at the ESTRO 29 meeting in Barcelona. They showed that ARCON significantly improved regional – but not locoregional – tumor control, compared with AR alone. All of the patients in the trial had advanced-stage laryngeal cancer.
The latest findings suggest that patients with high expression may not gain any extra benefit from the addition of hypoxia modification. Indeed, although not statistically significant, better 5-year locoregional control (88% vs. 71%) and disease-specific survival (91% vs. 78%) were seen in patients with low EGFR expression than in those with high EGFR expression who were treated with ARCON.
Ms. Nijkamp suggested that perhaps high EGFR–expressing tumors were rapidly activating downstream signaling pathways that negated the effects of hypoxia modification. No difference in outcomes was found according to EGFR expression in the AR alone arm.
"There is concern over the methodologies used to measure EGFR, and this could have a large bearing on what conclusions can be drawn from studies," said Dr. Nick Slevin, who was invited to comment on the findings.
"From the literature and from this study, it appears that high EGFR laryngeal cancers benefit from accelerated radiotherapy, but that low EGFR tumors do not," added Dr. Slevin, a consultant clinical oncologist at the Christie NHS Foundation Trust and the University of Manchester (England).
"I think it’s a fair summary to also say that high-EGFR tumors benefit from AR but not from CON [carbogen and nicotinamide] and that low-EGFR tumors benefit from the CON but not the AR. ... So I’m not sure ARCON is the right approach for all tumors."
Other approaches to hypoxia modification for low EGFR–expressing tumors (such as oral nimorazole) may overcome the logistic difficulties of delivering carbogen and nicotinamide, he added.
The study was supported by the Dutch Cancer Society. Ms. Nijkamp and Dr. Slevin declared they had no financial conflicts of interest.
LONDON – Expression of the epidermal growth factor receptor predicts whether patients with laryngeal cancer will benefit from hypoxia modification in addition to accelerated radiotherapy.
Study findings reported May 9 at the European Society for Therapeutic Radiation Oncology (ESTRO) Anniversary Conference showed that low expression was associated with higher disease-specific survival and locoregional control than was high expression in patients who received ARCON (accelerated radiotherapy with carbogen and nicotinamide).
EGFR expression is prognostic for patients who are treated with conventional fractionated radiotherapy, but did not predict response in patients undergoing just AR (accelerated radiotherapy) without hypoxia modification.
"EGFR can activate different downstream signaling pathways [in the tumor cell] that – once activated – can influence tumor cell survival, proliferation, [and] migration," all of which can contribute to tumor progression, said Monique Nijkamp, a Ph.D. student in the radiation oncology department of St. Radboud University Medical Centre in Nijmegen, the Netherlands.
High expression has already been linked to worse outcome in patients who were treated with radiotherapy for head and neck cancer (Cancer Res. 2002;62:7350-6). Ms. Nijkamp said that EGFR could be activated by ionizing radiation, and could account for resistance to radiotherapy in some treated individuals.
Hypothesizing that ARCON may help to overcome this resistance, Ms. Nikamp and coworkers examined 272 biopsy samples taken from 345 patients who had been treated with accelerated radiotherapy, with or without hypoxia modification, in a phase III study.
Preliminary results of the study were reported last September at the ESTRO 29 meeting in Barcelona. They showed that ARCON significantly improved regional – but not locoregional – tumor control, compared with AR alone. All of the patients in the trial had advanced-stage laryngeal cancer.
The latest findings suggest that patients with high expression may not gain any extra benefit from the addition of hypoxia modification. Indeed, although not statistically significant, better 5-year locoregional control (88% vs. 71%) and disease-specific survival (91% vs. 78%) were seen in patients with low EGFR expression than in those with high EGFR expression who were treated with ARCON.
Ms. Nijkamp suggested that perhaps high EGFR–expressing tumors were rapidly activating downstream signaling pathways that negated the effects of hypoxia modification. No difference in outcomes was found according to EGFR expression in the AR alone arm.
"There is concern over the methodologies used to measure EGFR, and this could have a large bearing on what conclusions can be drawn from studies," said Dr. Nick Slevin, who was invited to comment on the findings.
"From the literature and from this study, it appears that high EGFR laryngeal cancers benefit from accelerated radiotherapy, but that low EGFR tumors do not," added Dr. Slevin, a consultant clinical oncologist at the Christie NHS Foundation Trust and the University of Manchester (England).
"I think it’s a fair summary to also say that high-EGFR tumors benefit from AR but not from CON [carbogen and nicotinamide] and that low-EGFR tumors benefit from the CON but not the AR. ... So I’m not sure ARCON is the right approach for all tumors."
Other approaches to hypoxia modification for low EGFR–expressing tumors (such as oral nimorazole) may overcome the logistic difficulties of delivering carbogen and nicotinamide, he added.
The study was supported by the Dutch Cancer Society. Ms. Nijkamp and Dr. Slevin declared they had no financial conflicts of interest.
FROM THE EUROPEAN SOCIETY FOR THERAPEUTIC RADIATION ONCOLOGY ANNIVERSARY CONFERENCE
Major Finding: The rates of 5-year locoregional control (88% vs. 71%) and disease-specific survival (91% vs. 78%) were better with low vs. high EGFR expression in patients who were treated with ARCON.
Data Source: Immunohistochemical analysis of 272 biopsy samples from 345 patients who were treated with accelerated radiotherapy, with or without hypoxia modification, in a phase III study.
Disclosures: The study was supported by the Dutch Cancer Society. Ms. Nijkamp and Dr. Slevin declared that they had no financial conflicts of interest.
Two Factors Predict Postradiotherapy Swallowing Difficulties
LONDON – Nonglottic cancer and the presence of dysphagia before treatment are highly predictive for severe acute and late swallowing difficulties after radiotherapy for head and neck cancer, according to new data from the DAHANCA 6&7 randomized trial.
Patients with nonglottic cancer were more likely than those with other cancer types to experience severe dysphagia at both 6 and 12 months. Dysphagia before treatment was also associated with both acute and late severe swallowing difficulties.
"The peak incidence of dysphagia is seen during the first 6 months after radiotherapy," Hanna Rahbek Mortensen, Ph.D., reported in an analysis of the DAHANCA (Danish Head and Neck Cancer Group) 6&7 trial findings at the European Society for Therapeutic Radiation Oncology Anniversary Congress.
"After 1 year, however, there is no further increase in severity or prevalence," said Dr. Mortensen of the department of experimental clinical oncology at Åarhus (Denmark) University Hospital.
The trial involved 1,478 patients with squamous cell carcinomas of the glottic larynx, supraglottic larynx, pharynx, or oral cavity who were who were treated with five or six weekly fractions of radiotherapy in 1992-1999. The total dose of radiotherapy delivered was 66-68 Gy in 33-34 fractions.
Efficacy data from the trial have already been published; they showed improved disease-specific but not overall survival of five vs. six fractions of radiotherapy (Lancet 2003;362:933-40).
The aim of the present analysis was to use prospectively collected data from the trial to determine whether any factors could be used to establish which patients may be more likely than others to experience dysphagia following treatment.
"Dysphagia is a common and debilitating side effect of radiotherapy, leading to malnutrition, aspiration, and reduced quality of life," Dr. Mortensen explained. The side effect can be graded using a 5-point scale, with a score of 0 signifying no dysphagia and a score of 3 or 4 indicating considerable or severe dysphagia despite the ingestion of a liquid-only diet.
In all, 1,422 (96%) patients experienced acute dysphagia, including severe grade 3/4 dysphagia in 47% and 38% of those receiving accelerated or conventional radiotherapy, respectively. The two factors most predictive for severe dysphagia at 6 months were nonglottic cancer (odds ratio, 6.73 vs. other sites; P less than .0001) and a baseline dysphagia score of 2-4 vs. 0-1 (OR, 2.11; P =.004).
Odd ratios for other factors predictive for acute – but not late – dysphagia were 1.92 for any (N1-N3) vs. no (N0) nodal involvement (P less than .001), 1.82 for the use of accelerated (six weekly fractions) vs. conventional (five weekly fractions) radiotherapy (P less than .001), and 1.58 for stage T3-T4 vs. stage T1-T2 cancer (P = .02).
After 5-years of regular follow-up, late dysphagia had occurred in 1,205 patients (81%), with grade 3 severity in 24% and grade 4 in 23%. Factors that were predictive for late severe dysphagia that occurred 12 months after radiotherapy were, again, nonglottic cancer (OR, 8.25; P less than .0001) and a baseline dysphagia score greater than 1 (OR, 2.57; P less than .002). Late (T3-T4) tumor stage was also predictive (OR, 1.86; P = .03).
"Predictive factors have been identified to characterize patients at risk of developing acute and late dysphagia," Dr. Mortensen said. These factors may be useful to identify patients who could perhaps benefit from prophylactic measures against swallowing dysfunction.
The DAHANCA 6&7 trial was supported by the Danish Cancer Society, Åarhus University Hospital, Copenhagen University Hospital, Herlev (Denmark) Hospital, Odense (Denmark) University Hospital, and Aalborg (Denmark) Hospital on behalf of DAHANCA. Dr. Mortensen had no personal financial disclosures to declare.
LONDON – Nonglottic cancer and the presence of dysphagia before treatment are highly predictive for severe acute and late swallowing difficulties after radiotherapy for head and neck cancer, according to new data from the DAHANCA 6&7 randomized trial.
Patients with nonglottic cancer were more likely than those with other cancer types to experience severe dysphagia at both 6 and 12 months. Dysphagia before treatment was also associated with both acute and late severe swallowing difficulties.
"The peak incidence of dysphagia is seen during the first 6 months after radiotherapy," Hanna Rahbek Mortensen, Ph.D., reported in an analysis of the DAHANCA (Danish Head and Neck Cancer Group) 6&7 trial findings at the European Society for Therapeutic Radiation Oncology Anniversary Congress.
"After 1 year, however, there is no further increase in severity or prevalence," said Dr. Mortensen of the department of experimental clinical oncology at Åarhus (Denmark) University Hospital.
The trial involved 1,478 patients with squamous cell carcinomas of the glottic larynx, supraglottic larynx, pharynx, or oral cavity who were who were treated with five or six weekly fractions of radiotherapy in 1992-1999. The total dose of radiotherapy delivered was 66-68 Gy in 33-34 fractions.
Efficacy data from the trial have already been published; they showed improved disease-specific but not overall survival of five vs. six fractions of radiotherapy (Lancet 2003;362:933-40).
The aim of the present analysis was to use prospectively collected data from the trial to determine whether any factors could be used to establish which patients may be more likely than others to experience dysphagia following treatment.
"Dysphagia is a common and debilitating side effect of radiotherapy, leading to malnutrition, aspiration, and reduced quality of life," Dr. Mortensen explained. The side effect can be graded using a 5-point scale, with a score of 0 signifying no dysphagia and a score of 3 or 4 indicating considerable or severe dysphagia despite the ingestion of a liquid-only diet.
In all, 1,422 (96%) patients experienced acute dysphagia, including severe grade 3/4 dysphagia in 47% and 38% of those receiving accelerated or conventional radiotherapy, respectively. The two factors most predictive for severe dysphagia at 6 months were nonglottic cancer (odds ratio, 6.73 vs. other sites; P less than .0001) and a baseline dysphagia score of 2-4 vs. 0-1 (OR, 2.11; P =.004).
Odd ratios for other factors predictive for acute – but not late – dysphagia were 1.92 for any (N1-N3) vs. no (N0) nodal involvement (P less than .001), 1.82 for the use of accelerated (six weekly fractions) vs. conventional (five weekly fractions) radiotherapy (P less than .001), and 1.58 for stage T3-T4 vs. stage T1-T2 cancer (P = .02).
After 5-years of regular follow-up, late dysphagia had occurred in 1,205 patients (81%), with grade 3 severity in 24% and grade 4 in 23%. Factors that were predictive for late severe dysphagia that occurred 12 months after radiotherapy were, again, nonglottic cancer (OR, 8.25; P less than .0001) and a baseline dysphagia score greater than 1 (OR, 2.57; P less than .002). Late (T3-T4) tumor stage was also predictive (OR, 1.86; P = .03).
"Predictive factors have been identified to characterize patients at risk of developing acute and late dysphagia," Dr. Mortensen said. These factors may be useful to identify patients who could perhaps benefit from prophylactic measures against swallowing dysfunction.
The DAHANCA 6&7 trial was supported by the Danish Cancer Society, Åarhus University Hospital, Copenhagen University Hospital, Herlev (Denmark) Hospital, Odense (Denmark) University Hospital, and Aalborg (Denmark) Hospital on behalf of DAHANCA. Dr. Mortensen had no personal financial disclosures to declare.
LONDON – Nonglottic cancer and the presence of dysphagia before treatment are highly predictive for severe acute and late swallowing difficulties after radiotherapy for head and neck cancer, according to new data from the DAHANCA 6&7 randomized trial.
Patients with nonglottic cancer were more likely than those with other cancer types to experience severe dysphagia at both 6 and 12 months. Dysphagia before treatment was also associated with both acute and late severe swallowing difficulties.
"The peak incidence of dysphagia is seen during the first 6 months after radiotherapy," Hanna Rahbek Mortensen, Ph.D., reported in an analysis of the DAHANCA (Danish Head and Neck Cancer Group) 6&7 trial findings at the European Society for Therapeutic Radiation Oncology Anniversary Congress.
"After 1 year, however, there is no further increase in severity or prevalence," said Dr. Mortensen of the department of experimental clinical oncology at Åarhus (Denmark) University Hospital.
The trial involved 1,478 patients with squamous cell carcinomas of the glottic larynx, supraglottic larynx, pharynx, or oral cavity who were who were treated with five or six weekly fractions of radiotherapy in 1992-1999. The total dose of radiotherapy delivered was 66-68 Gy in 33-34 fractions.
Efficacy data from the trial have already been published; they showed improved disease-specific but not overall survival of five vs. six fractions of radiotherapy (Lancet 2003;362:933-40).
The aim of the present analysis was to use prospectively collected data from the trial to determine whether any factors could be used to establish which patients may be more likely than others to experience dysphagia following treatment.
"Dysphagia is a common and debilitating side effect of radiotherapy, leading to malnutrition, aspiration, and reduced quality of life," Dr. Mortensen explained. The side effect can be graded using a 5-point scale, with a score of 0 signifying no dysphagia and a score of 3 or 4 indicating considerable or severe dysphagia despite the ingestion of a liquid-only diet.
In all, 1,422 (96%) patients experienced acute dysphagia, including severe grade 3/4 dysphagia in 47% and 38% of those receiving accelerated or conventional radiotherapy, respectively. The two factors most predictive for severe dysphagia at 6 months were nonglottic cancer (odds ratio, 6.73 vs. other sites; P less than .0001) and a baseline dysphagia score of 2-4 vs. 0-1 (OR, 2.11; P =.004).
Odd ratios for other factors predictive for acute – but not late – dysphagia were 1.92 for any (N1-N3) vs. no (N0) nodal involvement (P less than .001), 1.82 for the use of accelerated (six weekly fractions) vs. conventional (five weekly fractions) radiotherapy (P less than .001), and 1.58 for stage T3-T4 vs. stage T1-T2 cancer (P = .02).
After 5-years of regular follow-up, late dysphagia had occurred in 1,205 patients (81%), with grade 3 severity in 24% and grade 4 in 23%. Factors that were predictive for late severe dysphagia that occurred 12 months after radiotherapy were, again, nonglottic cancer (OR, 8.25; P less than .0001) and a baseline dysphagia score greater than 1 (OR, 2.57; P less than .002). Late (T3-T4) tumor stage was also predictive (OR, 1.86; P = .03).
"Predictive factors have been identified to characterize patients at risk of developing acute and late dysphagia," Dr. Mortensen said. These factors may be useful to identify patients who could perhaps benefit from prophylactic measures against swallowing dysfunction.
The DAHANCA 6&7 trial was supported by the Danish Cancer Society, Åarhus University Hospital, Copenhagen University Hospital, Herlev (Denmark) Hospital, Odense (Denmark) University Hospital, and Aalborg (Denmark) Hospital on behalf of DAHANCA. Dr. Mortensen had no personal financial disclosures to declare.
FROM THE EUROPEAN SOCIETY FOR THERAPEUTIC RADIATION ONCOLOGY ANNIVERSARY CONFERENCE
Major Finding: The two factors most predictive for acute severe dysphagia at 6 months were nonglottic cancer (OR, 6.73 vs. other sites; P less than .0001] and a baseline dysphagia score of 0-1 vs. 2-4 (OR, 2.11; P = .004). Both were also highly predictive for late severe dysphagia at 12 months.
Data Source: A phase III, prospective, randomized, multicenter trial of 1,468 patients undergoing accelerated or conventional radiotherapy for squamous cell head and neck carcinoma.
Disclosures: The DAHANCA 6&7 trial was supported by the Danish Cancer Society, Åarhus University Hospital, Copenhagen University Hospital, Herlev University Hospital, Odense University Hospital, Aalborg Hospital. Dr. Mortensen had no personal financial disclosures to declare.
Smoking Cessation Can Reduce Late Side Effects of Radiotherapy
LONDON – One-third of current smokers with head and neck cancer experienced substantial difficulties in swallowing 1 year after radiotherapy, according to the results of a Danish study.
In comparison, 20% of ex-smokers and just 10% of never-smokers experienced dysphagia as a late-occurring side effect. Current smoking also was linked to higher rates of mucosal edema, atrophy, fibrosis, dry mouth, and hoarseness or loss of voice compared with outcomes in ex- and never-smokers.
These findings highlight the importance of smoking cessation before and even during treatment, said Dorthe Wiinholdt, M.P.H., a radiotherapy technician nurse from Copenhagen University Hospital.
"As nurses, we see patients every day with side effects during treatment," she said May 9 at the European Society for Therapeutic Radiation Oncology Anniversary Conference. "We talk to them about quitting smoking before treatment, because we know that smoking has an influence on efficacy and quality of life, and [in this study] we wanted to know if there was anything that patients could do for themselves to decrease the severity of these side effects."
To examine the influence of smoking on late side effects commonly associated with radiotherapy, Ms. Wiinholdt and her colleagues used prospectively collected data from the Danish Head and Neck Cancer Study Group (DAHANCA)’s database.
Between January 2000 and March 2009, they identified 578 men and 217 women with head and neck cancer who had been treated with radiotherapy at Copenhagen University Hospital. The mean age of patients was 60 years.
Treatment consisted of 66-68 Gy for carcinoma of the larynx, pharynx, and oral cavity, with less than 10% receiving concomitant chemotherapy. In the majority (84%) of cases, treatment was intended to cure the cancer.
Before starting treatment, 60 (7.5%) patients were identified as never-smokers, with 290 (36.5%) defined as ex-smokers and the remaining 445 (56%) as current smokers. "Sixty percent of patients quit smoking during treatment, but one-third resumed smoking after treatment," Ms. Wiinholdt reported.
Of the six side effects associated with head and neck radiotherapy included in the analysis, dysphagia and mucosal edema were the most significant in relation to smoking.
Dysphagia occurred in 34% of current smokers, 21% of ex-smokers, and 15% of never-smokers 6 months after stopping radiotherapy, and in 31%, 20%, and 10%, respectively, 1 year after treatment cessation. Corresponding figures for mucosal edema were 25%, 19%, and 10% at 6 months, and 22%, 14%, and 5% at 1 year.
With never-smokers as the reference group, the odds ratios (OR) were 4.3 (P = .02) for the association between smoking and dysphagia and 4.2 (P = .01) for smoking and mucosal edema after 12 months.
"We also saw a significant correlation between daily tobacco use and the number of moderate to severe side effects," Ms. Wiinholdt noted, with respective odds ratios at 6 and 12 months of 2.71 (P = .006) and 2.54 (P = .009).
Importantly, quitting smoking during treatment was found to significantly reduce the severity of voice changes (OR, 1.78; P =.04) and mucosal edema (OR, 1.89; P = .03) after 6 months.
"These findings back up our advice that patients should stop smoking," Ms. Wiinholdt suggested. They not only emphasize the importance of quitting smoking before starting treatment, she added, but also highlight the continued need to support patients with smoking cessation initiatives during treatment.
Ms. Wiinholdt had no financial conflicts of interest.
LONDON – One-third of current smokers with head and neck cancer experienced substantial difficulties in swallowing 1 year after radiotherapy, according to the results of a Danish study.
In comparison, 20% of ex-smokers and just 10% of never-smokers experienced dysphagia as a late-occurring side effect. Current smoking also was linked to higher rates of mucosal edema, atrophy, fibrosis, dry mouth, and hoarseness or loss of voice compared with outcomes in ex- and never-smokers.
These findings highlight the importance of smoking cessation before and even during treatment, said Dorthe Wiinholdt, M.P.H., a radiotherapy technician nurse from Copenhagen University Hospital.
