The Journal of Community and Supportive Oncology

CIPN is defined as the damage to the peripheral nervous system experienced by patients receiving neurotoxic chemotherapies. The symptoms of CIPN range from burning, stabbing, pricking, tingling, or numbness in the toes and fingers to generalized symptoms that may be immobilizing.^{[1], [2] and [3]} While each chemotherapy agent has its own mechanism of action, CIPN generally affects the fingers and toes first; and with cumulative doses, symptoms progress proximally to the hands and feet, arms and ankles, and then calves (stocking-glove distribution).^{[3] and [4]} Sensory symptoms and signs typically develop before motor symptoms, and a subset of patients also suffer from neuropathic pain. CIPN occurrence estimates have ranged from 10% to 92% and vary depending on the chemotherapy regimen, dosing, and comorbidity. Patients with preexisting peripheral neuropathy are more likely to develop a severe and persistent CIPN compared to those without any history of neuropathy.⁵

Although several agents show promise in preventing CIPN, the evidence of the efficacy of these options is mixed, and treatment of CIPN is still largely symptomatic. Corticosteroids, antidepressants, anticonvulsants, and analgesics are potential options available to clinicians, although none has shown significant efficacy in treating CIPN symptoms. As a result, in the event of significant neuropathy, dose reduction or discontinuing chemotherapy is the only option to stop and reverse progression of peripheral neuropathy; and such steps potentially could impact overall cancer treatment outcomes.^{[6], [7] and [8]} Alternatively, patients may choose to continue chemotherapy with compromised HRQL; specific reductions in HRQL scores due to CIPN symptoms have been estimated to be from 15% to 20%.⁹

A key issue for clinicians is understanding the extent of functional impairment a given patient may have when experiencing CIPN. Although physicians often are able to diagnose severe symptoms more accurately relative to less severe CIPN symptoms, Postma and colleagues¹⁰ and other researchers have shown that there is substantial discrepancy in severity grading among physicians as well as between patients and physicians, with physicians often underestimating the severity of symptoms. Contributing to this problem is the lack of consistency in diagnostic tools used, with no gold standard for CIPN measurement. This review therefore examines the symptoms and impacts of CIPN from the patient perspective, identifies concepts and issues that should be considered when evaluating CIPN, and compares existing patient-reported outcomes (PRO) measures that have been used in CIPN assessment.

Methods

The review of the literature, performed in January 2009, focused on abstracts or articles that assessed the HRQL of CIPN over the past 5 years. The review included six article databases (OVID, which includes Medline and Embase; Proquest digital dissertations; CINHAL; IPA; Health and psychological instruments; Psycharticles) and five conference proceedings (ASCO, AACR, NCRI, San Antonio Breast Cancer Symposium, Annual Symposia of the American Society of Breast Disease). The comprehensive search combined the clinical terms “peripheral neuropathy,” “neurotoxicity,” “paresthesias,” “dysesthesias,” etc. with the term “chemotherapy” and with specific chemotherapy drugs (eg, cisplatin, paclitaxel, vincristine). These terms were further combined with quality of life (eg, preference, quality of life, patient perspective, daily activities). Only those studies focusing on neuropathy related to chemotherapy were included in this review; studies of diabetes, acquired immunodeficiency syndrome (AIDS), B₁₂ deficiency, or arthritis-related neuropathy were excluded.

A total of 5,671 studies across the article databases and 355 conference abstracts underwent initial review. After removing duplicates, commentaries, review articles, and articles discussing neuropathy associated with diabetes, human immunodeficiency virus (HIV), and rheumatoid arthritis, 41 potentially relevant abstracts were identified, and full-text article paper copies were obtained for these studies. The final review then identified 31 articles and 10 relevant conference abstracts to be incorporated.

Results

The findings from this review are discussed in three sections: (1) qualitative studies, (2) patient preference studies, and (3) PRO measures used to assess CIPN outcomes.