"As nurses, we see patients every day with side effects during treatment," she said May 9 at the European Society for Therapeutic Radiation Oncology Anniversary Conference. "We talk to them about quitting smoking before treatment, because we know that smoking has an influence on efficacy and quality of life, and [in this study] we wanted to know if there was anything that patients could do for themselves to decrease the severity of these side effects."
To examine the influence of smoking on late side effects commonly associated with radiotherapy, Ms. Wiinholdt and her colleagues used prospectively collected data from the Danish Head and Neck Cancer Study Group (DAHANCA)’s database.
Between January 2000 and March 2009, they identified 578 men and 217 women with head and neck cancer who had been treated with radiotherapy at Copenhagen University Hospital. The mean age of patients was 60 years.
Treatment consisted of 66-68 Gy for carcinoma of the larynx, pharynx, and oral cavity, with less than 10% receiving concomitant chemotherapy. In the majority (84%) of cases, treatment was intended to cure the cancer.
Before starting treatment, 60 (7.5%) patients were identified as never-smokers, with 290 (36.5%) defined as ex-smokers and the remaining 445 (56%) as current smokers. "Sixty percent of patients quit smoking during treatment, but one-third resumed smoking after treatment," Ms. Wiinholdt reported.
Of the six side effects associated with head and neck radiotherapy included in the analysis, dysphagia and mucosal edema were the most significant in relation to smoking.
Dysphagia occurred in 34% of current smokers, 21% of ex-smokers, and 15% of never-smokers 6 months after stopping radiotherapy, and in 31%, 20%, and 10%, respectively, 1 year after treatment cessation. Corresponding figures for mucosal edema were 25%, 19%, and 10% at 6 months, and 22%, 14%, and 5% at 1 year.
With never-smokers as the reference group, the odds ratios (OR) were 4.3 (P = .02) for the association between smoking and dysphagia and 4.2 (P = .01) for smoking and mucosal edema after 12 months.
"We also saw a significant correlation between daily tobacco use and the number of moderate to severe side effects," Ms. Wiinholdt noted, with respective odds ratios at 6 and 12 months of 2.71 (P = .006) and 2.54 (P = .009).
Importantly, quitting smoking during treatment was found to significantly reduce the severity of voice changes (OR, 1.78; P =.04) and mucosal edema (OR, 1.89; P = .03) after 6 months.
"These findings back up our advice that patients should stop smoking," Ms. Wiinholdt suggested. They not only emphasize the importance of quitting smoking before starting treatment, she added, but also highlight the continued need to support patients with smoking cessation initiatives during treatment.
Ms. Wiinholdt had no financial conflicts of interest.
LONDON – One-third of current smokers with head and neck cancer experienced substantial difficulties in swallowing 1 year after radiotherapy, according to the results of a Danish study.
In comparison, 20% of ex-smokers and just 10% of never-smokers experienced dysphagia as a late-occurring side effect. Current smoking also was linked to higher rates of mucosal edema, atrophy, fibrosis, dry mouth, and hoarseness or loss of voice compared with outcomes in ex- and never-smokers.
These findings highlight the importance of smoking cessation before and even during treatment, said Dorthe Wiinholdt, M.P.H., a radiotherapy technician nurse from Copenhagen University Hospital.
"As nurses, we see patients every day with side effects during treatment," she said May 9 at the European Society for Therapeutic Radiation Oncology Anniversary Conference. "We talk to them about quitting smoking before treatment, because we know that smoking has an influence on efficacy and quality of life, and [in this study] we wanted to know if there was anything that patients could do for themselves to decrease the severity of these side effects."
To examine the influence of smoking on late side effects commonly associated with radiotherapy, Ms. Wiinholdt and her colleagues used prospectively collected data from the Danish Head and Neck Cancer Study Group (DAHANCA)’s database.
Between January 2000 and March 2009, they identified 578 men and 217 women with head and neck cancer who had been treated with radiotherapy at Copenhagen University Hospital. The mean age of patients was 60 years.
Treatment consisted of 66-68 Gy for carcinoma of the larynx, pharynx, and oral cavity, with less than 10% receiving concomitant chemotherapy. In the majority (84%) of cases, treatment was intended to cure the cancer.
Before starting treatment, 60 (7.5%) patients were identified as never-smokers, with 290 (36.5%) defined as ex-smokers and the remaining 445 (56%) as current smokers. "Sixty percent of patients quit smoking during treatment, but one-third resumed smoking after treatment," Ms. Wiinholdt reported.
Of the six side effects associated with head and neck radiotherapy included in the analysis, dysphagia and mucosal edema were the most significant in relation to smoking.
Dysphagia occurred in 34% of current smokers, 21% of ex-smokers, and 15% of never-smokers 6 months after stopping radiotherapy, and in 31%, 20%, and 10%, respectively, 1 year after treatment cessation. Corresponding figures for mucosal edema were 25%, 19%, and 10% at 6 months, and 22%, 14%, and 5% at 1 year.
With never-smokers as the reference group, the odds ratios (OR) were 4.3 (P = .02) for the association between smoking and dysphagia and 4.2 (P = .01) for smoking and mucosal edema after 12 months.
"We also saw a significant correlation between daily tobacco use and the number of moderate to severe side effects," Ms. Wiinholdt noted, with respective odds ratios at 6 and 12 months of 2.71 (P = .006) and 2.54 (P = .009).
Importantly, quitting smoking during treatment was found to significantly reduce the severity of voice changes (OR, 1.78; P =.04) and mucosal edema (OR, 1.89; P = .03) after 6 months.
"These findings back up our advice that patients should stop smoking," Ms. Wiinholdt suggested. They not only emphasize the importance of quitting smoking before starting treatment, she added, but also highlight the continued need to support patients with smoking cessation initiatives during treatment.
Ms. Wiinholdt had no financial conflicts of interest.
FROM THE EUROPEAN SOCIETY FOR THERAPEUTIC RADIATION ONCOLOY ANNIVERSARY CONFERENCE
GMajor Finding: Dysphagia occurred in 34% of current smokers, 21% of ex-smokers, and 15% of never-smokers 6 months after stopping radiotherapy, and in 31%, 20%, and 10%, respectively, 1 year after treatment cessation.
Data Source: Epidemiologic study of 795 patients undergoing radiotherapy for head and neck cancer.
Disclosures: Ms. Wiinholdt had no financial conflicts of interest.
BRAF Mutation Status May Change Papillary Thyroid Cancer Management
NEW ORLEANS – BRAF mutation is a valuable molecular marker for worse clinicopathological outcomes in papillary thyroid cancer – one that will be useful preoperatively in risk stratification and decision making, according to a leading investigator in this area, Dr. Michael Mingzhao Xing.
"BRAF mutation, as a prognostic marker, could be particularly helpful in some of the more controversial areas related to the management of PTC [papillary thyroid cancer], such as areas where current standard guidelines may not give clear guidance," Dr. Xing suggested at the symposium on thyroid and parathyroid diseases, which was sponsored by Tulane University.
Although Dr. Xing, chief of the laboratory for cellular and molecular thyroid research at Johns Hopkins University in Baltimore, advocated strongly for the potential of BRAF to guide treatment, he added that its routine use still needs to be specifically defined..
The T1799A mutation in BRAF, a kinase in the MPA kinase signaling pathway, leads to uncontrolled cell growth, unlimited cell proliferation, and – ultimately – tumorigenesis, he said. It is most common in PTC (44%), and to a lesser degree in anaplastic thyroid carcinoma (24%), according to his series of nearly 2,000 tumors (Endocr. Relat. Cancer 2005;12:245-62). The mutation was not found in any medullary thyroid carcinomas or follicular thyroid carcinomas.
Among the subtypes of PTC, the mutation was present in 77% of tall-cell PTCs, 60% of conventional PTCs, and 12% of follicular-variant PTCs.
Multiple Studies Are Consistent
In a multicenter study of 219 patients by Dr. Xing and colleagues, the association between BRAF mutation and clinical aggressiveness was clear. Extrathyroidal invasion was observed in 41% of BRAF-positive patients, compared with 16% of BRAF-negative patients, whereas lymph node metastases occurred in 54% and 21%, respectively (both P less than .001) (J. Clin. Endocrinol. Metab. 2005;90:6373-9).
Other associations were seen between the mutation and advanced tumor stage (P = .007) and tumor recurrence (P = .004). Age at diagnosis, sex, tumor size, and multifocality were not consistently related to mutation status, he added.
This more-aggressive clinicopathological picture translated into significantly more recurrences among BRAF-positive patients in the study at 9 years (25% vs. 9%, for a threefold increase in risk; P = .03). BRAF mutation was even an independent and stronger predictor of recurrence in patients with stage I and II disease (22% vs. 5%, respectively; P = .002).
A Korean study also calculated an odds ratio of 4.6 for recurrence in the presence of the BRAF mutation (P = 0.037), although statistical significance was lost in a multivariate model (Clin. Endocrinol. 2006;65:364-8). In a 2008 study performed in the Middle East, BRAF mutation was associated with metastasis (P = .0274) and poor disease-free survival (P = .0121). A meta-analysis validated the association of the BRAF mutation with extrathyroidal invasion, lymph node metastasis, and advanced stage (Endocr. Rev. 2007;28:742-62).
Dr. Xing noted the universality of the association: "Among studies of patients with a variety of ethnic backgrounds, there is a strong association with disease recurrence," he observed.
Low-Risk Patients Rendered High Risk
Even in populations that are conventionally considered at low risk for recurrence, the BRAF mutation is not uncommon, Dr. Xing said, citing prevalence figures of 36% among stage I and II PTC patients, and 18%-24% among papillary thyroid microcarcinoma (PTMC) patients. In these low-risk populations, aggressive features and recurrence are associated with BRAF positivity.
In studies of stage I and II patients and others with PTMC, BRAF-positive patients were three to four times more likely to have extrathyroidal extension, lymph node metastasis, and advanced disease (Ann. Surg. Oncol. 2009;16:240-5). One study of stage I and II patients found the odds ratio for recurrence to be 11.4 (P = .004) "with adjustment for conventional clinicopathological factors and radioiodine treatment." (J. Clin. Endocrinol. Metab. 2005;90:6373-9).
Other Concerning Associations
Importantly, BRAF mutations are associated with a loss of radioiodine avidity in recurrent PTC, "which means the patient may not respond to radioactive iodine treatment," he said. Dr. Xing has observed a loss of avidity in 54% of patients with the mutation, but in none of the patients who lacked the BRAF mutation.
Dr. David S. Cooper, professor of medicine at Johns Hopkins and former president of the American Thyroid Association, commented on this issue during the discussion. "Knowing beforehand when a patient is BRAF positive may inform our aggressiveness with regard to surgery, [that is,] central neck dissection," he said.
"And there is the thought that because [such cancers] are more aggressive, we will be more likely to treat with radioactive iodine. The BRAF mutation also confers the inability to take up radioactive iodine, though, so this is not necessarily going to be the case." However, radioiodine treatment to ablate residual normal thyroid tissue may be more important in BRAF mutation–positive patients, as it can enhance the reliability of serum thyroglobulin testing for the surveillance of thyroid cancer recurrence in these patients who may need more vigilant monitoring because of the increased aggressiveness of their cancer.
Also of concern is the finding that these patients are likely to require additional surgery. "We were the first to show a higher need for reoperation," Dr. Xing noted.
In his 2005 series, 69% of BRAF-positive patients required more aggressive treatment (additional surgery or external radiation), compared with 14% of BRAF-negative patients (J. Clin. Endocrinol. Metab. 2005;90:6373-9).
Other recent studies have shown the same (Surgery 2010;148:1139-46). In a study at the University of Pittsburgh, the investigators determined that preoperative knowledge of BRAF mutation positivity could have productively altered the initial PTC surgical management in 24% of patients (Surgery 2009;146:1215-23).
Testing Biopsy for BRAF Mutation
"If you have the results of BRAF testing preoperatively, they can help with risk stratification and surgical planning," Dr. Xing said.
In a 2010 study, researchers analyzed the utility of BRAF mutation screening of 61 fine-needle aspiration biopsy (FNAB) specimens for predicting aggressive clinicopathological characteristics of PTMC (Ann. Surg. Oncol. 2010;17:3294-300). The BRAF mutation was significantly associated with multifocality, extrathyroidal invasion, lateral lymph-node metastasis (LNM) and advanced tumor stages. In a multivariate analysis, the BRAF mutation carried an odds ratio of 18 for central LNM (P = .01). The authors concluded that BRAF mutation screening of FNAB specimens can be used to predict aggressive clinicopathological characteristics of PTMC, and that lateral neck nodes should be meticulously analyzed for cases of PTMC demonstrating mutated BRAF.
These results were consistent with those of an earlier study in which Dr. Xing and colleagues calculated odds ratios to show the predictive power of BRAF mutations found in FNAB specimens to preoperatively risk-stratify PTC patients (J. Clin. Oncol. 2009;27:2977-82). (See box.) The positive predictive value of BRAF mutation status was 36%, and the negative predictive value was 88%.
In summary, Dr. Xing emphasized that the BRAF mutation plays a critical role in PTC tumorigenesis and aggressiveness and can be used preoperatively to risk-stratify patients and assist the physician in planning treatment. He joked to attendees: "Send your patients to me first, before you treat, to check for the mutation."
Dr. Xing reported receiving royalties as a coholder of a licensed patent on the discovery of BRAF mutation and its clinical characterization in thyroid cancer.
NEW ORLEANS – BRAF mutation is a valuable molecular marker for worse clinicopathological outcomes in papillary thyroid cancer – one that will be useful preoperatively in risk stratification and decision making, according to a leading investigator in this area, Dr. Michael Mingzhao Xing.
"BRAF mutation, as a prognostic marker, could be particularly helpful in some of the more controversial areas related to the management of PTC [papillary thyroid cancer], such as areas where current standard guidelines may not give clear guidance," Dr. Xing suggested at the symposium on thyroid and parathyroid diseases, which was sponsored by Tulane University.
Although Dr. Xing, chief of the laboratory for cellular and molecular thyroid research at Johns Hopkins University in Baltimore, advocated strongly for the potential of BRAF to guide treatment, he added that its routine use still needs to be specifically defined..
The T1799A mutation in BRAF, a kinase in the MPA kinase signaling pathway, leads to uncontrolled cell growth, unlimited cell proliferation, and – ultimately – tumorigenesis, he said. It is most common in PTC (44%), and to a lesser degree in anaplastic thyroid carcinoma (24%), according to his series of nearly 2,000 tumors (Endocr. Relat. Cancer 2005;12:245-62). The mutation was not found in any medullary thyroid carcinomas or follicular thyroid carcinomas.
Among the subtypes of PTC, the mutation was present in 77% of tall-cell PTCs, 60% of conventional PTCs, and 12% of follicular-variant PTCs.
Multiple Studies Are Consistent
In a multicenter study of 219 patients by Dr. Xing and colleagues, the association between BRAF mutation and clinical aggressiveness was clear. Extrathyroidal invasion was observed in 41% of BRAF-positive patients, compared with 16% of BRAF-negative patients, whereas lymph node metastases occurred in 54% and 21%, respectively (both P less than .001) (J. Clin. Endocrinol. Metab. 2005;90:6373-9).
Other associations were seen between the mutation and advanced tumor stage (P = .007) and tumor recurrence (P = .004). Age at diagnosis, sex, tumor size, and multifocality were not consistently related to mutation status, he added.
This more-aggressive clinicopathological picture translated into significantly more recurrences among BRAF-positive patients in the study at 9 years (25% vs. 9%, for a threefold increase in risk; P = .03). BRAF mutation was even an independent and stronger predictor of recurrence in patients with stage I and II disease (22% vs. 5%, respectively; P = .002).
A Korean study also calculated an odds ratio of 4.6 for recurrence in the presence of the BRAF mutation (P = 0.037), although statistical significance was lost in a multivariate model (Clin. Endocrinol. 2006;65:364-8). In a 2008 study performed in the Middle East, BRAF mutation was associated with metastasis (P = .0274) and poor disease-free survival (P = .0121). A meta-analysis validated the association of the BRAF mutation with extrathyroidal invasion, lymph node metastasis, and advanced stage (Endocr. Rev. 2007;28:742-62).
Dr. Xing noted the universality of the association: "Among studies of patients with a variety of ethnic backgrounds, there is a strong association with disease recurrence," he observed.
Low-Risk Patients Rendered High Risk
Even in populations that are conventionally considered at low risk for recurrence, the BRAF mutation is not uncommon, Dr. Xing said, citing prevalence figures of 36% among stage I and II PTC patients, and 18%-24% among papillary thyroid microcarcinoma (PTMC) patients. In these low-risk populations, aggressive features and recurrence are associated with BRAF positivity.
In studies of stage I and II patients and others with PTMC, BRAF-positive patients were three to four times more likely to have extrathyroidal extension, lymph node metastasis, and advanced disease (Ann. Surg. Oncol. 2009;16:240-5). One study of stage I and II patients found the odds ratio for recurrence to be 11.4 (P = .004) "with adjustment for conventional clinicopathological factors and radioiodine treatment." (J. Clin. Endocrinol. Metab. 2005;90:6373-9).
Other Concerning Associations
Importantly, BRAF mutations are associated with a loss of radioiodine avidity in recurrent PTC, "which means the patient may not respond to radioactive iodine treatment," he said. Dr. Xing has observed a loss of avidity in 54% of patients with the mutation, but in none of the patients who lacked the BRAF mutation.
Dr. David S. Cooper, professor of medicine at Johns Hopkins and former president of the American Thyroid Association, commented on this issue during the discussion. "Knowing beforehand when a patient is BRAF positive may inform our aggressiveness with regard to surgery, [that is,] central neck dissection," he said.
"And there is the thought that because [such cancers] are more aggressive, we will be more likely to treat with radioactive iodine. The BRAF mutation also confers the inability to take up radioactive iodine, though, so this is not necessarily going to be the case." However, radioiodine treatment to ablate residual normal thyroid tissue may be more important in BRAF mutation–positive patients, as it can enhance the reliability of serum thyroglobulin testing for the surveillance of thyroid cancer recurrence in these patients who may need more vigilant monitoring because of the increased aggressiveness of their cancer.
Also of concern is the finding that these patients are likely to require additional surgery. "We were the first to show a higher need for reoperation," Dr. Xing noted.
In his 2005 series, 69% of BRAF-positive patients required more aggressive treatment (additional surgery or external radiation), compared with 14% of BRAF-negative patients (J. Clin. Endocrinol. Metab. 2005;90:6373-9).
Other recent studies have shown the same (Surgery 2010;148:1139-46). In a study at the University of Pittsburgh, the investigators determined that preoperative knowledge of BRAF mutation positivity could have productively altered the initial PTC surgical management in 24% of patients (Surgery 2009;146:1215-23).
Testing Biopsy for BRAF Mutation
"If you have the results of BRAF testing preoperatively, they can help with risk stratification and surgical planning," Dr. Xing said.
In a 2010 study, researchers analyzed the utility of BRAF mutation screening of 61 fine-needle aspiration biopsy (FNAB) specimens for predicting aggressive clinicopathological characteristics of PTMC (Ann. Surg. Oncol. 2010;17:3294-300). The BRAF mutation was significantly associated with multifocality, extrathyroidal invasion, lateral lymph-node metastasis (LNM) and advanced tumor stages. In a multivariate analysis, the BRAF mutation carried an odds ratio of 18 for central LNM (P = .01). The authors concluded that BRAF mutation screening of FNAB specimens can be used to predict aggressive clinicopathological characteristics of PTMC, and that lateral neck nodes should be meticulously analyzed for cases of PTMC demonstrating mutated BRAF.
These results were consistent with those of an earlier study in which Dr. Xing and colleagues calculated odds ratios to show the predictive power of BRAF mutations found in FNAB specimens to preoperatively risk-stratify PTC patients (J. Clin. Oncol. 2009;27:2977-82). (See box.) The positive predictive value of BRAF mutation status was 36%, and the negative predictive value was 88%.
In summary, Dr. Xing emphasized that the BRAF mutation plays a critical role in PTC tumorigenesis and aggressiveness and can be used preoperatively to risk-stratify patients and assist the physician in planning treatment. He joked to attendees: "Send your patients to me first, before you treat, to check for the mutation."
Dr. Xing reported receiving royalties as a coholder of a licensed patent on the discovery of BRAF mutation and its clinical characterization in thyroid cancer.
NEW ORLEANS – BRAF mutation is a valuable molecular marker for worse clinicopathological outcomes in papillary thyroid cancer – one that will be useful preoperatively in risk stratification and decision making, according to a leading investigator in this area, Dr. Michael Mingzhao Xing.
"BRAF mutation, as a prognostic marker, could be particularly helpful in some of the more controversial areas related to the management of PTC [papillary thyroid cancer], such as areas where current standard guidelines may not give clear guidance," Dr. Xing suggested at the symposium on thyroid and parathyroid diseases, which was sponsored by Tulane University.
Although Dr. Xing, chief of the laboratory for cellular and molecular thyroid research at Johns Hopkins University in Baltimore, advocated strongly for the potential of BRAF to guide treatment, he added that its routine use still needs to be specifically defined..
The T1799A mutation in BRAF, a kinase in the MPA kinase signaling pathway, leads to uncontrolled cell growth, unlimited cell proliferation, and – ultimately – tumorigenesis, he said. It is most common in PTC (44%), and to a lesser degree in anaplastic thyroid carcinoma (24%), according to his series of nearly 2,000 tumors (Endocr. Relat. Cancer 2005;12:245-62). The mutation was not found in any medullary thyroid carcinomas or follicular thyroid carcinomas.
Among the subtypes of PTC, the mutation was present in 77% of tall-cell PTCs, 60% of conventional PTCs, and 12% of follicular-variant PTCs.
Multiple Studies Are Consistent
In a multicenter study of 219 patients by Dr. Xing and colleagues, the association between BRAF mutation and clinical aggressiveness was clear. Extrathyroidal invasion was observed in 41% of BRAF-positive patients, compared with 16% of BRAF-negative patients, whereas lymph node metastases occurred in 54% and 21%, respectively (both P less than .001) (J. Clin. Endocrinol. Metab. 2005;90:6373-9).
Other associations were seen between the mutation and advanced tumor stage (P = .007) and tumor recurrence (P = .004). Age at diagnosis, sex, tumor size, and multifocality were not consistently related to mutation status, he added.
This more-aggressive clinicopathological picture translated into significantly more recurrences among BRAF-positive patients in the study at 9 years (25% vs. 9%, for a threefold increase in risk; P = .03). BRAF mutation was even an independent and stronger predictor of recurrence in patients with stage I and II disease (22% vs. 5%, respectively; P = .002).
A Korean study also calculated an odds ratio of 4.6 for recurrence in the presence of the BRAF mutation (P = 0.037), although statistical significance was lost in a multivariate model (Clin. Endocrinol. 2006;65:364-8). In a 2008 study performed in the Middle East, BRAF mutation was associated with metastasis (P = .0274) and poor disease-free survival (P = .0121). A meta-analysis validated the association of the BRAF mutation with extrathyroidal invasion, lymph node metastasis, and advanced stage (Endocr. Rev. 2007;28:742-62).
Dr. Xing noted the universality of the association: "Among studies of patients with a variety of ethnic backgrounds, there is a strong association with disease recurrence," he observed.
Low-Risk Patients Rendered High Risk
Even in populations that are conventionally considered at low risk for recurrence, the BRAF mutation is not uncommon, Dr. Xing said, citing prevalence figures of 36% among stage I and II PTC patients, and 18%-24% among papillary thyroid microcarcinoma (PTMC) patients. In these low-risk populations, aggressive features and recurrence are associated with BRAF positivity.
In studies of stage I and II patients and others with PTMC, BRAF-positive patients were three to four times more likely to have extrathyroidal extension, lymph node metastasis, and advanced disease (Ann. Surg. Oncol. 2009;16:240-5). One study of stage I and II patients found the odds ratio for recurrence to be 11.4 (P = .004) "with adjustment for conventional clinicopathological factors and radioiodine treatment." (J. Clin. Endocrinol. Metab. 2005;90:6373-9).
Other Concerning Associations
Importantly, BRAF mutations are associated with a loss of radioiodine avidity in recurrent PTC, "which means the patient may not respond to radioactive iodine treatment," he said. Dr. Xing has observed a loss of avidity in 54% of patients with the mutation, but in none of the patients who lacked the BRAF mutation.
Dr. David S. Cooper, professor of medicine at Johns Hopkins and former president of the American Thyroid Association, commented on this issue during the discussion. "Knowing beforehand when a patient is BRAF positive may inform our aggressiveness with regard to surgery, [that is,] central neck dissection," he said.
"And there is the thought that because [such cancers] are more aggressive, we will be more likely to treat with radioactive iodine. The BRAF mutation also confers the inability to take up radioactive iodine, though, so this is not necessarily going to be the case." However, radioiodine treatment to ablate residual normal thyroid tissue may be more important in BRAF mutation–positive patients, as it can enhance the reliability of serum thyroglobulin testing for the surveillance of thyroid cancer recurrence in these patients who may need more vigilant monitoring because of the increased aggressiveness of their cancer.
Also of concern is the finding that these patients are likely to require additional surgery. "We were the first to show a higher need for reoperation," Dr. Xing noted.
In his 2005 series, 69% of BRAF-positive patients required more aggressive treatment (additional surgery or external radiation), compared with 14% of BRAF-negative patients (J. Clin. Endocrinol. Metab. 2005;90:6373-9).
Other recent studies have shown the same (Surgery 2010;148:1139-46). In a study at the University of Pittsburgh, the investigators determined that preoperative knowledge of BRAF mutation positivity could have productively altered the initial PTC surgical management in 24% of patients (Surgery 2009;146:1215-23).
Testing Biopsy for BRAF Mutation
"If you have the results of BRAF testing preoperatively, they can help with risk stratification and surgical planning," Dr. Xing said.
In a 2010 study, researchers analyzed the utility of BRAF mutation screening of 61 fine-needle aspiration biopsy (FNAB) specimens for predicting aggressive clinicopathological characteristics of PTMC (Ann. Surg. Oncol. 2010;17:3294-300). The BRAF mutation was significantly associated with multifocality, extrathyroidal invasion, lateral lymph-node metastasis (LNM) and advanced tumor stages. In a multivariate analysis, the BRAF mutation carried an odds ratio of 18 for central LNM (P = .01). The authors concluded that BRAF mutation screening of FNAB specimens can be used to predict aggressive clinicopathological characteristics of PTMC, and that lateral neck nodes should be meticulously analyzed for cases of PTMC demonstrating mutated BRAF.
These results were consistent with those of an earlier study in which Dr. Xing and colleagues calculated odds ratios to show the predictive power of BRAF mutations found in FNAB specimens to preoperatively risk-stratify PTC patients (J. Clin. Oncol. 2009;27:2977-82). (See box.) The positive predictive value of BRAF mutation status was 36%, and the negative predictive value was 88%.
In summary, Dr. Xing emphasized that the BRAF mutation plays a critical role in PTC tumorigenesis and aggressiveness and can be used preoperatively to risk-stratify patients and assist the physician in planning treatment. He joked to attendees: "Send your patients to me first, before you treat, to check for the mutation."
Dr. Xing reported receiving royalties as a coholder of a licensed patent on the discovery of BRAF mutation and its clinical characterization in thyroid cancer.
EXPERT ANALYSIS FROM A SYMPOSIUM ON THYROID AND PARATHYROID DISEASES
FDA Approves First Drug for Medullary Thyroid Cancer
The Food and Drug Administration on April 6 approved vandetanib for the treatment of metastatic medullary thyroid cancer in adults – making it the first drug approved for this rare cancer.
Vandetanib is indicated for adults with metastatic medullary thyroid cancer, "who are ineligible for surgery and who have disease that is growing or causing symptoms," the agency said. It is administered orally once a day.
Approval was based on an international phase III study that compared treatment with oral vandetanib, 300 mg once a day, with placebo in 331 patients with unresectable locally advanced or metastatic medically thyroid cancer. The risk of progression with vandetanib was reduced by 54%, compared with placebo, a significant effect.
Among those on placebo, median progression-free survival was 16.4 months, compared with at least 22.6 months among those on vandetanib, according to the FDA statement, which added: "It is too early to determine the median progression-free survival in patients treated with vandetanib or to tell whether they will live longer (overall survival) compared to patients treated with placebo." Diarrhea, rash, nausea, high blood pressure, headache, fatigue, decreased appetite, and abdominal pain were among the adverse effects associated with treatment. In the study, serious adverse events resulted in five deaths in patients treated with vandetanib, according to the FDA; causes included breathing complications, heart failure, and sepsis.
Because vandetanib can cause QT interval prolongation, it is being approved with a Risk Evaluation and Mitigation Strategy (REMS) to inform health care professionals about cardiac risks and will be available through a restricted distribution program, so that only health care professionals and pharmacies certified through the vandetanib REMS program will be able to prescribe and dispense the product. Patients also will be given a medication guide that explains the risks of treatment.
An estimated 3%-5% of all thyroid cancers are medullary thyroid cancer, and the incidence of this cancer in the United States in 2010 was about 1,300-2,200 patients, according to the FDA.
There is no trade name yet for the drug, manufactured by AstraZeneca Pharmaceuticals.
The Food and Drug Administration on April 6 approved vandetanib for the treatment of metastatic medullary thyroid cancer in adults – making it the first drug approved for this rare cancer.
Vandetanib is indicated for adults with metastatic medullary thyroid cancer, "who are ineligible for surgery and who have disease that is growing or causing symptoms," the agency said. It is administered orally once a day.
Approval was based on an international phase III study that compared treatment with oral vandetanib, 300 mg once a day, with placebo in 331 patients with unresectable locally advanced or metastatic medically thyroid cancer. The risk of progression with vandetanib was reduced by 54%, compared with placebo, a significant effect.
Among those on placebo, median progression-free survival was 16.4 months, compared with at least 22.6 months among those on vandetanib, according to the FDA statement, which added: "It is too early to determine the median progression-free survival in patients treated with vandetanib or to tell whether they will live longer (overall survival) compared to patients treated with placebo." Diarrhea, rash, nausea, high blood pressure, headache, fatigue, decreased appetite, and abdominal pain were among the adverse effects associated with treatment. In the study, serious adverse events resulted in five deaths in patients treated with vandetanib, according to the FDA; causes included breathing complications, heart failure, and sepsis.
Because vandetanib can cause QT interval prolongation, it is being approved with a Risk Evaluation and Mitigation Strategy (REMS) to inform health care professionals about cardiac risks and will be available through a restricted distribution program, so that only health care professionals and pharmacies certified through the vandetanib REMS program will be able to prescribe and dispense the product. Patients also will be given a medication guide that explains the risks of treatment.
An estimated 3%-5% of all thyroid cancers are medullary thyroid cancer, and the incidence of this cancer in the United States in 2010 was about 1,300-2,200 patients, according to the FDA.
There is no trade name yet for the drug, manufactured by AstraZeneca Pharmaceuticals.
The Food and Drug Administration on April 6 approved vandetanib for the treatment of metastatic medullary thyroid cancer in adults – making it the first drug approved for this rare cancer.
Vandetanib is indicated for adults with metastatic medullary thyroid cancer, "who are ineligible for surgery and who have disease that is growing or causing symptoms," the agency said. It is administered orally once a day.
Approval was based on an international phase III study that compared treatment with oral vandetanib, 300 mg once a day, with placebo in 331 patients with unresectable locally advanced or metastatic medically thyroid cancer. The risk of progression with vandetanib was reduced by 54%, compared with placebo, a significant effect.
Among those on placebo, median progression-free survival was 16.4 months, compared with at least 22.6 months among those on vandetanib, according to the FDA statement, which added: "It is too early to determine the median progression-free survival in patients treated with vandetanib or to tell whether they will live longer (overall survival) compared to patients treated with placebo." Diarrhea, rash, nausea, high blood pressure, headache, fatigue, decreased appetite, and abdominal pain were among the adverse effects associated with treatment. In the study, serious adverse events resulted in five deaths in patients treated with vandetanib, according to the FDA; causes included breathing complications, heart failure, and sepsis.
Because vandetanib can cause QT interval prolongation, it is being approved with a Risk Evaluation and Mitigation Strategy (REMS) to inform health care professionals about cardiac risks and will be available through a restricted distribution program, so that only health care professionals and pharmacies certified through the vandetanib REMS program will be able to prescribe and dispense the product. Patients also will be given a medication guide that explains the risks of treatment.
An estimated 3%-5% of all thyroid cancers are medullary thyroid cancer, and the incidence of this cancer in the United States in 2010 was about 1,300-2,200 patients, according to the FDA.
There is no trade name yet for the drug, manufactured by AstraZeneca Pharmaceuticals.
FROM THE FOOD AND DRUG ADMINISTRATION
Feasibility and acceptance of a telehealth intervention to promote symptom management during treatment for head and neck cancer
Treatment for head and neck cancer is most often a rigorous regimen of combination therapies, producing a multitude of distressing symptoms and side effects. While it is nearly impossible to circumvent the physical and psychosocial insults caused by such treatment, some interventions directed toward educating and supporting patients during active treatment have met with success.[1], [2], [3] and [4] Conversely, other efforts have demonstrated little impact[5] and [6] or have been poorly received,7 pointing to the need for effective, acceptable means to provide support during such difficult treatment.
Over the past 10 years, telemedicine technology has enabled innovative approaches for improving patient education, assessment, support, and communication during treatment for both acute and chronic diseases. A recent policy white paper8 described telemedicine technology as including “the electronic acquisition, processing, dissemination, storage, retrieval, and exchange of information for the purpose of promoting health, preventing disease, treating the sick, managing chronic illness, rehabilitating the disabled, and protecting public health and safety” (p. 2). This same paper suggests that national telemedicine initiatives are essential to health-care reform based upon their proven cost–effectiveness and clinical efficacy. However, cost savings and clinical effectiveness will be unrealized outcomes if the interventions are not feasible in practice or acceptable to the targeted population.
In the arena of cancer care, telephone-based systems have been used to report and monitor cancer symptoms with favorable compliance noted even when patients are expected to initiate calls on a regular basis.[9], [10], [11] and [12] Favorable acceptance ratings have also been reported by both patients and clinicians regarding computerized systems used to assess symptoms and quality of life (QOL) in cancer patients.[13], [14], [15], [16], [17], [18] and [19] In the United Kingdom, a handheld computer system was successfully used to monitor and support patients receiving chemotherapy for lung or colorectal cancer,20 and a study testing a dialogic model of cancer care expecting patients to respond to telehealth messaging on a daily basis over 6 months reported an 84% cooperation rate.21 In these studies, the majority of patients reported ease of use and acceptability of the technology. Survey research has found both urban and rural cancer patients to be receptive to medical and psychiatric services provided via telehealth.22
Published reports describing use of telehealth and computerized interventions during head and neck cancer treatment are less prevalent. Touch-screen computers were successfully used in the Netherlands to collect QOL and distress data from head and neck cancer patients.16 Videoconferencing has been used successfully to overcome geographical barriers to patient assessment[23], [24] and [25] and to provide speech–language pathology services to people living with head and neck cancers in remote areas. Reported use of telehealth management appears promising for providing timely access to care for those who are geographically isolated.26
A research group based in the Netherlands developed and tested a comprehensive electronic health information support system for use in head and neck cancer care.27 The system had four patient-related functions: facilitating communication between patients and health-care providers, providing information about the disease and its treatment, connecting patients with other patients similarly diagnosed, and monitoring patients after hospital discharge. The system was found to be well-accepted and appreciated by participating patients, and its use enabled early identification and direct intervention for patient problems.27 A clinical trial of the telehealth application showed improved QOL in five of 22 studied parameters for the treatment group.28 However, 20 of the 59 patients eligible for the intervention group refused participation; 11 (55%) of these stated computer-related concerns as their reason for nonparticipation.
Knowing that head and neck cancer patients experience a high burden of illness and often have significant communication, socioeconomic, and geographic barriers to care, our team developed a telehealth intervention using a simple telemessaging device to circumvent communication barriers and perceived technical challenges associated with computer-based systems to provide education and support to patients in their own home and on their own time schedule.29 Overall, we hypothesized that patients receiving the intervention would experience less symptom distress, improved QOL, increased self-efficacy, and greater satisfaction with symptom management than those in the control group. However, as a first step toward examining the efficacy and effectiveness of this intervention, this study examined both quantitative and qualitative indicators of its feasibility and acceptance among patients undergoing treatment for head and neck cancer.
Methods
Design
Subsequent to study approval by the University of Louisville's Human Subjects Protection Office, a randomized clinical trial comparing the telehealth intervention to standard care was conducted using a two-group parallel design. This study reports on the intervention's feasibility and acceptance in the treatment group of 44 patients.
Site
Participants were recruited from patients receiving care from the Multidisciplinary Head and Neck Cancer Team at the James Graham Brown Cancer Center (JGBCC) over a 2-year period (June 2006 through June 2008). The team consisted of head and neck surgeons, medical oncologists, radiation oncologists, nurses, a pathologist, a speech therapist, a registered dietician, a psychologist, and a social worker. This team developed a comprehensive assessment and treatment plan during each patient's initial visit to the clinic and coordinated patient care throughout the treatment process.
Sample
Patients eligible for study participation met the following inclusion criteria: (1) initial diagnosis of head or neck cancer including cancers of the oral cavity, salivary glands, paranasal sinuses and nasal cavity, pharynx, and larynx; (2) involvement in a treatment plan including one or more modalities (ie, surgery, chemotherapy, radiation, or any combination); (3) capacity to give independent informed consent; and (4) ability to speak, read, and comprehend English at the eighth-grade level or above. Patients were excluded from participation if they had no land telephone line, had a thought disorder, were incarcerated, or had compromised cognitive functioning.
All patients scheduled for assessment received an explanation of the research study via print materials prior to their first clinic visit. During their first scheduled clinic visit, all patients identified as eligible were approached by a member of the research study staff, who briefly explained the study and asked if they might be interested in study participation. Because of the stress and content of this first clinic visit, interested patients were contacted later by phone to schedule an additional visit to review the study and obtain informed consent.
During the informed consent meeting, the study procedures were explained in detail. If the patient agreed and signed a consent form, a randomization grid which considered the patient's particular treatment plan was used to assign the patient to either the control or the experimental group. Baseline data were also collected during this first visit.
Description of the Intervention
The technology selected for implementing the intervention was the Health Buddy® System, a commercially available, proprietary system produced and maintained by Robert Bosch Healthcare Palo Alto, CA. The Health Buddy, the appliance used for interaction between the participant and the health-care provider, is a user-friendly, easily visible, electrical device that attaches to the user's land phone line (see Figure 1). Questions and information are displayed on the liquid crystal display (LCD) screen of the 6 × 9–inch appliance. The individual responds to questions by pressing one of the four large buttons below the screen. The research team selected the technology provider based on the ability of the technology to perform in accordance with the research objectives.
Symptom control algorithms developed using participatory action research (surveys of current and past patients and clinicians) and evidence-based practice were programmed into the telehealth messaging system (see article by Head et al,29 which details the algorithm topic selection and development process). The algorithms addressed 29 different symptoms and side effects of treatment, consisting of approximately 100 questions accompanied by related educational and supportive responses. Patients were asked three to five questions daily related to the symptoms anticipated during their treatment scenario. Depending upon their response, they would receive specific information related to symptom self-management, including recommendations as to when to contact their clinicians. The algorithms were constructed with the goal of encouraging self-efficacy and independent action on the part of the participant. See Figure 2 for an example of the branching algorithms.
Participants randomly assigned to the treatment group immediately had the Health Buddy connected to a land telephone line in their home. Most (40%) chose to place it in their kitchen, while another 26% placed it in their bedrooms; most often, it was in a highly visible location, serving to remind the participant to respond. Research study staff delivered, installed, and demonstrated how to operate the equipment. Installation was simple and required only minutes. A tutorial programmed into the Health Buddy taught participants how to reply to questions appearing on the monitor using the four large keys below the possible answers or a rating scale which would appear depending on the type of question asked.
During the early hours of the morning, the device would automatically call a toll-free number. Responses to the previous day's questions were uploaded, and questions and related information for the next day were downloaded over the telephone line onto a secure server. Phone service was never disrupted by the device; if the phone was in use, the system would connect later to retrieve and download information. Once new content was transferred, a green light on the device would flash to alert the participant that new questions were available for response. Once the participant pressed any of the keys, the new algorithms would begin appearing on the monitor screen.
Participants were instructed to begin responding on the first day they received treatment or on the first day after returning home from surgery. They were asked to continue responding daily (unless hospitalized for treatment) throughout the treatment period and for approximately 2 weeks posttreatment as treatment-induced symptoms continue during that period of time. Study staff contacted participants when treatment was complete and scheduled a date to pick up the appliance and end daily responding. Daily patient responses required 5–10 minutes.
Participant responses could be viewed by study staff via Internet access 1 day after being answered. Responses were monitored daily by study nurses. Symptoms unrelieved over time or symptoms targeted as requiring immediate intervention (ie, serious consideration of suicide) would result in the study nurse contacting the patient directly by phone and/or contacting clinicians to assure immediate intervention. However, it is important to note that this direct intervention by study staff was infrequent as most symptoms were addressed independently by the participant as desired. If a participant had not reported a period of planned hospitalization and did not respond for 3 consecutive days, study staff would contact the patient by phone to ascertain the reason for noncompliance.