Qualitative Studies

Four qualitative studies were identified in which CIPN was discussed.^{[11], [12], [13] and [14]} Bakitas¹¹ evaluated CIPN experience among patients of all cancer types, while the other three studies examined the effects of a range of chemotherapy side effects in disease-specific populations, including breast cancer¹² and colorectal cancer.^{[13] and [14]}

In summary, the qualitative studies showed that CIPN can lead to a range of physical and emotional impacts. Patients with CIPN indicated that they experienced tingling, burning, numbness, “pins and needles,” and shock-like or painful sensations bilaterally in the feet and/or hands. Patients indicated that of all chemotherapy-related adverse events, CIPN was one of the least expected and most distressing and disabling.^{[11], [12] and [14]} Upper-extremity neuropathy interfered with dressing, cooking, sewing, household work, and leisure. Problems with dressing included difficulty putting on undergarments or jewelry. Neuropathy in the lower extremities caused problems with walking (“I walk like I'm drunk,” “I feel clumsy”) and was accompanied by problems with balance, ambulation (hiking, running, biking, and standing for long periods), and driving.^{[11] and [12]} Among breast cancer patients on paclitaxel, peripheral neuropathy was considered to be more incapacitating than bone pain because it affected daily functioning, whereas bone pain generally did not.¹²

The symptoms of CIPN not only resulted in physical distress and loss of functional ability but also affected emotional health and social interactions. Patients expressed that they were often ill-prepared to cope with CIPN symptoms. The functional impairments (ie, inability to pursue daily activities) affected patients' mood and often made patients feel dependent, disabled, and helpless. Subjects reported social isolation when they could not drive, walk, or stand for periods of time.¹¹

Patients also expressed difficulty in describing symptoms, which were often described as “funny,” “strange,” or “weird.” Without the ability to communicate symptoms to their doctors, some patients expressed a feeling of frustration that their doctors did not take their symptoms seriously.¹¹ Patients also felt disappointment about their lack of understanding of the significance of some CIPN-related symptoms over others and the prolonged duration for symptom resolution.^{[12], [13] and [14]}

Nevertheless, patients generally could keep CIPN “in the background,” although it could be “annoying,” “distracting,” and “unpleasant.”¹¹ Despite the many disruptions associated with CIPN, patients expressed reluctance in discontinuing chemotherapy and generally adapted and “learned to live with” their CIPN.^{[11], [12] and [14]} As observed by Calhoun and colleagues,¹⁵ who conducted a patient preference study of chemotherapy toxicity states, patients appear to be willing to tolerate more toxicity in expectation of better chemotherapy outcomes.

Patient Preference Studies

Four patient preference studies echoed sentiments expressed in the qualitative studies regarding apprehension about chemotherapy-induced neurotoxicities. In general, the patient preference studies reported that peripheral neuropathy was viewed as worse than a number of other chemotherapy-induced toxicities. In a study in which ovarian cancer patients rated selected toxicities on a visual analog scale where 0.0 reflected the worst chemotherapy scenario and 1.0 reflected an ideal chemotherapy scenario, “peripheral neuropathy” was rated as 0.45 and was considered worse than alopecia, pancytopenia, and fatigue.¹⁶

Another study that included ovarian cancer patients used the time trade-off technique to assess preferences for different health states representing five different levels of severity each for neurotoxicity, nephrotoxicity, and ototoxicity. Whereas the two more mild levels of these toxicities were rated similarly, the patients consistently rated the three moderate to severe levels for neurotoxicity as worse than those for nephrotoxicity and ototoxicity. Patients with previous toxicity experience rated all toxicity scenarios worse than those without any previous experience.¹⁵

Similarly, Dranitsaris¹⁷ elicited rankings from the Canadian general population with respect to the importance of reducing the chance of febrile neutropenia, neurotoxicity, and renal toxicity. The general population felt that it was more important to reduce the chance of neurotoxicity versus renal toxicity. In a more recent study, Dranitsaris and colleagues¹⁸ assessed the perspectives of oncology pharmacists and nurses who served as proxies for patients regarding grade 2/3 motor neuropathy, grade 2/3 sensory neuropathy, grade 3/4 neutropenia, and grade 3/4 anemia. Of these four toxicities, the clinicians rated motor neuropathy and sensory neuropathy the most unpleasant. The clinicians preferred docetaxel in place of paclitaxel, the former being associated with smaller chances of sensory neuropathy and motor neuropathy but not neutropenia or anemia. Based on qualitative feedback, the respondents explained that they had long-term concerns about neuropathy because it could not be effectively managed but that neutropenia and anemia were short-term, treatable events.¹⁸