Measures
The following indicators were selected as measures of acceptance (accrual rate), feasibility (utilization, nurse-initiated contacts), and/or satisfaction (satisfaction ratings). Narrative responses and a poststudy survey provided additional data examining acceptance, feasibility, and satisfaction with the intervention. In addition, demographic and medical information as well as measures assessing primary study outcomes were collected from each participant. Table 1 lists all measures and the study time point when they were administered.
| MEASURES | PRETREATMENT | DURING TREATMENT | POSTTREATMENT | CUMULATIVE |
|---|---|---|---|---|
| Demographics | X (baseline) | X | ||
| Accrual rate | X | |||
| Utilization rate | X | |||
| FACT-H&N | X (baseline) | X (mid-tx) | X (2–4 weeks post-tx) | |
| MSAS | X (baseline) | X (mid-tx) | X (2–4 weeks post-tx) | |
| Satisfaction with technology | X | |||
| Nurse-initiated contacts | X | |||
| Exit interview | X (end of treatment) | |||
| Poststudy written survey | X (60–90 days post-tx) |
tx = treatment
Accrual rate
The number of individuals assessed for study eligibility, reasons for exclusion or noncompletion, and numbers included in the analysis were all recorded to examine acceptance of the intervention and identify issues with the intervention or technology affecting participation.
Utilization
Feasibility was operationalized as device utilization using the percentage of days on which a participant responded to the Health Buddy. This was calculated using the number of days the participant responded to the telehealth device divided by the number of days the participant had the device and was expected to respond. These data were maintained and provided by the telehealth provider (Robert Bosch Healthcare).
Nurse-initiated contacts with participants and/or clinicians
The number of occasions on which a nurse decided to intervene was used as an indicator of feasibility under the premise that the goal of the intervention was to support and encourage patient-driven efforts to seek care for persistent or troubling symptoms. If a patient reported a symptom, he or she was given management information and encouraged to discuss problems further with the clinician either by phone or during clinic visits. If a patient continued to report an unresolved symptom or if the symptom required immediate intervention (ie, suicide threat), the research nurse reviewing responses would contact the patient and/or clinician to ascertain why and/or assist with its resolution. These nurse-initiated contacts should be infrequent if the intervention is achieving the goal of developing patient self-efficacy.
Satisfaction ratings
Items assessing satisfaction with the technology were also administered to participants via the telehealth messaging device. Questions related to satisfaction with the initial setup of the telehealth appliance were asked at the beginning of the intervention. Ongoing satisfaction with the device, messaging content, and the health-care provider were assessed every 90 days. The specific questions asked are detailed in Table 4.
Narrative data
Upon completion of the intervention, participants in the treatment group completed an exit interview using open-ended questions regarding the utility of the intervention, relevance of the algorithms, value or burden of item repetition in the algorithms, symptoms or problems experienced that were not addressed by the intervention, and general comments.
Poststudy survey
A final survey was mailed to participants several months after completion of the study, asking for additional feedback about the impact of the intervention. Specifically, participants (both treatment and control groups) were asked about their overall satisfaction with the treatment and services at the cancer center, their satisfaction with information received about their treatment, the response(s) received when they attempted contact with the health-care team after hours, the amount of support received, their current smoking and alcohol usage, and several demographic questions not earlier assessed or available through record review (years of education, highest degree, income range). Those receiving the intervention were also asked about the impact of the Health Buddy on their care and actions taken in response to the algorithms.
Demographic and medical information
Demographic information was collected using the initial survey, and information about the participant's medical history, condition, treatments received, treatment timing, complications, comorbidities, and treatment response was collected via retrospective medical record review subsequent to completion of the clinical trial.
Outcome measures
While outcomes of the clinical trial are not the subject of this article, the results of QOL and symptom burden measures for the treatment group only are included here because of their relationship with device utilization. The two measures included the Functional Assessment of Cancer Therapy–Head and Neck Scale and the Memorial Symptom Assessment Scale and were administered at baseline (before beginning treatment), mid-treatment, and posttreatment.
• Functional Assessment of Cancer Therapy–Head and Neck Scale (FACT-H&N). The FACT-G (general) is a multidimensional QOL instrument designed for use with all cancer patients. The instrument has 28 items divided into four subscales: Functional Well-Being, Physical Well-Being, Social Well-Being, and Emotional Well-Being. This generic core questionnaire was found to meet or exceed requirements for use in oncology based upon ease of administration, brevity, reliability, validity, and responsiveness to clinical change.30 Added to the core questionnaire is the head and neck–specific subscale, consisting of 11 items specific to this cancer site. A Trial Outcome Index (TOI) is also scored and is the result of the physical, functional, and cancer-specific subscales. List et al31 found the FACT-H&N to be reliable and sensitive to differences in functioning for patients with head and neck cancers (Cronbach's alpha was 0.89 for total FACT-G and 0.63 for the head and neck subscale in this study of 151 patients). Additionally, head and neck cancer patients found the FACT-H&N relevant to their problems and easy to understand, and it was preferred over other validated head and neck cancer QOL questionnaires.32 The FACT-H&N was chosen for this study because it (1) is nonspecific related to a treatment modality or subsite among head and neck cancers, (2) allows comparison across cancer diagnoses while still probing issues specific to head and neck cancer, (3) is short and can be completed quickly, (4) includes the psychosocial domains of social/family and emotion subscales as well as physical and functional areas, and (5) is self-administered.
• Memorial Symptom Assessment Scale (MSAS). This multidimensional scale measures the prevalence, severity, and distress associated with the most common symptoms experienced by cancer patients. Physical and emotional subscale scores as well as a Global Distress Index (GDI, considered to be a measure of total symptom burden) can be generated from patient responses. The MSAS has demonstrated validity and reliability in both in- and outpatient cancer populations.[33], [34] and [35] Initial psychometric analysis by Portenoy et al34 used factor analysis to define two subscales: psychological symptoms and physical symptoms with Cronbach alpha coefficients of 0.88 and 0.83, respectively; convergent validity was also established. It was chosen for this study because of its proven ability to measure both the presence and the intensity of experienced symptoms.[33], [35], [36], [37] and [38]
Data Analysis
Quantitative data were documented and analyzed using the Statistical Package for the Social Sciences (SPSS, Inc., Chicago, IL), version 16. Descriptive statistics were calculated to describe the sample and assess study outcomes, including feasibility and acceptability of the intervention. To ascertain relationships between usage of the device and demographic and medical information, a series of correlational analyses using Spearman's rho were conducted. This nonparametric test was chosen over Pearson's r because of the small sample size, the lack of a normal distribution for several of the variables, and the ordinal nature of several of the variables. Multiple regression analyses were also planned, but lack of significant bivariate correlations precluded multivariate analysis.
Qualitative responses to open-ended questions were analyzed to identify themes and direct quotations illustrating those themes.
Descriptive analysis of the treatment group's responses to the outcome measures (QOL and symptom burden) was done to ascertain changes over the course of the intervention using the mean scores at baseline, during treatment, and posttreatment.
Results
Description of Participants
Participants randomly assigned to the intervention group (n = 45) were an average age of 59 years (±11.7), and most were covered by private (34%) or public (48%) insurance. On average, participants had completed 13.5 years (±3.0) of formal education. Thirty-nine (87%) of the participants were male and 91% were Caucasian.
With regard to medical information, participants were predominantly diagnosed with stage II cancers of the head and neck (36%). The most prevalent site was the larynx (12 patients), followed by the tongue and the base of the tongue (seven patients) and unknown primary (seven patients). The vast majority received chemotherapy (32, or 71%) and/or radiation (42, or 93%).
Additional details regarding demographic and medical characteristics of the sample are provided in Table 2.
| FREQUENCY | VALID PERCENT | |
|---|---|---|
| Gender (n = 44) | ||
| Male | 39 | 88.6 |
| Female | 5 | 11.3 |
| Race (n = 44) | ||
| Caucasian | 40 | 90.9 |
| African American | 4 | 9.0 |
| Tumor stage (n = 44) | ||
| I | 7 | 15.9 |
| II | 15 | 34.0 |
| III | 11 | 25.0 |
| IV | 4 | 9.0 |
| Unable to determine | 5 | 11.4 |
| Unknown | 2 | 4.5 |
| Site of cancer (n = 44) | ||
| Larynx | 12 | 27.2 |
| Tongue, base of tongue | 7 | 15.9 |
| Unknown primary | 7 | 15.9 |
| Tonsillar | 4 | 9.0 |
| Other H&N sites | 14 | 31.8 |
| Insurance status (n = 44) | ||
| No insurance | 8 | 18.2 |
| Medicaid | 1 | 2.3 |
| Medicare | 2 | 4.5 |
| Medicaid and Medicare | 1 | 2.3 |
| Medicare and supplement | 9 | 20.5 |
| Medicare and VA benefits | 2 | 4.5 |
| Veteran benefits only | 6 | 13.6 |
| Private insurance | 15 | 34.1 |
| Highest educational degree (n = 20)a | ||
| Less than high school | 3 | 15.0 |
| High school or GED | 9 | 45.0 |
| Associate's/bachelor's degree | 4 | 20.0 |
| Masters, PhD, or MD | 2 | 10.0 |
| Other | 2 | 10.0 |
| Income range (n = 18)a | ||
| $20,000 or less | 5 | 27.8 |
| $20,001–50,000 | 5 | 27.8 |
| $70,001–100,000 | 5 | 27.8 |
| Over $100,000 | 3 | 16.7 |
| Percent of poverty in zip code area (n = 44) | ||
| 2.8–5.1% | 11 | 25.0 |
| 5.9–8.6% | 11 | 25.0 |
| 9.0–11.9% | 10 | 22.7 |
| 12.3–45.9% | 12 | 27.2 |
Feasibility and Acceptability
Accrual rate
Of the 185 patients assessed for eligibility during the 2-year recruitment period, 105 were excluded. See Figure 3 for a detailed depiction of study accrual for both the treatment and control groups. Thirty-three (31%) were excluded because they did not have a land phone line, a requirement for transmitting the algorithms to the Health Buddy appliance. Most of these had cell phones only. No potential participants refused participation due to issues related to operation of the technology itself.
Device utilization
Participants used the telehealth device for an average of 70.7 days (±26.7), which constituted 86.3% (±15.0) of the total days available for use. Of note, the median percentage of use was 94.2% and the modal percentage was 100%, indicating that the vast majority of participants consistently used the telehealth device. The participant with the lowest usage rate used the device 46% of the days available.
By far, the most common reason for Health Buddy nonresponse was patient hospitalization. Two subjects traveled out of town frequently on weekends and would leave the Health Buddy at home. One subject had accidentally unhooked the Health Buddy, and a home visit was made to reconnect the device into the patient's phone line.
Nurse-initiated contacts with participants and/or clinicians
Of the 45 enrolled patients, 33 required additional contact with a research nurse (see Table 3). The most common reasons patients were contacted were nonresponse for 3 consecutive days (38.3%), repeated reporting of high levels of unrelieved pain (30%), and suicidal thoughts (10%). In all, 120 calls were placed: one call for every 25.9 response days. In every case, the problem was resolved.
| NUMBER OF PATIENTS | PROBLEM | OUTGOING CALLS | RESOLUTION |
|---|---|---|---|
| 15 | No response on Health Buddy for 3 consecutive days | 46 | Patient teaching |
| 17 | Pain-related issues | 36 | Advocacy/referral/patient teaching |
| 5 | Suicidal thoughts | 12 | Advocacy/referral |
| 7 | G-tube problems | 8 | Patient teaching |
| 5 | Sadness/depression | 6 | Advocacy/referral |
| 3 | Multiple symptoms | 3 | Advocacy/referral |
| 3 | Nausea/vomiting | 4 | Referral/patient teaching |
| 2 | Coughing/excessive secretions | 2 | Patient teaching |
| 2 | Constipation | 2 | Patient teaching |
| 1 | Stomatitis | 1 | Referral |
Satisfaction ratings
Responses to surveys programmed into the Health Buddy system are displayed in Table 4. Overall, respondents responded favorably, finding the installation to be easy, the content to be helpful, and the overall experience to be positive.
| PERCENT OF RESPONDENTS | |
|---|---|
| Installation satisfaction | |
| Installation problems? | |
| Yes | 2 |
| No | 98 |
| Any difficulty completing the first training questions? | |
| Yes | 7 |
| No | 94 |
| Length of installation? | |
| 2–5 minutes | 52 |
| 6–10 minutes | 41 |
| 11–15 minutes | 4 |
| 16–20 minutes | 2 |
| Content satisfaction | |
| Overall, I think the Health Buddy questions are | |
| Very easy | 44 |
| Somewhat easy | 16 |
| Neutral | 32 |
| Somewhat difficult | 4 |
| Difficult | 4 |
| Repeating questions reinforced knowledge and understanding | |
| Strongly agree | 56 |
| Somewhat agree | 28 |
| Neutral | 12 |
| Somewhat disagree | 4 |
| Strongly disagree | 0 |
| Understanding of my health condition | |
| Much better | 64 |
| Somewhat better | 20 |
| Neutral | 16 |
| Somewhat worse | 0 |
| Much worse | 0 |
| Managing my health condition | |
| Much better | 52 |
| Somewhat better | 44 |
| Neutral | 4 |
| Somewhat worse | 0 |
| Much worse | 0 |
| Recommend the device to others | |
| Very willing | 80 |
| Somewhat willing | 12 |
| Neutral | 4 |
| Somewhat unwilling | 0 |
| Very unwilling | 4 |
| Overall satisfaction | |
| Satisfaction with device | |
| Very satisfied | 45 |
| Satisfied | 35 |
| Somewhat satisfied | 15 |
| Not very satisfied | 5 |
| Satisfaction with the communication between you and your doctor or nurse | |
| More satisfied | 65 |
| No difference | 30 |
| Less satisfied | 5 |
| Ease of using the device | |
| Very easy | 85 |
| Easy | 15 |
| Not easy | 0 |
| Overall experience with the device | |
| Positive | 85 |
| Neutral | 15 |
| Negative | 0 |
| Continue to use the device | |
| Very likely | 40 |
| Likely | 40 |
| Somewhat likely | 15 |
| Not very likely | 0 |
Narrative comments
During the exit interview, participants were asked, “How was having the Health Buddy helpful to you?” Responses could be categorized into two major themes: (1) the Health Buddy provided needed information and (2) the Health Buddy improved my self-management during treatment.
Statements made related to the information provided included the following:
- • It gave me information on what could be expected from treatment
• It was a constant reminder of things to watch for
• It kept me abreast of my total condition at all times
• It gave good directions so I didn't have to ask at the cancer center
• It gave good suggestions on treatments (home remedies) such as gargles, care of feeding tube, exhaustion, and everyday symptoms
Statements made indicative that the Health Buddy improved self-management included the following:
- • I learned what I could do to make myself feel better
• It helped me manage my symptoms
• It taught me about symptom management and how to handle problems
• It let me know whether to contact a doctor or use self-care
• It gave me who to call for problems and some things to try
• It kept me aware of what I needed to do in order to make the period easier
• It reminded me to take my meds and exercise
Additionally, some participants noted the support they felt from having the Health Buddy interventions during treatment in saying the following:
- • It kind of helped my depression through acknowledging it and giving me something to do
• It made me feel I was not the only one who had experience with these things
• It comforted me because I knew what was going to happen
Poststudy survey
Twenty (45%) of the 44 patients who received the intervention responded to the mailed poststudy survey. When asked if they felt they received better care because they had the device, 13 of the 20 (65%) responded that they did. Eighteen (90%) of the treatment group responders stated they were very satisfied with their care (one stated “somewhat satisfied”) and 20 (100%) said they would recommend the cancer center for treatment. Nineteen (95%) stated they received adequate support during treatment.
Outcome Measures
Mean scores on the FACT-H&N and subscales and the MSAS and subscales taken pre-, during, and posttreatment are displayed in Table 5. As expected, average QOL scores declined during treatment, while symptom distress increased, with a return to near baseline scores posttreatment.
| SCALE/SUBSCALE | PRETREATMENT | DURING TREATMENT | POSTTREATMENT |
|---|---|---|---|
| Total FACT-H&N | 100.3 | 85.6 | 101.5 |
| FACT-G | 74.3 | 69.4 | 78.5 |
| Trial Outcome Index | 62.6 | 46.0 | 65.0 |
| Physical Well-Being | 21.2 | 17.6 | 21.1 |
| Functional Well-Being | 15.6 | 12.5 | 17.4 |
| Emotional Well-Being | 21.1 | 22.3 | 22.2 |
| Social Well-Being | 21.1 | 22.3 | 22.2 |
| Total MSAS | 0.7 | 1.1 | 0.8 |
| Global Distress Index | 1.1 | 1.8 | 1.3 |
| Physical | 0.7 | 1.5 | 1.1 |
| Psychological | 1.1 | 1.2 | 0.8 |
Correlations
The relationships between percentage usage per patient and the following variables were evaluated: age, income, years of education, tumor stage, and percent poverty in patient's zip code. Percent poverty in zip code area was intended to be a surrogate measure of the patient's socioeconomic status. Results are displayed in Table 6. No significant correlations were noted, although years of education and percentage poverty in zip code showed a trend toward significance.
| VARIABLE (VS % USAGE) | RELATIONSHIP | |
|---|---|---|
| SPEARMAN'S RHO RS | SIGNIFICANCE (ONE-TAILED) | |
| Percent poverty in zip code | 0.213 | 0.083 |
| Age | 0.146 | 0.173 |
| Years of education | −0.325 | 0.081 |
| Income | −0.292 | 0.120 |
| Tumor stage | 0.196 | 0.122 |
| Physical Well-Being (during treatment) | 0.310 | 0.048 |
| Emotional Well-Being (during treatment) | 0.315 | 0.042 |
Although a multivariate model was planned, the lack of significant bivariate correlations precluded the need for multivariate analysis.
When percent usage was correlated with FACT-H&N total and subscales taken at baseline, during active treatment, and posttreatment, significant positive correlations were found between the percentage used and the Physical Well-Being subscale score during treatment (Spearman's rho = 0.310, P = 0.048) and between percentage used and the Emotional Well-Being subscale during treatment (Spearman's rho = 0.315, P = 0.042).
There were no significant correlations between percentage usage and the scores on the MSAS.
Discussion
Both qualitative and quantitative measures indicate that using telehealth to support symptom management during aggressive cancer treatment is both feasible and well-accepted. Patient users were not intimidated by this particular technology as it was simple to set up and use and required no previous computer training to operate. The Health Buddy was viewed as providing important and useful information. Overall, users felt that it improved their ability to self-manage their disease and the side effects of treatment and provided a sense of support and security.
Unlike other studies which use telehealth devices to monitor patient symptoms, our goal was to increase patient self-management of the symptoms experienced during intensive medical treatment, therefore avoiding increased burden on the medical system. The fact that the research nurse overseeing the responses needed to intervene only once every 25.9 days speaks to the ability of the intervention to have a positive impact on utilization of medical services.
The lack of significant relationships between usage and descriptive variables such as age and years of education suggests that the intervention was equally acceptable to all subgroups. Factors such as age, previous computer literacy, educational obtainment, and socioeconomic status did not significantly differentiate our study population in terms of compliance as verified by usage percentages.
The significant relationships found between the percentage used and the subscale scores on Physical Well-Being and Emotional Well-Being during treatment may indicate that increased use of the telemessaging intervention during treatment resulted in better physical and emotional aspects of QOL.
The high rate of daily compliance with the intervention in spite of differentiating personal variables and the severity of the treatment regimen may have been due to one or a combination of the following factors:
- • the simplicity of the technology
• the visibility of the appliance (often placed in the kitchen or living area of the home) and its flashing green light as cues to the need to respond
• the usefulness of the information provided
• the use of simple messaging language presented in an encouraging, positive manner
• affirmations related to application of the symptom management protocols suggested
• curiosity related to the day's messaging and the motivational saying which always appeared at the end
• knowledge that someone was reviewing the responses, tracking and intervening when the participant did not respond for several days
Our study supports the benefits of telehealth interventions noted by providers in a study by Sandberg et al39: opportunities for more frequent contact, greater relaxation and information due to the ability to interact in one's own home, increased accessibility by those frequently underserved, and timely medical information and monitoring. Similar to the study done in the Netherlands,[27] and [28] this study noted technological problems as the primary disadvantage; but in our intervention, we had no problems with the technology or equipment.
Although computerized technology served as a barrier to previous telehealth research, the lack of a land-based phone line was a factor preventing participation in the current study. Indeed, many participants maintained only wireless communication devices, which were not compatible with the version of the Health Buddy that was employed in this study. However, improvements in the technology since completion of this study now allow for wireless access to the appliance or provision of an independent wireless messaging device for those without such access in their own homes.
Although the data generally support the feasibility and acceptability of the telehealth-based intervention, the results should be interpreted in the context of a few study limitations. In particular, the sample size was somewhat small, and data pertaining to the socioeconomic status of participants were not available for all participants. Second, the study did not include measures of the patient's direct interactions with health-care providers during the study or specific data related to their health-care utilization (eg, emergency room visits, preventable inpatient hospitalizations, emergency calls to clinicians). The collection of more exhaustive measures of health-care utilization was limited by resources but is planned for subsequent studies. Finally, concerns regarding subject burden limited assessment of the usability of the telehealth device.
Although compliance with utilization expectations and completion of study measures was excellent during the course of the intervention, response to the follow-up survey mailed several months later was less than 50%. This low response rate was most likely due to several factors: (1) this survey was sent at the conclusion of the entire study (by this time, patients were 0–21 months past their active participation); (2) it was a mailed survey with no additional contact or follow-up effort to increase response rate; (3) participants may have felt that they had already shared their opinions in the exit interview and may have felt overburdened by study measures at this point; and (4) participants may have died, moved, or been medically unable to respond. This lack of response did limit our ability to evaluate the longitudinal impact of the intervention.
Conclusions
This telehealth intervention proved to be an acceptable and feasible means to educate and support patients during aggressive treatment for head and neck cancer. Patient compliance with telehealth interventions during periods of extreme symptom burden and declining QOL is feasible if simple technology cues the patient to participate, offers positive support and relevant education, and is targeted or tailored to their specific condition.
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16 R. de Bree et al., Touch screen computer-assisted health-related quality of life and distress data collection in head and neck cancer patients, Clin Otolaryngol 33 (2) (2008), pp. 138–142. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (6)
17 H. Huang et al., Developing a computerized data collection and decision support system for cancer pain management, Comput Inform Nurs 21 (4) (2003), pp. 206–217. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (17)
18 D.J. Wilkie et al., Usability of a computerized pain report in the general public with pain and people with cancer pain, J Pain Symptom Manage 25 (3) (2003), pp. 213–224. Article |
19 K. Kroenke et al., Effect of telecare management on pain and depression in patients with cancer: a randomized trial, JAMA 304 (2) (2010), pp. 163–171. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (7)
20 N. Kearney et al., Utilizing handheld computers to monitor and support patients receiving chemotherapy: results of a UK-based feasibility study, Support Care Cancer 14 (7) (2006), pp. 742–752. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (17)
21 N.R. Chumbler et al., Remote patient–provider communication and quality of life: empirical test of a dialogic model of cancer care, J Telemed Telecare 13 (2007), pp. 20–25. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (5)
22 A.L. Grubaugh et al., Attitudes toward medical and mental health care delivered via telehealth applications among rural and urban primary care patients, J Nerv Ment Dis 196 (2) (2008), pp. 166–170. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (6)
23 J. Stalfors et al., Accuracy of tele-oncology compared with face-to-face consultation in head and neck cancer case conferences, J Telemed Telecare 7 (2001), pp. 338–343. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (5)
24 C. Dorrian et al., Head and neck cancer assessment by flexible endoscopy and telemedicine, J Telemed Telecare 15 (2009), pp. 118–121. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (3)
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26 C. Myers, Telehealth applications in head and neck oncology, J Speech Lang Pathol Audiol 29 (3) (2005), pp. 125–127.
27 J.L. van den Brink et al., Involving the patient: a prospective study on use, appreciation and effectiveness of an information system in head and neck cancer care, Int J Med Inform 74 (10) (2005), pp. 839–849. Article |
28 J.L. van den Brink et al., Impact on quality of life of a telemedicine system supporting head and neck cancer patients: a controlled trial during the postoperative period at home, J Am Med Inform Assoc 14 (2) (2007), pp. 198–205. Article |
29 B. Head et al., Development of a telehhealth intervention for head and neck cancer patients, Telemed J E Health 15 (1) (2009), pp. 100–108. View Record in Scopus | Cited By in Scopus (1)
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31 M.A. List et al., The Performance Status scale for head and neck cancer patients and the Functional Assessment of Cancer Therapy-Head and Neck scale: A study of utility and validity, Cancer 77 (11) (1996), pp. 2294–2301. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (169)
32 H.M. Mehanna and R.P. Morton, Patients' views on the utility of quality of life questionnaires in head and neck cancer: a randomised trial, Clin Otolaryngol 31 (4) (2006), pp. 310–316. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (10)
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34 R.K. Portenoy et al., The Memorial Symptom Assessment Scale: an instrument for the evaluation of symptom prevalence, characteristics and distress, Eur J Cancer 30A (9) (1994), pp. 1326–1336. Abstract |
35 J.E. Tranmer et al., Measuring the symptom experience of seriously ill cancer and noncancer hospitalized patients near the end of life with the Memorial Symptom Assessment Scale, J Pain Symptom Manage 25 (5) (2003), pp. 420–429. Article |
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Treatment for head and neck cancer is most often a rigorous regimen of combination therapies, producing a multitude of distressing symptoms and side effects. While it is nearly impossible to circumvent the physical and psychosocial insults caused by such treatment, some interventions directed toward educating and supporting patients during active treatment have met with success.[1], [2], [3] and [4] Conversely, other efforts have demonstrated little impact[5] and [6] or have been poorly received,7 pointing to the need for effective, acceptable means to provide support during such difficult treatment.
Over the past 10 years, telemedicine technology has enabled innovative approaches for improving patient education, assessment, support, and communication during treatment for both acute and chronic diseases. A recent policy white paper8 described telemedicine technology as including “the electronic acquisition, processing, dissemination, storage, retrieval, and exchange of information for the purpose of promoting health, preventing disease, treating the sick, managing chronic illness, rehabilitating the disabled, and protecting public health and safety” (p. 2). This same paper suggests that national telemedicine initiatives are essential to health-care reform based upon their proven cost–effectiveness and clinical efficacy. However, cost savings and clinical effectiveness will be unrealized outcomes if the interventions are not feasible in practice or acceptable to the targeted population.
In the arena of cancer care, telephone-based systems have been used to report and monitor cancer symptoms with favorable compliance noted even when patients are expected to initiate calls on a regular basis.[9], [10], [11] and [12] Favorable acceptance ratings have also been reported by both patients and clinicians regarding computerized systems used to assess symptoms and quality of life (QOL) in cancer patients.[13], [14], [15], [16], [17], [18] and [19] In the United Kingdom, a handheld computer system was successfully used to monitor and support patients receiving chemotherapy for lung or colorectal cancer,20 and a study testing a dialogic model of cancer care expecting patients to respond to telehealth messaging on a daily basis over 6 months reported an 84% cooperation rate.21 In these studies, the majority of patients reported ease of use and acceptability of the technology. Survey research has found both urban and rural cancer patients to be receptive to medical and psychiatric services provided via telehealth.22
Published reports describing use of telehealth and computerized interventions during head and neck cancer treatment are less prevalent. Touch-screen computers were successfully used in the Netherlands to collect QOL and distress data from head and neck cancer patients.16 Videoconferencing has been used successfully to overcome geographical barriers to patient assessment[23], [24] and [25] and to provide speech–language pathology services to people living with head and neck cancers in remote areas. Reported use of telehealth management appears promising for providing timely access to care for those who are geographically isolated.26
A research group based in the Netherlands developed and tested a comprehensive electronic health information support system for use in head and neck cancer care.27 The system had four patient-related functions: facilitating communication between patients and health-care providers, providing information about the disease and its treatment, connecting patients with other patients similarly diagnosed, and monitoring patients after hospital discharge. The system was found to be well-accepted and appreciated by participating patients, and its use enabled early identification and direct intervention for patient problems.27 A clinical trial of the telehealth application showed improved QOL in five of 22 studied parameters for the treatment group.28 However, 20 of the 59 patients eligible for the intervention group refused participation; 11 (55%) of these stated computer-related concerns as their reason for nonparticipation.
Knowing that head and neck cancer patients experience a high burden of illness and often have significant communication, socioeconomic, and geographic barriers to care, our team developed a telehealth intervention using a simple telemessaging device to circumvent communication barriers and perceived technical challenges associated with computer-based systems to provide education and support to patients in their own home and on their own time schedule.29 Overall, we hypothesized that patients receiving the intervention would experience less symptom distress, improved QOL, increased self-efficacy, and greater satisfaction with symptom management than those in the control group. However, as a first step toward examining the efficacy and effectiveness of this intervention, this study examined both quantitative and qualitative indicators of its feasibility and acceptance among patients undergoing treatment for head and neck cancer.
Methods
Design
Subsequent to study approval by the University of Louisville's Human Subjects Protection Office, a randomized clinical trial comparing the telehealth intervention to standard care was conducted using a two-group parallel design. This study reports on the intervention's feasibility and acceptance in the treatment group of 44 patients.
Site
Participants were recruited from patients receiving care from the Multidisciplinary Head and Neck Cancer Team at the James Graham Brown Cancer Center (JGBCC) over a 2-year period (June 2006 through June 2008). The team consisted of head and neck surgeons, medical oncologists, radiation oncologists, nurses, a pathologist, a speech therapist, a registered dietician, a psychologist, and a social worker. This team developed a comprehensive assessment and treatment plan during each patient's initial visit to the clinic and coordinated patient care throughout the treatment process.
Sample
Patients eligible for study participation met the following inclusion criteria: (1) initial diagnosis of head or neck cancer including cancers of the oral cavity, salivary glands, paranasal sinuses and nasal cavity, pharynx, and larynx; (2) involvement in a treatment plan including one or more modalities (ie, surgery, chemotherapy, radiation, or any combination); (3) capacity to give independent informed consent; and (4) ability to speak, read, and comprehend English at the eighth-grade level or above. Patients were excluded from participation if they had no land telephone line, had a thought disorder, were incarcerated, or had compromised cognitive functioning.
All patients scheduled for assessment received an explanation of the research study via print materials prior to their first clinic visit. During their first scheduled clinic visit, all patients identified as eligible were approached by a member of the research study staff, who briefly explained the study and asked if they might be interested in study participation. Because of the stress and content of this first clinic visit, interested patients were contacted later by phone to schedule an additional visit to review the study and obtain informed consent.
During the informed consent meeting, the study procedures were explained in detail. If the patient agreed and signed a consent form, a randomization grid which considered the patient's particular treatment plan was used to assign the patient to either the control or the experimental group. Baseline data were also collected during this first visit.
Description of the Intervention
The technology selected for implementing the intervention was the Health Buddy® System, a commercially available, proprietary system produced and maintained by Robert Bosch Healthcare Palo Alto, CA. The Health Buddy, the appliance used for interaction between the participant and the health-care provider, is a user-friendly, easily visible, electrical device that attaches to the user's land phone line (see Figure 1). Questions and information are displayed on the liquid crystal display (LCD) screen of the 6 × 9–inch appliance. The individual responds to questions by pressing one of the four large buttons below the screen. The research team selected the technology provider based on the ability of the technology to perform in accordance with the research objectives.
Symptom control algorithms developed using participatory action research (surveys of current and past patients and clinicians) and evidence-based practice were programmed into the telehealth messaging system (see article by Head et al,29 which details the algorithm topic selection and development process). The algorithms addressed 29 different symptoms and side effects of treatment, consisting of approximately 100 questions accompanied by related educational and supportive responses. Patients were asked three to five questions daily related to the symptoms anticipated during their treatment scenario. Depending upon their response, they would receive specific information related to symptom self-management, including recommendations as to when to contact their clinicians. The algorithms were constructed with the goal of encouraging self-efficacy and independent action on the part of the participant. See Figure 2 for an example of the branching algorithms.
Participants randomly assigned to the treatment group immediately had the Health Buddy connected to a land telephone line in their home. Most (40%) chose to place it in their kitchen, while another 26% placed it in their bedrooms; most often, it was in a highly visible location, serving to remind the participant to respond. Research study staff delivered, installed, and demonstrated how to operate the equipment. Installation was simple and required only minutes. A tutorial programmed into the Health Buddy taught participants how to reply to questions appearing on the monitor using the four large keys below the possible answers or a rating scale which would appear depending on the type of question asked.
During the early hours of the morning, the device would automatically call a toll-free number. Responses to the previous day's questions were uploaded, and questions and related information for the next day were downloaded over the telephone line onto a secure server. Phone service was never disrupted by the device; if the phone was in use, the system would connect later to retrieve and download information. Once new content was transferred, a green light on the device would flash to alert the participant that new questions were available for response. Once the participant pressed any of the keys, the new algorithms would begin appearing on the monitor screen.
Participants were instructed to begin responding on the first day they received treatment or on the first day after returning home from surgery. They were asked to continue responding daily (unless hospitalized for treatment) throughout the treatment period and for approximately 2 weeks posttreatment as treatment-induced symptoms continue during that period of time. Study staff contacted participants when treatment was complete and scheduled a date to pick up the appliance and end daily responding. Daily patient responses required 5–10 minutes.
Participant responses could be viewed by study staff via Internet access 1 day after being answered. Responses were monitored daily by study nurses. Symptoms unrelieved over time or symptoms targeted as requiring immediate intervention (ie, serious consideration of suicide) would result in the study nurse contacting the patient directly by phone and/or contacting clinicians to assure immediate intervention. However, it is important to note that this direct intervention by study staff was infrequent as most symptoms were addressed independently by the participant as desired. If a participant had not reported a period of planned hospitalization and did not respond for 3 consecutive days, study staff would contact the patient by phone to ascertain the reason for noncompliance.
Measures
The following indicators were selected as measures of acceptance (accrual rate), feasibility (utilization, nurse-initiated contacts), and/or satisfaction (satisfaction ratings). Narrative responses and a poststudy survey provided additional data examining acceptance, feasibility, and satisfaction with the intervention. In addition, demographic and medical information as well as measures assessing primary study outcomes were collected from each participant. Table 1 lists all measures and the study time point when they were administered.
| MEASURES | PRETREATMENT | DURING TREATMENT | POSTTREATMENT | CUMULATIVE |
|---|---|---|---|---|
| Demographics | X (baseline) | X | ||
| Accrual rate | X | |||
| Utilization rate | X | |||
| FACT-H&N | X (baseline) | X (mid-tx) | X (2–4 weeks post-tx) | |
| MSAS | X (baseline) | X (mid-tx) | X (2–4 weeks post-tx) | |
| Satisfaction with technology | X | |||
| Nurse-initiated contacts | X | |||
| Exit interview | X (end of treatment) | |||
| Poststudy written survey | X (60–90 days post-tx) |
tx = treatment
Accrual rate
The number of individuals assessed for study eligibility, reasons for exclusion or noncompletion, and numbers included in the analysis were all recorded to examine acceptance of the intervention and identify issues with the intervention or technology affecting participation.
Utilization
Feasibility was operationalized as device utilization using the percentage of days on which a participant responded to the Health Buddy. This was calculated using the number of days the participant responded to the telehealth device divided by the number of days the participant had the device and was expected to respond. These data were maintained and provided by the telehealth provider (Robert Bosch Healthcare).
Nurse-initiated contacts with participants and/or clinicians
The number of occasions on which a nurse decided to intervene was used as an indicator of feasibility under the premise that the goal of the intervention was to support and encourage patient-driven efforts to seek care for persistent or troubling symptoms. If a patient reported a symptom, he or she was given management information and encouraged to discuss problems further with the clinician either by phone or during clinic visits. If a patient continued to report an unresolved symptom or if the symptom required immediate intervention (ie, suicide threat), the research nurse reviewing responses would contact the patient and/or clinician to ascertain why and/or assist with its resolution. These nurse-initiated contacts should be infrequent if the intervention is achieving the goal of developing patient self-efficacy.
Satisfaction ratings
Items assessing satisfaction with the technology were also administered to participants via the telehealth messaging device. Questions related to satisfaction with the initial setup of the telehealth appliance were asked at the beginning of the intervention. Ongoing satisfaction with the device, messaging content, and the health-care provider were assessed every 90 days. The specific questions asked are detailed in Table 4.
Narrative data
Upon completion of the intervention, participants in the treatment group completed an exit interview using open-ended questions regarding the utility of the intervention, relevance of the algorithms, value or burden of item repetition in the algorithms, symptoms or problems experienced that were not addressed by the intervention, and general comments.
Poststudy survey
A final survey was mailed to participants several months after completion of the study, asking for additional feedback about the impact of the intervention. Specifically, participants (both treatment and control groups) were asked about their overall satisfaction with the treatment and services at the cancer center, their satisfaction with information received about their treatment, the response(s) received when they attempted contact with the health-care team after hours, the amount of support received, their current smoking and alcohol usage, and several demographic questions not earlier assessed or available through record review (years of education, highest degree, income range). Those receiving the intervention were also asked about the impact of the Health Buddy on their care and actions taken in response to the algorithms.
Demographic and medical information
Demographic information was collected using the initial survey, and information about the participant's medical history, condition, treatments received, treatment timing, complications, comorbidities, and treatment response was collected via retrospective medical record review subsequent to completion of the clinical trial.
Outcome measures
While outcomes of the clinical trial are not the subject of this article, the results of QOL and symptom burden measures for the treatment group only are included here because of their relationship with device utilization. The two measures included the Functional Assessment of Cancer Therapy–Head and Neck Scale and the Memorial Symptom Assessment Scale and were administered at baseline (before beginning treatment), mid-treatment, and posttreatment.
• Functional Assessment of Cancer Therapy–Head and Neck Scale (FACT-H&N). The FACT-G (general) is a multidimensional QOL instrument designed for use with all cancer patients. The instrument has 28 items divided into four subscales: Functional Well-Being, Physical Well-Being, Social Well-Being, and Emotional Well-Being. This generic core questionnaire was found to meet or exceed requirements for use in oncology based upon ease of administration, brevity, reliability, validity, and responsiveness to clinical change.30 Added to the core questionnaire is the head and neck–specific subscale, consisting of 11 items specific to this cancer site. A Trial Outcome Index (TOI) is also scored and is the result of the physical, functional, and cancer-specific subscales. List et al31 found the FACT-H&N to be reliable and sensitive to differences in functioning for patients with head and neck cancers (Cronbach's alpha was 0.89 for total FACT-G and 0.63 for the head and neck subscale in this study of 151 patients). Additionally, head and neck cancer patients found the FACT-H&N relevant to their problems and easy to understand, and it was preferred over other validated head and neck cancer QOL questionnaires.32 The FACT-H&N was chosen for this study because it (1) is nonspecific related to a treatment modality or subsite among head and neck cancers, (2) allows comparison across cancer diagnoses while still probing issues specific to head and neck cancer, (3) is short and can be completed quickly, (4) includes the psychosocial domains of social/family and emotion subscales as well as physical and functional areas, and (5) is self-administered.
• Memorial Symptom Assessment Scale (MSAS). This multidimensional scale measures the prevalence, severity, and distress associated with the most common symptoms experienced by cancer patients. Physical and emotional subscale scores as well as a Global Distress Index (GDI, considered to be a measure of total symptom burden) can be generated from patient responses. The MSAS has demonstrated validity and reliability in both in- and outpatient cancer populations.[33], [34] and [35] Initial psychometric analysis by Portenoy et al34 used factor analysis to define two subscales: psychological symptoms and physical symptoms with Cronbach alpha coefficients of 0.88 and 0.83, respectively; convergent validity was also established. It was chosen for this study because of its proven ability to measure both the presence and the intensity of experienced symptoms.[33], [35], [36], [37] and [38]
Data Analysis
Quantitative data were documented and analyzed using the Statistical Package for the Social Sciences (SPSS, Inc., Chicago, IL), version 16. Descriptive statistics were calculated to describe the sample and assess study outcomes, including feasibility and acceptability of the intervention. To ascertain relationships between usage of the device and demographic and medical information, a series of correlational analyses using Spearman's rho were conducted. This nonparametric test was chosen over Pearson's r because of the small sample size, the lack of a normal distribution for several of the variables, and the ordinal nature of several of the variables. Multiple regression analyses were also planned, but lack of significant bivariate correlations precluded multivariate analysis.
Qualitative responses to open-ended questions were analyzed to identify themes and direct quotations illustrating those themes.
Descriptive analysis of the treatment group's responses to the outcome measures (QOL and symptom burden) was done to ascertain changes over the course of the intervention using the mean scores at baseline, during treatment, and posttreatment.
Results
Description of Participants
Participants randomly assigned to the intervention group (n = 45) were an average age of 59 years (±11.7), and most were covered by private (34%) or public (48%) insurance. On average, participants had completed 13.5 years (±3.0) of formal education. Thirty-nine (87%) of the participants were male and 91% were Caucasian.
With regard to medical information, participants were predominantly diagnosed with stage II cancers of the head and neck (36%). The most prevalent site was the larynx (12 patients), followed by the tongue and the base of the tongue (seven patients) and unknown primary (seven patients). The vast majority received chemotherapy (32, or 71%) and/or radiation (42, or 93%).
Additional details regarding demographic and medical characteristics of the sample are provided in Table 2.
| FREQUENCY | VALID PERCENT | |
|---|---|---|
| Gender (n = 44) | ||
| Male | 39 | 88.6 |
| Female | 5 | 11.3 |
| Race (n = 44) | ||
| Caucasian | 40 | 90.9 |
| African American | 4 | 9.0 |
| Tumor stage (n = 44) | ||
| I | 7 | 15.9 |
| II | 15 | 34.0 |
| III | 11 | 25.0 |
| IV | 4 | 9.0 |
| Unable to determine | 5 | 11.4 |
| Unknown | 2 | 4.5 |
| Site of cancer (n = 44) | ||
| Larynx | 12 | 27.2 |
| Tongue, base of tongue | 7 | 15.9 |
| Unknown primary | 7 | 15.9 |
| Tonsillar | 4 | 9.0 |
| Other H&N sites | 14 | 31.8 |
| Insurance status (n = 44) | ||
| No insurance | 8 | 18.2 |
| Medicaid | 1 | 2.3 |
| Medicare | 2 | 4.5 |
| Medicaid and Medicare | 1 | 2.3 |
| Medicare and supplement | 9 | 20.5 |
| Medicare and VA benefits | 2 | 4.5 |
| Veteran benefits only | 6 | 13.6 |
| Private insurance | 15 | 34.1 |
| Highest educational degree (n = 20)a | ||
| Less than high school | 3 | 15.0 |
| High school or GED | 9 | 45.0 |
| Associate's/bachelor's degree | 4 | 20.0 |
| Masters, PhD, or MD | 2 | 10.0 |
| Other | 2 | 10.0 |
| Income range (n = 18)a | ||
| $20,000 or less | 5 | 27.8 |
| $20,001–50,000 | 5 | 27.8 |
| $70,001–100,000 | 5 | 27.8 |
| Over $100,000 | 3 | 16.7 |
| Percent of poverty in zip code area (n = 44) | ||
| 2.8–5.1% | 11 | 25.0 |
| 5.9–8.6% | 11 | 25.0 |
| 9.0–11.9% | 10 | 22.7 |
| 12.3–45.9% | 12 | 27.2 |
Feasibility and Acceptability
Accrual rate
Of the 185 patients assessed for eligibility during the 2-year recruitment period, 105 were excluded. See Figure 3 for a detailed depiction of study accrual for both the treatment and control groups. Thirty-three (31%) were excluded because they did not have a land phone line, a requirement for transmitting the algorithms to the Health Buddy appliance. Most of these had cell phones only. No potential participants refused participation due to issues related to operation of the technology itself.
Device utilization
Participants used the telehealth device for an average of 70.7 days (±26.7), which constituted 86.3% (±15.0) of the total days available for use. Of note, the median percentage of use was 94.2% and the modal percentage was 100%, indicating that the vast majority of participants consistently used the telehealth device. The participant with the lowest usage rate used the device 46% of the days available.
By far, the most common reason for Health Buddy nonresponse was patient hospitalization. Two subjects traveled out of town frequently on weekends and would leave the Health Buddy at home. One subject had accidentally unhooked the Health Buddy, and a home visit was made to reconnect the device into the patient's phone line.
Nurse-initiated contacts with participants and/or clinicians
Of the 45 enrolled patients, 33 required additional contact with a research nurse (see Table 3). The most common reasons patients were contacted were nonresponse for 3 consecutive days (38.3%), repeated reporting of high levels of unrelieved pain (30%), and suicidal thoughts (10%). In all, 120 calls were placed: one call for every 25.9 response days. In every case, the problem was resolved.
| NUMBER OF PATIENTS | PROBLEM | OUTGOING CALLS | RESOLUTION |
|---|---|---|---|
| 15 | No response on Health Buddy for 3 consecutive days | 46 | Patient teaching |
| 17 | Pain-related issues | 36 | Advocacy/referral/patient teaching |
| 5 | Suicidal thoughts | 12 | Advocacy/referral |
| 7 | G-tube problems | 8 | Patient teaching |
| 5 | Sadness/depression | 6 | Advocacy/referral |
| 3 | Multiple symptoms | 3 | Advocacy/referral |
| 3 | Nausea/vomiting | 4 | Referral/patient teaching |
| 2 | Coughing/excessive secretions | 2 | Patient teaching |
| 2 | Constipation | 2 | Patient teaching |
| 1 | Stomatitis | 1 | Referral |
Satisfaction ratings
Responses to surveys programmed into the Health Buddy system are displayed in Table 4. Overall, respondents responded favorably, finding the installation to be easy, the content to be helpful, and the overall experience to be positive.
| PERCENT OF RESPONDENTS | |
|---|---|
| Installation satisfaction | |
| Installation problems? | |
| Yes | 2 |
| No | 98 |
| Any difficulty completing the first training questions? | |
| Yes | 7 |
| No | 94 |
| Length of installation? | |
| 2–5 minutes | 52 |
| 6–10 minutes | 41 |
| 11–15 minutes | 4 |
| 16–20 minutes | 2 |
| Content satisfaction | |
| Overall, I think the Health Buddy questions are | |
| Very easy | 44 |
| Somewhat easy | 16 |
| Neutral | 32 |
| Somewhat difficult | 4 |
| Difficult | 4 |
| Repeating questions reinforced knowledge and understanding | |
| Strongly agree | 56 |
| Somewhat agree | 28 |
| Neutral | 12 |
| Somewhat disagree | 4 |
| Strongly disagree | 0 |
| Understanding of my health condition | |
| Much better | 64 |
| Somewhat better | 20 |
| Neutral | 16 |
| Somewhat worse | 0 |
| Much worse | 0 |
| Managing my health condition | |
| Much better | 52 |
| Somewhat better | 44 |
| Neutral | 4 |
| Somewhat worse | 0 |
| Much worse | 0 |
| Recommend the device to others | |
| Very willing | 80 |
| Somewhat willing | 12 |
| Neutral | 4 |
| Somewhat unwilling | 0 |
| Very unwilling | 4 |
| Overall satisfaction | |
| Satisfaction with device | |
| Very satisfied | 45 |
| Satisfied | 35 |
| Somewhat satisfied | 15 |
| Not very satisfied | 5 |
| Satisfaction with the communication between you and your doctor or nurse | |
| More satisfied | 65 |
| No difference | 30 |
| Less satisfied | 5 |
| Ease of using the device | |
| Very easy | 85 |
| Easy | 15 |
| Not easy | 0 |
| Overall experience with the device | |
| Positive | 85 |
| Neutral | 15 |
| Negative | 0 |
| Continue to use the device | |
| Very likely | 40 |
| Likely | 40 |
| Somewhat likely | 15 |
| Not very likely | 0 |
Narrative comments
During the exit interview, participants were asked, “How was having the Health Buddy helpful to you?” Responses could be categorized into two major themes: (1) the Health Buddy provided needed information and (2) the Health Buddy improved my self-management during treatment.
Statements made related to the information provided included the following:
- • It gave me information on what could be expected from treatment
• It was a constant reminder of things to watch for
• It kept me abreast of my total condition at all times
• It gave good directions so I didn't have to ask at the cancer center
• It gave good suggestions on treatments (home remedies) such as gargles, care of feeding tube, exhaustion, and everyday symptoms
Statements made indicative that the Health Buddy improved self-management included the following:
- • I learned what I could do to make myself feel better
• It helped me manage my symptoms
• It taught me about symptom management and how to handle problems
• It let me know whether to contact a doctor or use self-care
• It gave me who to call for problems and some things to try
• It kept me aware of what I needed to do in order to make the period easier
• It reminded me to take my meds and exercise
Additionally, some participants noted the support they felt from having the Health Buddy interventions during treatment in saying the following:
- • It kind of helped my depression through acknowledging it and giving me something to do
• It made me feel I was not the only one who had experience with these things
• It comforted me because I knew what was going to happen
Poststudy survey
Twenty (45%) of the 44 patients who received the intervention responded to the mailed poststudy survey. When asked if they felt they received better care because they had the device, 13 of the 20 (65%) responded that they did. Eighteen (90%) of the treatment group responders stated they were very satisfied with their care (one stated “somewhat satisfied”) and 20 (100%) said they would recommend the cancer center for treatment. Nineteen (95%) stated they received adequate support during treatment.
Outcome Measures
Mean scores on the FACT-H&N and subscales and the MSAS and subscales taken pre-, during, and posttreatment are displayed in Table 5. As expected, average QOL scores declined during treatment, while symptom distress increased, with a return to near baseline scores posttreatment.
| SCALE/SUBSCALE | PRETREATMENT | DURING TREATMENT | POSTTREATMENT |
|---|---|---|---|
| Total FACT-H&N | 100.3 | 85.6 | 101.5 |
| FACT-G | 74.3 | 69.4 | 78.5 |
| Trial Outcome Index | 62.6 | 46.0 | 65.0 |
| Physical Well-Being | 21.2 | 17.6 | 21.1 |
| Functional Well-Being | 15.6 | 12.5 | 17.4 |
| Emotional Well-Being | 21.1 | 22.3 | 22.2 |
| Social Well-Being | 21.1 | 22.3 | 22.2 |
| Total MSAS | 0.7 | 1.1 | 0.8 |
| Global Distress Index | 1.1 | 1.8 | 1.3 |
| Physical | 0.7 | 1.5 | 1.1 |
| Psychological | 1.1 | 1.2 | 0.8 |
Correlations
The relationships between percentage usage per patient and the following variables were evaluated: age, income, years of education, tumor stage, and percent poverty in patient's zip code. Percent poverty in zip code area was intended to be a surrogate measure of the patient's socioeconomic status. Results are displayed in Table 6. No significant correlations were noted, although years of education and percentage poverty in zip code showed a trend toward significance.
| VARIABLE (VS % USAGE) | RELATIONSHIP | |
|---|---|---|
| SPEARMAN'S RHO RS | SIGNIFICANCE (ONE-TAILED) | |
| Percent poverty in zip code | 0.213 | 0.083 |
| Age | 0.146 | 0.173 |
| Years of education | −0.325 | 0.081 |
| Income | −0.292 | 0.120 |
| Tumor stage | 0.196 | 0.122 |
| Physical Well-Being (during treatment) | 0.310 | 0.048 |
| Emotional Well-Being (during treatment) | 0.315 | 0.042 |
Although a multivariate model was planned, the lack of significant bivariate correlations precluded the need for multivariate analysis.
When percent usage was correlated with FACT-H&N total and subscales taken at baseline, during active treatment, and posttreatment, significant positive correlations were found between the percentage used and the Physical Well-Being subscale score during treatment (Spearman's rho = 0.310, P = 0.048) and between percentage used and the Emotional Well-Being subscale during treatment (Spearman's rho = 0.315, P = 0.042).
There were no significant correlations between percentage usage and the scores on the MSAS.
Discussion
Both qualitative and quantitative measures indicate that using telehealth to support symptom management during aggressive cancer treatment is both feasible and well-accepted. Patient users were not intimidated by this particular technology as it was simple to set up and use and required no previous computer training to operate. The Health Buddy was viewed as providing important and useful information. Overall, users felt that it improved their ability to self-manage their disease and the side effects of treatment and provided a sense of support and security.
Unlike other studies which use telehealth devices to monitor patient symptoms, our goal was to increase patient self-management of the symptoms experienced during intensive medical treatment, therefore avoiding increased burden on the medical system. The fact that the research nurse overseeing the responses needed to intervene only once every 25.9 days speaks to the ability of the intervention to have a positive impact on utilization of medical services.
The lack of significant relationships between usage and descriptive variables such as age and years of education suggests that the intervention was equally acceptable to all subgroups. Factors such as age, previous computer literacy, educational obtainment, and socioeconomic status did not significantly differentiate our study population in terms of compliance as verified by usage percentages.
The significant relationships found between the percentage used and the subscale scores on Physical Well-Being and Emotional Well-Being during treatment may indicate that increased use of the telemessaging intervention during treatment resulted in better physical and emotional aspects of QOL.
The high rate of daily compliance with the intervention in spite of differentiating personal variables and the severity of the treatment regimen may have been due to one or a combination of the following factors:
- • the simplicity of the technology
• the visibility of the appliance (often placed in the kitchen or living area of the home) and its flashing green light as cues to the need to respond
• the usefulness of the information provided
• the use of simple messaging language presented in an encouraging, positive manner
• affirmations related to application of the symptom management protocols suggested
• curiosity related to the day's messaging and the motivational saying which always appeared at the end
• knowledge that someone was reviewing the responses, tracking and intervening when the participant did not respond for several days
Our study supports the benefits of telehealth interventions noted by providers in a study by Sandberg et al39: opportunities for more frequent contact, greater relaxation and information due to the ability to interact in one's own home, increased accessibility by those frequently underserved, and timely medical information and monitoring. Similar to the study done in the Netherlands,[27] and [28] this study noted technological problems as the primary disadvantage; but in our intervention, we had no problems with the technology or equipment.
Although computerized technology served as a barrier to previous telehealth research, the lack of a land-based phone line was a factor preventing participation in the current study. Indeed, many participants maintained only wireless communication devices, which were not compatible with the version of the Health Buddy that was employed in this study. However, improvements in the technology since completion of this study now allow for wireless access to the appliance or provision of an independent wireless messaging device for those without such access in their own homes.
Although the data generally support the feasibility and acceptability of the telehealth-based intervention, the results should be interpreted in the context of a few study limitations. In particular, the sample size was somewhat small, and data pertaining to the socioeconomic status of participants were not available for all participants. Second, the study did not include measures of the patient's direct interactions with health-care providers during the study or specific data related to their health-care utilization (eg, emergency room visits, preventable inpatient hospitalizations, emergency calls to clinicians). The collection of more exhaustive measures of health-care utilization was limited by resources but is planned for subsequent studies. Finally, concerns regarding subject burden limited assessment of the usability of the telehealth device.
Although compliance with utilization expectations and completion of study measures was excellent during the course of the intervention, response to the follow-up survey mailed several months later was less than 50%. This low response rate was most likely due to several factors: (1) this survey was sent at the conclusion of the entire study (by this time, patients were 0–21 months past their active participation); (2) it was a mailed survey with no additional contact or follow-up effort to increase response rate; (3) participants may have felt that they had already shared their opinions in the exit interview and may have felt overburdened by study measures at this point; and (4) participants may have died, moved, or been medically unable to respond. This lack of response did limit our ability to evaluate the longitudinal impact of the intervention.
Conclusions
This telehealth intervention proved to be an acceptable and feasible means to educate and support patients during aggressive treatment for head and neck cancer. Patient compliance with telehealth interventions during periods of extreme symptom burden and declining QOL is feasible if simple technology cues the patient to participate, offers positive support and relevant education, and is targeted or tailored to their specific condition.
Treatment for head and neck cancer is most often a rigorous regimen of combination therapies, producing a multitude of distressing symptoms and side effects. While it is nearly impossible to circumvent the physical and psychosocial insults caused by such treatment, some interventions directed toward educating and supporting patients during active treatment have met with success.[1], [2], [3] and [4] Conversely, other efforts have demonstrated little impact[5] and [6] or have been poorly received,7 pointing to the need for effective, acceptable means to provide support during such difficult treatment.
Over the past 10 years, telemedicine technology has enabled innovative approaches for improving patient education, assessment, support, and communication during treatment for both acute and chronic diseases. A recent policy white paper8 described telemedicine technology as including “the electronic acquisition, processing, dissemination, storage, retrieval, and exchange of information for the purpose of promoting health, preventing disease, treating the sick, managing chronic illness, rehabilitating the disabled, and protecting public health and safety” (p. 2). This same paper suggests that national telemedicine initiatives are essential to health-care reform based upon their proven cost–effectiveness and clinical efficacy. However, cost savings and clinical effectiveness will be unrealized outcomes if the interventions are not feasible in practice or acceptable to the targeted population.
In the arena of cancer care, telephone-based systems have been used to report and monitor cancer symptoms with favorable compliance noted even when patients are expected to initiate calls on a regular basis.[9], [10], [11] and [12] Favorable acceptance ratings have also been reported by both patients and clinicians regarding computerized systems used to assess symptoms and quality of life (QOL) in cancer patients.[13], [14], [15], [16], [17], [18] and [19] In the United Kingdom, a handheld computer system was successfully used to monitor and support patients receiving chemotherapy for lung or colorectal cancer,20 and a study testing a dialogic model of cancer care expecting patients to respond to telehealth messaging on a daily basis over 6 months reported an 84% cooperation rate.21 In these studies, the majority of patients reported ease of use and acceptability of the technology. Survey research has found both urban and rural cancer patients to be receptive to medical and psychiatric services provided via telehealth.22
Published reports describing use of telehealth and computerized interventions during head and neck cancer treatment are less prevalent. Touch-screen computers were successfully used in the Netherlands to collect QOL and distress data from head and neck cancer patients.16 Videoconferencing has been used successfully to overcome geographical barriers to patient assessment[23], [24] and [25] and to provide speech–language pathology services to people living with head and neck cancers in remote areas. Reported use of telehealth management appears promising for providing timely access to care for those who are geographically isolated.26
A research group based in the Netherlands developed and tested a comprehensive electronic health information support system for use in head and neck cancer care.27 The system had four patient-related functions: facilitating communication between patients and health-care providers, providing information about the disease and its treatment, connecting patients with other patients similarly diagnosed, and monitoring patients after hospital discharge. The system was found to be well-accepted and appreciated by participating patients, and its use enabled early identification and direct intervention for patient problems.27 A clinical trial of the telehealth application showed improved QOL in five of 22 studied parameters for the treatment group.28 However, 20 of the 59 patients eligible for the intervention group refused participation; 11 (55%) of these stated computer-related concerns as their reason for nonparticipation.
Knowing that head and neck cancer patients experience a high burden of illness and often have significant communication, socioeconomic, and geographic barriers to care, our team developed a telehealth intervention using a simple telemessaging device to circumvent communication barriers and perceived technical challenges associated with computer-based systems to provide education and support to patients in their own home and on their own time schedule.29 Overall, we hypothesized that patients receiving the intervention would experience less symptom distress, improved QOL, increased self-efficacy, and greater satisfaction with symptom management than those in the control group. However, as a first step toward examining the efficacy and effectiveness of this intervention, this study examined both quantitative and qualitative indicators of its feasibility and acceptance among patients undergoing treatment for head and neck cancer.
Methods
Design
Subsequent to study approval by the University of Louisville's Human Subjects Protection Office, a randomized clinical trial comparing the telehealth intervention to standard care was conducted using a two-group parallel design. This study reports on the intervention's feasibility and acceptance in the treatment group of 44 patients.
Site
Participants were recruited from patients receiving care from the Multidisciplinary Head and Neck Cancer Team at the James Graham Brown Cancer Center (JGBCC) over a 2-year period (June 2006 through June 2008). The team consisted of head and neck surgeons, medical oncologists, radiation oncologists, nurses, a pathologist, a speech therapist, a registered dietician, a psychologist, and a social worker. This team developed a comprehensive assessment and treatment plan during each patient's initial visit to the clinic and coordinated patient care throughout the treatment process.
Sample
Patients eligible for study participation met the following inclusion criteria: (1) initial diagnosis of head or neck cancer including cancers of the oral cavity, salivary glands, paranasal sinuses and nasal cavity, pharynx, and larynx; (2) involvement in a treatment plan including one or more modalities (ie, surgery, chemotherapy, radiation, or any combination); (3) capacity to give independent informed consent; and (4) ability to speak, read, and comprehend English at the eighth-grade level or above. Patients were excluded from participation if they had no land telephone line, had a thought disorder, were incarcerated, or had compromised cognitive functioning.
All patients scheduled for assessment received an explanation of the research study via print materials prior to their first clinic visit. During their first scheduled clinic visit, all patients identified as eligible were approached by a member of the research study staff, who briefly explained the study and asked if they might be interested in study participation. Because of the stress and content of this first clinic visit, interested patients were contacted later by phone to schedule an additional visit to review the study and obtain informed consent.
During the informed consent meeting, the study procedures were explained in detail. If the patient agreed and signed a consent form, a randomization grid which considered the patient's particular treatment plan was used to assign the patient to either the control or the experimental group. Baseline data were also collected during this first visit.
Description of the Intervention
The technology selected for implementing the intervention was the Health Buddy® System, a commercially available, proprietary system produced and maintained by Robert Bosch Healthcare Palo Alto, CA. The Health Buddy, the appliance used for interaction between the participant and the health-care provider, is a user-friendly, easily visible, electrical device that attaches to the user's land phone line (see Figure 1). Questions and information are displayed on the liquid crystal display (LCD) screen of the 6 × 9–inch appliance. The individual responds to questions by pressing one of the four large buttons below the screen. The research team selected the technology provider based on the ability of the technology to perform in accordance with the research objectives.
Symptom control algorithms developed using participatory action research (surveys of current and past patients and clinicians) and evidence-based practice were programmed into the telehealth messaging system (see article by Head et al,29 which details the algorithm topic selection and development process). The algorithms addressed 29 different symptoms and side effects of treatment, consisting of approximately 100 questions accompanied by related educational and supportive responses. Patients were asked three to five questions daily related to the symptoms anticipated during their treatment scenario. Depending upon their response, they would receive specific information related to symptom self-management, including recommendations as to when to contact their clinicians. The algorithms were constructed with the goal of encouraging self-efficacy and independent action on the part of the participant. See Figure 2 for an example of the branching algorithms.
Participants randomly assigned to the treatment group immediately had the Health Buddy connected to a land telephone line in their home. Most (40%) chose to place it in their kitchen, while another 26% placed it in their bedrooms; most often, it was in a highly visible location, serving to remind the participant to respond. Research study staff delivered, installed, and demonstrated how to operate the equipment. Installation was simple and required only minutes. A tutorial programmed into the Health Buddy taught participants how to reply to questions appearing on the monitor using the four large keys below the possible answers or a rating scale which would appear depending on the type of question asked.
During the early hours of the morning, the device would automatically call a toll-free number. Responses to the previous day's questions were uploaded, and questions and related information for the next day were downloaded over the telephone line onto a secure server. Phone service was never disrupted by the device; if the phone was in use, the system would connect later to retrieve and download information. Once new content was transferred, a green light on the device would flash to alert the participant that new questions were available for response. Once the participant pressed any of the keys, the new algorithms would begin appearing on the monitor screen.
Participants were instructed to begin responding on the first day they received treatment or on the first day after returning home from surgery. They were asked to continue responding daily (unless hospitalized for treatment) throughout the treatment period and for approximately 2 weeks posttreatment as treatment-induced symptoms continue during that period of time. Study staff contacted participants when treatment was complete and scheduled a date to pick up the appliance and end daily responding. Daily patient responses required 5–10 minutes.
Participant responses could be viewed by study staff via Internet access 1 day after being answered. Responses were monitored daily by study nurses. Symptoms unrelieved over time or symptoms targeted as requiring immediate intervention (ie, serious consideration of suicide) would result in the study nurse contacting the patient directly by phone and/or contacting clinicians to assure immediate intervention. However, it is important to note that this direct intervention by study staff was infrequent as most symptoms were addressed independently by the participant as desired. If a participant had not reported a period of planned hospitalization and did not respond for 3 consecutive days, study staff would contact the patient by phone to ascertain the reason for noncompliance.
Measures
The following indicators were selected as measures of acceptance (accrual rate), feasibility (utilization, nurse-initiated contacts), and/or satisfaction (satisfaction ratings). Narrative responses and a poststudy survey provided additional data examining acceptance, feasibility, and satisfaction with the intervention. In addition, demographic and medical information as well as measures assessing primary study outcomes were collected from each participant. Table 1 lists all measures and the study time point when they were administered.
| MEASURES | PRETREATMENT | DURING TREATMENT | POSTTREATMENT | CUMULATIVE |
|---|---|---|---|---|
| Demographics | X (baseline) | X | ||
| Accrual rate | X | |||
| Utilization rate | X | |||
| FACT-H&N | X (baseline) | X (mid-tx) | X (2–4 weeks post-tx) | |
| MSAS | X (baseline) | X (mid-tx) | X (2–4 weeks post-tx) | |
| Satisfaction with technology | X | |||
| Nurse-initiated contacts | X | |||
| Exit interview | X (end of treatment) | |||
| Poststudy written survey | X (60–90 days post-tx) |
tx = treatment
Accrual rate
The number of individuals assessed for study eligibility, reasons for exclusion or noncompletion, and numbers included in the analysis were all recorded to examine acceptance of the intervention and identify issues with the intervention or technology affecting participation.
Utilization
Feasibility was operationalized as device utilization using the percentage of days on which a participant responded to the Health Buddy. This was calculated using the number of days the participant responded to the telehealth device divided by the number of days the participant had the device and was expected to respond. These data were maintained and provided by the telehealth provider (Robert Bosch Healthcare).
Nurse-initiated contacts with participants and/or clinicians
The number of occasions on which a nurse decided to intervene was used as an indicator of feasibility under the premise that the goal of the intervention was to support and encourage patient-driven efforts to seek care for persistent or troubling symptoms. If a patient reported a symptom, he or she was given management information and encouraged to discuss problems further with the clinician either by phone or during clinic visits. If a patient continued to report an unresolved symptom or if the symptom required immediate intervention (ie, suicide threat), the research nurse reviewing responses would contact the patient and/or clinician to ascertain why and/or assist with its resolution. These nurse-initiated contacts should be infrequent if the intervention is achieving the goal of developing patient self-efficacy.
Satisfaction ratings
Items assessing satisfaction with the technology were also administered to participants via the telehealth messaging device. Questions related to satisfaction with the initial setup of the telehealth appliance were asked at the beginning of the intervention. Ongoing satisfaction with the device, messaging content, and the health-care provider were assessed every 90 days. The specific questions asked are detailed in Table 4.
Narrative data
Upon completion of the intervention, participants in the treatment group completed an exit interview using open-ended questions regarding the utility of the intervention, relevance of the algorithms, value or burden of item repetition in the algorithms, symptoms or problems experienced that were not addressed by the intervention, and general comments.
Poststudy survey
A final survey was mailed to participants several months after completion of the study, asking for additional feedback about the impact of the intervention. Specifically, participants (both treatment and control groups) were asked about their overall satisfaction with the treatment and services at the cancer center, their satisfaction with information received about their treatment, the response(s) received when they attempted contact with the health-care team after hours, the amount of support received, their current smoking and alcohol usage, and several demographic questions not earlier assessed or available through record review (years of education, highest degree, income range). Those receiving the intervention were also asked about the impact of the Health Buddy on their care and actions taken in response to the algorithms.
Demographic and medical information
Demographic information was collected using the initial survey, and information about the participant's medical history, condition, treatments received, treatment timing, complications, comorbidities, and treatment response was collected via retrospective medical record review subsequent to completion of the clinical trial.
Outcome measures
While outcomes of the clinical trial are not the subject of this article, the results of QOL and symptom burden measures for the treatment group only are included here because of their relationship with device utilization. The two measures included the Functional Assessment of Cancer Therapy–Head and Neck Scale and the Memorial Symptom Assessment Scale and were administered at baseline (before beginning treatment), mid-treatment, and posttreatment.
• Functional Assessment of Cancer Therapy–Head and Neck Scale (FACT-H&N). The FACT-G (general) is a multidimensional QOL instrument designed for use with all cancer patients. The instrument has 28 items divided into four subscales: Functional Well-Being, Physical Well-Being, Social Well-Being, and Emotional Well-Being. This generic core questionnaire was found to meet or exceed requirements for use in oncology based upon ease of administration, brevity, reliability, validity, and responsiveness to clinical change.30 Added to the core questionnaire is the head and neck–specific subscale, consisting of 11 items specific to this cancer site. A Trial Outcome Index (TOI) is also scored and is the result of the physical, functional, and cancer-specific subscales. List et al31 found the FACT-H&N to be reliable and sensitive to differences in functioning for patients with head and neck cancers (Cronbach's alpha was 0.89 for total FACT-G and 0.63 for the head and neck subscale in this study of 151 patients). Additionally, head and neck cancer patients found the FACT-H&N relevant to their problems and easy to understand, and it was preferred over other validated head and neck cancer QOL questionnaires.32 The FACT-H&N was chosen for this study because it (1) is nonspecific related to a treatment modality or subsite among head and neck cancers, (2) allows comparison across cancer diagnoses while still probing issues specific to head and neck cancer, (3) is short and can be completed quickly, (4) includes the psychosocial domains of social/family and emotion subscales as well as physical and functional areas, and (5) is self-administered.
• Memorial Symptom Assessment Scale (MSAS). This multidimensional scale measures the prevalence, severity, and distress associated with the most common symptoms experienced by cancer patients. Physical and emotional subscale scores as well as a Global Distress Index (GDI, considered to be a measure of total symptom burden) can be generated from patient responses. The MSAS has demonstrated validity and reliability in both in- and outpatient cancer populations.[33], [34] and [35] Initial psychometric analysis by Portenoy et al34 used factor analysis to define two subscales: psychological symptoms and physical symptoms with Cronbach alpha coefficients of 0.88 and 0.83, respectively; convergent validity was also established. It was chosen for this study because of its proven ability to measure both the presence and the intensity of experienced symptoms.[33], [35], [36], [37] and [38]
Data Analysis
Quantitative data were documented and analyzed using the Statistical Package for the Social Sciences (SPSS, Inc., Chicago, IL), version 16. Descriptive statistics were calculated to describe the sample and assess study outcomes, including feasibility and acceptability of the intervention. To ascertain relationships between usage of the device and demographic and medical information, a series of correlational analyses using Spearman's rho were conducted. This nonparametric test was chosen over Pearson's r because of the small sample size, the lack of a normal distribution for several of the variables, and the ordinal nature of several of the variables. Multiple regression analyses were also planned, but lack of significant bivariate correlations precluded multivariate analysis.
Qualitative responses to open-ended questions were analyzed to identify themes and direct quotations illustrating those themes.
Descriptive analysis of the treatment group's responses to the outcome measures (QOL and symptom burden) was done to ascertain changes over the course of the intervention using the mean scores at baseline, during treatment, and posttreatment.
Results
Description of Participants
Participants randomly assigned to the intervention group (n = 45) were an average age of 59 years (±11.7), and most were covered by private (34%) or public (48%) insurance. On average, participants had completed 13.5 years (±3.0) of formal education. Thirty-nine (87%) of the participants were male and 91% were Caucasian.
With regard to medical information, participants were predominantly diagnosed with stage II cancers of the head and neck (36%). The most prevalent site was the larynx (12 patients), followed by the tongue and the base of the tongue (seven patients) and unknown primary (seven patients). The vast majority received chemotherapy (32, or 71%) and/or radiation (42, or 93%).
Additional details regarding demographic and medical characteristics of the sample are provided in Table 2.
| FREQUENCY | VALID PERCENT | |
|---|---|---|
| Gender (n = 44) | ||
| Male | 39 | 88.6 |
| Female | 5 | 11.3 |
| Race (n = 44) | ||
| Caucasian | 40 | 90.9 |
| African American | 4 | 9.0 |
| Tumor stage (n = 44) | ||
| I | 7 | 15.9 |
| II | 15 | 34.0 |
| III | 11 | 25.0 |
| IV | 4 | 9.0 |
| Unable to determine | 5 | 11.4 |
| Unknown | 2 | 4.5 |
| Site of cancer (n = 44) | ||
| Larynx | 12 | 27.2 |
| Tongue, base of tongue | 7 | 15.9 |
| Unknown primary | 7 | 15.9 |
| Tonsillar | 4 | 9.0 |
| Other H&N sites | 14 | 31.8 |
| Insurance status (n = 44) | ||
| No insurance | 8 | 18.2 |
| Medicaid | 1 | 2.3 |
| Medicare | 2 | 4.5 |
| Medicaid and Medicare | 1 | 2.3 |
| Medicare and supplement | 9 | 20.5 |
| Medicare and VA benefits | 2 | 4.5 |
| Veteran benefits only | 6 | 13.6 |
| Private insurance | 15 | 34.1 |
| Highest educational degree (n = 20)a | ||
| Less than high school | 3 | 15.0 |
| High school or GED | 9 | 45.0 |
| Associate's/bachelor's degree | 4 | 20.0 |
| Masters, PhD, or MD | 2 | 10.0 |
| Other | 2 | 10.0 |
| Income range (n = 18)a | ||
| $20,000 or less | 5 | 27.8 |
| $20,001–50,000 | 5 | 27.8 |
| $70,001–100,000 | 5 | 27.8 |
| Over $100,000 | 3 | 16.7 |
| Percent of poverty in zip code area (n = 44) | ||
| 2.8–5.1% | 11 | 25.0 |
| 5.9–8.6% | 11 | 25.0 |
| 9.0–11.9% | 10 | 22.7 |
| 12.3–45.9% | 12 | 27.2 |
Feasibility and Acceptability
Accrual rate
Of the 185 patients assessed for eligibility during the 2-year recruitment period, 105 were excluded. See Figure 3 for a detailed depiction of study accrual for both the treatment and control groups. Thirty-three (31%) were excluded because they did not have a land phone line, a requirement for transmitting the algorithms to the Health Buddy appliance. Most of these had cell phones only. No potential participants refused participation due to issues related to operation of the technology itself.
Device utilization
Participants used the telehealth device for an average of 70.7 days (±26.7), which constituted 86.3% (±15.0) of the total days available for use. Of note, the median percentage of use was 94.2% and the modal percentage was 100%, indicating that the vast majority of participants consistently used the telehealth device. The participant with the lowest usage rate used the device 46% of the days available.
By far, the most common reason for Health Buddy nonresponse was patient hospitalization. Two subjects traveled out of town frequently on weekends and would leave the Health Buddy at home. One subject had accidentally unhooked the Health Buddy, and a home visit was made to reconnect the device into the patient's phone line.
Nurse-initiated contacts with participants and/or clinicians
Of the 45 enrolled patients, 33 required additional contact with a research nurse (see Table 3). The most common reasons patients were contacted were nonresponse for 3 consecutive days (38.3%), repeated reporting of high levels of unrelieved pain (30%), and suicidal thoughts (10%). In all, 120 calls were placed: one call for every 25.9 response days. In every case, the problem was resolved.
| NUMBER OF PATIENTS | PROBLEM | OUTGOING CALLS | RESOLUTION |
|---|---|---|---|
| 15 | No response on Health Buddy for 3 consecutive days | 46 | Patient teaching |
| 17 | Pain-related issues | 36 | Advocacy/referral/patient teaching |
| 5 | Suicidal thoughts | 12 | Advocacy/referral |
| 7 | G-tube problems | 8 | Patient teaching |
| 5 | Sadness/depression | 6 | Advocacy/referral |
| 3 | Multiple symptoms | 3 | Advocacy/referral |
| 3 | Nausea/vomiting | 4 | Referral/patient teaching |
| 2 | Coughing/excessive secretions | 2 | Patient teaching |
| 2 | Constipation | 2 | Patient teaching |
| 1 | Stomatitis | 1 | Referral |
Satisfaction ratings
Responses to surveys programmed into the Health Buddy system are displayed in Table 4. Overall, respondents responded favorably, finding the installation to be easy, the content to be helpful, and the overall experience to be positive.
| PERCENT OF RESPONDENTS | |
|---|---|
| Installation satisfaction | |
| Installation problems? | |
| Yes | 2 |
| No | 98 |
| Any difficulty completing the first training questions? | |
| Yes | 7 |
| No | 94 |
| Length of installation? | |
| 2–5 minutes | 52 |
| 6–10 minutes | 41 |
| 11–15 minutes | 4 |
| 16–20 minutes | 2 |
| Content satisfaction | |
| Overall, I think the Health Buddy questions are | |
| Very easy | 44 |
| Somewhat easy | 16 |
| Neutral | 32 |
| Somewhat difficult | 4 |
| Difficult | 4 |
| Repeating questions reinforced knowledge and understanding | |
| Strongly agree | 56 |
| Somewhat agree | 28 |
| Neutral | 12 |
| Somewhat disagree | 4 |
| Strongly disagree | 0 |
| Understanding of my health condition | |
| Much better | 64 |
| Somewhat better | 20 |
| Neutral | 16 |
| Somewhat worse | 0 |
| Much worse | 0 |
| Managing my health condition | |
| Much better | 52 |
| Somewhat better | 44 |
| Neutral | 4 |
| Somewhat worse | 0 |
| Much worse | 0 |
| Recommend the device to others | |
| Very willing | 80 |
| Somewhat willing | 12 |
| Neutral | 4 |
| Somewhat unwilling | 0 |
| Very unwilling | 4 |
| Overall satisfaction | |
| Satisfaction with device | |
| Very satisfied | 45 |
| Satisfied | 35 |
| Somewhat satisfied | 15 |
| Not very satisfied | 5 |
| Satisfaction with the communication between you and your doctor or nurse | |
| More satisfied | 65 |
| No difference | 30 |
| Less satisfied | 5 |
| Ease of using the device | |
| Very easy | 85 |
| Easy | 15 |
| Not easy | 0 |
| Overall experience with the device | |
| Positive | 85 |
| Neutral | 15 |
| Negative | 0 |
| Continue to use the device | |
| Very likely | 40 |
| Likely | 40 |
| Somewhat likely | 15 |
| Not very likely | 0 |
Narrative comments
During the exit interview, participants were asked, “How was having the Health Buddy helpful to you?” Responses could be categorized into two major themes: (1) the Health Buddy provided needed information and (2) the Health Buddy improved my self-management during treatment.
Statements made related to the information provided included the following:
- • It gave me information on what could be expected from treatment
• It was a constant reminder of things to watch for
• It kept me abreast of my total condition at all times
• It gave good directions so I didn't have to ask at the cancer center
• It gave good suggestions on treatments (home remedies) such as gargles, care of feeding tube, exhaustion, and everyday symptoms
Statements made indicative that the Health Buddy improved self-management included the following:
- • I learned what I could do to make myself feel better
• It helped me manage my symptoms
• It taught me about symptom management and how to handle problems
• It let me know whether to contact a doctor or use self-care
• It gave me who to call for problems and some things to try
• It kept me aware of what I needed to do in order to make the period easier
• It reminded me to take my meds and exercise
Additionally, some participants noted the support they felt from having the Health Buddy interventions during treatment in saying the following:
- • It kind of helped my depression through acknowledging it and giving me something to do
• It made me feel I was not the only one who had experience with these things
• It comforted me because I knew what was going to happen
Poststudy survey
Twenty (45%) of the 44 patients who received the intervention responded to the mailed poststudy survey. When asked if they felt they received better care because they had the device, 13 of the 20 (65%) responded that they did. Eighteen (90%) of the treatment group responders stated they were very satisfied with their care (one stated “somewhat satisfied”) and 20 (100%) said they would recommend the cancer center for treatment. Nineteen (95%) stated they received adequate support during treatment.
Outcome Measures
Mean scores on the FACT-H&N and subscales and the MSAS and subscales taken pre-, during, and posttreatment are displayed in Table 5. As expected, average QOL scores declined during treatment, while symptom distress increased, with a return to near baseline scores posttreatment.
| SCALE/SUBSCALE | PRETREATMENT | DURING TREATMENT | POSTTREATMENT |
|---|---|---|---|
| Total FACT-H&N | 100.3 | 85.6 | 101.5 |
| FACT-G | 74.3 | 69.4 | 78.5 |
| Trial Outcome Index | 62.6 | 46.0 | 65.0 |
| Physical Well-Being | 21.2 | 17.6 | 21.1 |
| Functional Well-Being | 15.6 | 12.5 | 17.4 |
| Emotional Well-Being | 21.1 | 22.3 | 22.2 |
| Social Well-Being | 21.1 | 22.3 | 22.2 |
| Total MSAS | 0.7 | 1.1 | 0.8 |
| Global Distress Index | 1.1 | 1.8 | 1.3 |
| Physical | 0.7 | 1.5 | 1.1 |
| Psychological | 1.1 | 1.2 | 0.8 |
Correlations
The relationships between percentage usage per patient and the following variables were evaluated: age, income, years of education, tumor stage, and percent poverty in patient's zip code. Percent poverty in zip code area was intended to be a surrogate measure of the patient's socioeconomic status. Results are displayed in Table 6. No significant correlations were noted, although years of education and percentage poverty in zip code showed a trend toward significance.
| VARIABLE (VS % USAGE) | RELATIONSHIP | |
|---|---|---|
| SPEARMAN'S RHO RS | SIGNIFICANCE (ONE-TAILED) | |
| Percent poverty in zip code | 0.213 | 0.083 |
| Age | 0.146 | 0.173 |
| Years of education | −0.325 | 0.081 |
| Income | −0.292 | 0.120 |
| Tumor stage | 0.196 | 0.122 |
| Physical Well-Being (during treatment) | 0.310 | 0.048 |
| Emotional Well-Being (during treatment) | 0.315 | 0.042 |
Although a multivariate model was planned, the lack of significant bivariate correlations precluded the need for multivariate analysis.
When percent usage was correlated with FACT-H&N total and subscales taken at baseline, during active treatment, and posttreatment, significant positive correlations were found between the percentage used and the Physical Well-Being subscale score during treatment (Spearman's rho = 0.310, P = 0.048) and between percentage used and the Emotional Well-Being subscale during treatment (Spearman's rho = 0.315, P = 0.042).
There were no significant correlations between percentage usage and the scores on the MSAS.
Discussion
Both qualitative and quantitative measures indicate that using telehealth to support symptom management during aggressive cancer treatment is both feasible and well-accepted. Patient users were not intimidated by this particular technology as it was simple to set up and use and required no previous computer training to operate. The Health Buddy was viewed as providing important and useful information. Overall, users felt that it improved their ability to self-manage their disease and the side effects of treatment and provided a sense of support and security.
Unlike other studies which use telehealth devices to monitor patient symptoms, our goal was to increase patient self-management of the symptoms experienced during intensive medical treatment, therefore avoiding increased burden on the medical system. The fact that the research nurse overseeing the responses needed to intervene only once every 25.9 days speaks to the ability of the intervention to have a positive impact on utilization of medical services.
The lack of significant relationships between usage and descriptive variables such as age and years of education suggests that the intervention was equally acceptable to all subgroups. Factors such as age, previous computer literacy, educational obtainment, and socioeconomic status did not significantly differentiate our study population in terms of compliance as verified by usage percentages.
The significant relationships found between the percentage used and the subscale scores on Physical Well-Being and Emotional Well-Being during treatment may indicate that increased use of the telemessaging intervention during treatment resulted in better physical and emotional aspects of QOL.
The high rate of daily compliance with the intervention in spite of differentiating personal variables and the severity of the treatment regimen may have been due to one or a combination of the following factors:
- • the simplicity of the technology
• the visibility of the appliance (often placed in the kitchen or living area of the home) and its flashing green light as cues to the need to respond
• the usefulness of the information provided
• the use of simple messaging language presented in an encouraging, positive manner
• affirmations related to application of the symptom management protocols suggested
• curiosity related to the day's messaging and the motivational saying which always appeared at the end
• knowledge that someone was reviewing the responses, tracking and intervening when the participant did not respond for several days
Our study supports the benefits of telehealth interventions noted by providers in a study by Sandberg et al39: opportunities for more frequent contact, greater relaxation and information due to the ability to interact in one's own home, increased accessibility by those frequently underserved, and timely medical information and monitoring. Similar to the study done in the Netherlands,[27] and [28] this study noted technological problems as the primary disadvantage; but in our intervention, we had no problems with the technology or equipment.
Although computerized technology served as a barrier to previous telehealth research, the lack of a land-based phone line was a factor preventing participation in the current study. Indeed, many participants maintained only wireless communication devices, which were not compatible with the version of the Health Buddy that was employed in this study. However, improvements in the technology since completion of this study now allow for wireless access to the appliance or provision of an independent wireless messaging device for those without such access in their own homes.
Although the data generally support the feasibility and acceptability of the telehealth-based intervention, the results should be interpreted in the context of a few study limitations. In particular, the sample size was somewhat small, and data pertaining to the socioeconomic status of participants were not available for all participants. Second, the study did not include measures of the patient's direct interactions with health-care providers during the study or specific data related to their health-care utilization (eg, emergency room visits, preventable inpatient hospitalizations, emergency calls to clinicians). The collection of more exhaustive measures of health-care utilization was limited by resources but is planned for subsequent studies. Finally, concerns regarding subject burden limited assessment of the usability of the telehealth device.
Although compliance with utilization expectations and completion of study measures was excellent during the course of the intervention, response to the follow-up survey mailed several months later was less than 50%. This low response rate was most likely due to several factors: (1) this survey was sent at the conclusion of the entire study (by this time, patients were 0–21 months past their active participation); (2) it was a mailed survey with no additional contact or follow-up effort to increase response rate; (3) participants may have felt that they had already shared their opinions in the exit interview and may have felt overburdened by study measures at this point; and (4) participants may have died, moved, or been medically unable to respond. This lack of response did limit our ability to evaluate the longitudinal impact of the intervention.
Conclusions
This telehealth intervention proved to be an acceptable and feasible means to educate and support patients during aggressive treatment for head and neck cancer. Patient compliance with telehealth interventions during periods of extreme symptom burden and declining QOL is feasible if simple technology cues the patient to participate, offers positive support and relevant education, and is targeted or tailored to their specific condition.
1 C.D. Llewellyn, M. McGurk and J. Weinman, Are psycho-social and behavioural factors related to health related-quality of life in patients with head and neck cancer?: A systematic review, Oral Oncol 41 (5) (2005), pp. 440–454. Article |
2 K.T. Vakharia, M.J. Ali and S.J. Wang, Quality-of-life impact of participation in a head and neck cancer support group, Otolaryngol Head Neck Surg 136 (3) (2007), pp. 405–410. Article |
3 P.J. Allison et al., Results of a feasibility study for a psycho-educational intervention in head and neck cancer, Psychooncology 13 (2004), pp. 482–485. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (22)
4 L.H. Karnell et al., Influence of social support on health-related quality of life outcomes in head and neck cancer, Head Neck 29 (2) (2007), pp. 143–146. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (19)
5 K.M. Petruson, E.M. Silander and E.B. Hammerlid, Effects of psychosocial intervention on quality of life in patients with head and neck cancer, Head Neck 25 (7) (2003), pp. 576–584. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (29)
6 J.R.J. deLeeuw et al., Negative and positive influences of social support on depression in patients with head and neck cancer: a prospective study, Psychooncology 9 (2000), pp. 20–28. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (46)
7 J. Ostroff et al., Interest in and barriers to participation in multiple family groups among head and neck cancer survivors and their primary family caregivers, Fam Process 43 (2) (2004), pp. 195–208. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (17)
8 R.L. Bashshur et al., National telemedicine initiatives: essential to healthcare reform, Telemed J E Health 15 (6) (2009), pp. 1–11.
9 K. Davis et al., An innovative symptom monitoring tool for people with advanced lung cancer: a pilot demonstration, J Support Oncol 5 (8) (2007), pp. 381–387. View Record in Scopus | Cited By in Scopus (8)
10 K.H. Mooney et al., Telephone-linked care for cancer symptom monitoring: A pilot study, Cancer Pract 10 (3) (2002), pp. 147–154. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (30)
11 R.H. Friedman et al., The virtual visit: using telecommunications technology to take care of patients, J Am Med Inform Assoc 4 (1997), pp. 413–425. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (64)
12 A. Weaver et al., Application of mobile phone technology for managing chemotherapy-associated side-effects, Ann Oncol 18 (11) (2007), pp. 1887–1892. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (10)
13 D. Berry et al., Computerized symptom and quality-of-life assessment for patients with cancer: Part 1: Development and pilot testing, Oncol Nurs Forum 31(5 (2004), pp. E75–E83. Full Text via CrossRef
14 K. Mullen, D. Berry and B. Zierler, Computerized symptom and quality-of-life assessment for patients with cancer: Part II: Acceptability and usability, Oncol Nurs Forum 31 (5) (2004), pp. E84–E89. Full Text via CrossRef
15 B. Fortner et al., The Cancer Care Monitor: psychometric content evaluation and pilot testing of a computer administered system for symptom screening and quality of life in adult cancer patients, J Pain Symptom Manage 26 (6) (2003), pp. 1077–1092. Article |
16 R. de Bree et al., Touch screen computer-assisted health-related quality of life and distress data collection in head and neck cancer patients, Clin Otolaryngol 33 (2) (2008), pp. 138–142. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (6)
17 H. Huang et al., Developing a computerized data collection and decision support system for cancer pain management, Comput Inform Nurs 21 (4) (2003), pp. 206–217. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (17)
18 D.J. Wilkie et al., Usability of a computerized pain report in the general public with pain and people with cancer pain, J Pain Symptom Manage 25 (3) (2003), pp. 213–224. Article |
19 K. Kroenke et al., Effect of telecare management on pain and depression in patients with cancer: a randomized trial, JAMA 304 (2) (2010), pp. 163–171. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (7)
20 N. Kearney et al., Utilizing handheld computers to monitor and support patients receiving chemotherapy: results of a UK-based feasibility study, Support Care Cancer 14 (7) (2006), pp. 742–752. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (17)
21 N.R. Chumbler et al., Remote patient–provider communication and quality of life: empirical test of a dialogic model of cancer care, J Telemed Telecare 13 (2007), pp. 20–25. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (5)
22 A.L. Grubaugh et al., Attitudes toward medical and mental health care delivered via telehealth applications among rural and urban primary care patients, J Nerv Ment Dis 196 (2) (2008), pp. 166–170. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (6)
23 J. Stalfors et al., Accuracy of tele-oncology compared with face-to-face consultation in head and neck cancer case conferences, J Telemed Telecare 7 (2001), pp. 338–343. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (5)
24 C. Dorrian et al., Head and neck cancer assessment by flexible endoscopy and telemedicine, J Telemed Telecare 15 (2009), pp. 118–121. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (3)
25 J. Stalfors et al., Haptic palpation of head and neck cancer patients—implications for education and telemedicine, Stud Health Technol Inform 81 (2001), pp. 471–474. View Record in Scopus | Cited By in Scopus (8)
26 C. Myers, Telehealth applications in head and neck oncology, J Speech Lang Pathol Audiol 29 (3) (2005), pp. 125–127.
27 J.L. van den Brink et al., Involving the patient: a prospective study on use, appreciation and effectiveness of an information system in head and neck cancer care, Int J Med Inform 74 (10) (2005), pp. 839–849. Article |
28 J.L. van den Brink et al., Impact on quality of life of a telemedicine system supporting head and neck cancer patients: a controlled trial during the postoperative period at home, J Am Med Inform Assoc 14 (2) (2007), pp. 198–205. Article |
29 B. Head et al., Development of a telehhealth intervention for head and neck cancer patients, Telemed J E Health 15 (1) (2009), pp. 100–108. View Record in Scopus | Cited By in Scopus (1)
30 D.F. Cella et al., The Functional Assessment of Cancer Therapy (FACT) scale: development and validation of the general measure, J Clin Oncol 11 (3) (1993), pp. 570–579. View Record in Scopus | Cited By in Scopus (1626)
31 M.A. List et al., The Performance Status scale for head and neck cancer patients and the Functional Assessment of Cancer Therapy-Head and Neck scale: A study of utility and validity, Cancer 77 (11) (1996), pp. 2294–2301. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (169)
32 H.M. Mehanna and R.P. Morton, Patients' views on the utility of quality of life questionnaires in head and neck cancer: a randomised trial, Clin Otolaryngol 31 (4) (2006), pp. 310–316. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (10)
33 V. Chang et al., The Memorial Symptom Assessment Scale short form, Cancer 89 (2000), pp. 1162–1171. Full Text via CrossRef
34 R.K. Portenoy et al., The Memorial Symptom Assessment Scale: an instrument for the evaluation of symptom prevalence, characteristics and distress, Eur J Cancer 30A (9) (1994), pp. 1326–1336. Abstract |
35 J.E. Tranmer et al., Measuring the symptom experience of seriously ill cancer and noncancer hospitalized patients near the end of life with the Memorial Symptom Assessment Scale, J Pain Symptom Manage 25 (5) (2003), pp. 420–429. Article |
36 V.T. Chang et al., Symptom and quality of life survey of medical oncology patients at a Veterans Affairs medical center: a role for symptom assessment, Cancer 88 (5) (2000), pp. 1175–1183. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (121)
37 J.F. Nelson et al., The symptom burden of chronic critical illness, Crit Care Med 32 (7) (2004), pp. 1527–1534. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (55)
38 L.B. Harrison et al., Detailed quality of life assessment in patients treated with primary radiotherapy for squamous cell cancer of the base of the tongue, Head Neck 19 (3) (1997), pp. 169–175. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (132)
39 J. Sandberg et al., A qualitative study of the experiences and satisfaction of direct telemedicine providers in diabetes case management, Telemed J E Health 15 (8) (2009), pp. 742–750. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (1)
1 C.D. Llewellyn, M. McGurk and J. Weinman, Are psycho-social and behavioural factors related to health related-quality of life in patients with head and neck cancer?: A systematic review, Oral Oncol 41 (5) (2005), pp. 440–454. Article |
2 K.T. Vakharia, M.J. Ali and S.J. Wang, Quality-of-life impact of participation in a head and neck cancer support group, Otolaryngol Head Neck Surg 136 (3) (2007), pp. 405–410. Article |
3 P.J. Allison et al., Results of a feasibility study for a psycho-educational intervention in head and neck cancer, Psychooncology 13 (2004), pp. 482–485. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (22)
4 L.H. Karnell et al., Influence of social support on health-related quality of life outcomes in head and neck cancer, Head Neck 29 (2) (2007), pp. 143–146. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (19)
5 K.M. Petruson, E.M. Silander and E.B. Hammerlid, Effects of psychosocial intervention on quality of life in patients with head and neck cancer, Head Neck 25 (7) (2003), pp. 576–584. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (29)
6 J.R.J. deLeeuw et al., Negative and positive influences of social support on depression in patients with head and neck cancer: a prospective study, Psychooncology 9 (2000), pp. 20–28. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (46)
7 J. Ostroff et al., Interest in and barriers to participation in multiple family groups among head and neck cancer survivors and their primary family caregivers, Fam Process 43 (2) (2004), pp. 195–208. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (17)
8 R.L. Bashshur et al., National telemedicine initiatives: essential to healthcare reform, Telemed J E Health 15 (6) (2009), pp. 1–11.
9 K. Davis et al., An innovative symptom monitoring tool for people with advanced lung cancer: a pilot demonstration, J Support Oncol 5 (8) (2007), pp. 381–387. View Record in Scopus | Cited By in Scopus (8)
10 K.H. Mooney et al., Telephone-linked care for cancer symptom monitoring: A pilot study, Cancer Pract 10 (3) (2002), pp. 147–154. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (30)
11 R.H. Friedman et al., The virtual visit: using telecommunications technology to take care of patients, J Am Med Inform Assoc 4 (1997), pp. 413–425. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (64)
12 A. Weaver et al., Application of mobile phone technology for managing chemotherapy-associated side-effects, Ann Oncol 18 (11) (2007), pp. 1887–1892. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (10)
13 D. Berry et al., Computerized symptom and quality-of-life assessment for patients with cancer: Part 1: Development and pilot testing, Oncol Nurs Forum 31(5 (2004), pp. E75–E83. Full Text via CrossRef
14 K. Mullen, D. Berry and B. Zierler, Computerized symptom and quality-of-life assessment for patients with cancer: Part II: Acceptability and usability, Oncol Nurs Forum 31 (5) (2004), pp. E84–E89. Full Text via CrossRef
15 B. Fortner et al., The Cancer Care Monitor: psychometric content evaluation and pilot testing of a computer administered system for symptom screening and quality of life in adult cancer patients, J Pain Symptom Manage 26 (6) (2003), pp. 1077–1092. Article |
16 R. de Bree et al., Touch screen computer-assisted health-related quality of life and distress data collection in head and neck cancer patients, Clin Otolaryngol 33 (2) (2008), pp. 138–142. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (6)
17 H. Huang et al., Developing a computerized data collection and decision support system for cancer pain management, Comput Inform Nurs 21 (4) (2003), pp. 206–217. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (17)
18 D.J. Wilkie et al., Usability of a computerized pain report in the general public with pain and people with cancer pain, J Pain Symptom Manage 25 (3) (2003), pp. 213–224. Article |
19 K. Kroenke et al., Effect of telecare management on pain and depression in patients with cancer: a randomized trial, JAMA 304 (2) (2010), pp. 163–171. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (7)
20 N. Kearney et al., Utilizing handheld computers to monitor and support patients receiving chemotherapy: results of a UK-based feasibility study, Support Care Cancer 14 (7) (2006), pp. 742–752. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (17)
21 N.R. Chumbler et al., Remote patient–provider communication and quality of life: empirical test of a dialogic model of cancer care, J Telemed Telecare 13 (2007), pp. 20–25. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (5)
22 A.L. Grubaugh et al., Attitudes toward medical and mental health care delivered via telehealth applications among rural and urban primary care patients, J Nerv Ment Dis 196 (2) (2008), pp. 166–170. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (6)
23 J. Stalfors et al., Accuracy of tele-oncology compared with face-to-face consultation in head and neck cancer case conferences, J Telemed Telecare 7 (2001), pp. 338–343. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (5)
24 C. Dorrian et al., Head and neck cancer assessment by flexible endoscopy and telemedicine, J Telemed Telecare 15 (2009), pp. 118–121. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (3)
25 J. Stalfors et al., Haptic palpation of head and neck cancer patients—implications for education and telemedicine, Stud Health Technol Inform 81 (2001), pp. 471–474. View Record in Scopus | Cited By in Scopus (8)
26 C. Myers, Telehealth applications in head and neck oncology, J Speech Lang Pathol Audiol 29 (3) (2005), pp. 125–127.
27 J.L. van den Brink et al., Involving the patient: a prospective study on use, appreciation and effectiveness of an information system in head and neck cancer care, Int J Med Inform 74 (10) (2005), pp. 839–849. Article |
28 J.L. van den Brink et al., Impact on quality of life of a telemedicine system supporting head and neck cancer patients: a controlled trial during the postoperative period at home, J Am Med Inform Assoc 14 (2) (2007), pp. 198–205. Article |
29 B. Head et al., Development of a telehhealth intervention for head and neck cancer patients, Telemed J E Health 15 (1) (2009), pp. 100–108. View Record in Scopus | Cited By in Scopus (1)
30 D.F. Cella et al., The Functional Assessment of Cancer Therapy (FACT) scale: development and validation of the general measure, J Clin Oncol 11 (3) (1993), pp. 570–579. View Record in Scopus | Cited By in Scopus (1626)
31 M.A. List et al., The Performance Status scale for head and neck cancer patients and the Functional Assessment of Cancer Therapy-Head and Neck scale: A study of utility and validity, Cancer 77 (11) (1996), pp. 2294–2301. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (169)
32 H.M. Mehanna and R.P. Morton, Patients' views on the utility of quality of life questionnaires in head and neck cancer: a randomised trial, Clin Otolaryngol 31 (4) (2006), pp. 310–316. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (10)
33 V. Chang et al., The Memorial Symptom Assessment Scale short form, Cancer 89 (2000), pp. 1162–1171. Full Text via CrossRef
34 R.K. Portenoy et al., The Memorial Symptom Assessment Scale: an instrument for the evaluation of symptom prevalence, characteristics and distress, Eur J Cancer 30A (9) (1994), pp. 1326–1336. Abstract |
35 J.E. Tranmer et al., Measuring the symptom experience of seriously ill cancer and noncancer hospitalized patients near the end of life with the Memorial Symptom Assessment Scale, J Pain Symptom Manage 25 (5) (2003), pp. 420–429. Article |
36 V.T. Chang et al., Symptom and quality of life survey of medical oncology patients at a Veterans Affairs medical center: a role for symptom assessment, Cancer 88 (5) (2000), pp. 1175–1183. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (121)
37 J.F. Nelson et al., The symptom burden of chronic critical illness, Crit Care Med 32 (7) (2004), pp. 1527–1534. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (55)
38 L.B. Harrison et al., Detailed quality of life assessment in patients treated with primary radiotherapy for squamous cell cancer of the base of the tongue, Head Neck 19 (3) (1997), pp. 169–175. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (132)
39 J. Sandberg et al., A qualitative study of the experiences and satisfaction of direct telemedicine providers in diabetes case management, Telemed J E Health 15 (8) (2009), pp. 742–750. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (1)
Head & Neck Cancers
Dr. Ajani Nugent of Emory University in Atlanta discusses the need for better education about head and neck cancers in underserved communities. GMNN's Heidi Splete reports from the Triological Society's combined sections meeting.
Dr. Ajani Nugent of Emory University in Atlanta discusses the need for better education about head and neck cancers in underserved communities. GMNN's Heidi Splete reports from the Triological Society's combined sections meeting.
Dr. Ajani Nugent of Emory University in Atlanta discusses the need for better education about head and neck cancers in underserved communities. GMNN's Heidi Splete reports from the Triological Society's combined sections meeting.
Cetuximab and Chemoradiation
Dr. Harold J. Wanebo reports that a neoadjuvant regimen of cetuximab and chemoradiation was linked to significant downstaging of locally advanced esophageal cancer. Bob Finn of Elsevier Global Medical News (EGMN) reports from a meeting on gastrointestinal cancer sponsored by the American Society of Clinical Oncology.
Dr. Harold J. Wanebo reports that a neoadjuvant regimen of cetuximab and chemoradiation was linked to significant downstaging of locally advanced esophageal cancer. Bob Finn of Elsevier Global Medical News (EGMN) reports from a meeting on gastrointestinal cancer sponsored by the American Society of Clinical Oncology.
Dr. Harold J. Wanebo reports that a neoadjuvant regimen of cetuximab and chemoradiation was linked to significant downstaging of locally advanced esophageal cancer. Bob Finn of Elsevier Global Medical News (EGMN) reports from a meeting on gastrointestinal cancer sponsored by the American Society of Clinical Oncology.