PRO Measures for CIPN Evaluation

Generic PRO measures focus broadly on functional status and can also be used to compare physical and mental health functioning across patient populations. However, they may not be sensitive enough to capture impacts of specific health conditions. This lack of sensitivity to disease-specific impacts has been observed in a number of oncology studies with respect to the occurrence of CIPN. Specifically, the generic measures the European Organization for Research and Treatment in Cancer—Quality of Life Questionnaire (EORTC QLQ-C30) and the Functional Assessment of Cancer Therapy (FACT)—General typically do not detect differences between treatment groups, although the incidence and severity of neurotoxicity may differ significantly as measured using National Cancer Institute Common Toxicity Criteria (NCI-CTC) or other criteria.^{[6], [19], [20] and [21]} The lack of sensitivity of generic measures to treatment group differences in CIPN impacts likely is attributable to insufficient numbers experiencing neurotoxicity-related impediments to daily functioning and/or to the imprecision of these measures.^{[19] and [20]}

However, CIPN-specific measures or items do show sensitivity to treatment differences in CIPN occurrence and impacts. Seven PRO measures have been used to specifically assess CIPN outcomes (Table 1).

CIPN is defined as the damage to the peripheral nervous system experienced by patients receiving neurotoxic chemotherapies. The symptoms of CIPN range from burning, stabbing, pricking, tingling, or numbness in the toes and fingers to generalized symptoms that may be immobilizing.^{[1], [2] and [3]} While each chemotherapy agent has its own mechanism of action, CIPN generally affects the fingers and toes first; and with cumulative doses, symptoms progress proximally to the hands and feet, arms and ankles, and then calves (stocking-glove distribution).^{[3] and [4]} Sensory symptoms and signs typically develop before motor symptoms, and a subset of patients also suffer from neuropathic pain. CIPN occurrence estimates have ranged from 10% to 92% and vary depending on the chemotherapy regimen, dosing, and comorbidity. Patients with preexisting peripheral neuropathy are more likely to develop a severe and persistent CIPN compared to those without any history of neuropathy.⁵

Although several agents show promise in preventing CIPN, the evidence of the efficacy of these options is mixed, and treatment of CIPN is still largely symptomatic. Corticosteroids, antidepressants, anticonvulsants, and analgesics are potential options available to clinicians, although none has shown significant efficacy in treating CIPN symptoms. As a result, in the event of significant neuropathy, dose reduction or discontinuing chemotherapy is the only option to stop and reverse progression of peripheral neuropathy; and such steps potentially could impact overall cancer treatment outcomes.^{[6], [7] and [8]} Alternatively, patients may choose to continue chemotherapy with compromised HRQL; specific reductions in HRQL scores due to CIPN symptoms have been estimated to be from 15% to 20%.⁹

A key issue for clinicians is understanding the extent of functional impairment a given patient may have when experiencing CIPN. Although physicians often are able to diagnose severe symptoms more accurately relative to less severe CIPN symptoms, Postma and colleagues¹⁰ and other researchers have shown that there is substantial discrepancy in severity grading among physicians as well as between patients and physicians, with physicians often underestimating the severity of symptoms. Contributing to this problem is the lack of consistency in diagnostic tools used, with no gold standard for CIPN measurement. This review therefore examines the symptoms and impacts of CIPN from the patient perspective, identifies concepts and issues that should be considered when evaluating CIPN, and compares existing patient-reported outcomes (PRO) measures that have been used in CIPN assessment.

Methods

The review of the literature, performed in January 2009, focused on abstracts or articles that assessed the HRQL of CIPN over the past 5 years. The review included six article databases (OVID, which includes Medline and Embase; Proquest digital dissertations; CINHAL; IPA; Health and psychological instruments; Psycharticles) and five conference proceedings (ASCO, AACR, NCRI, San Antonio Breast Cancer Symposium, Annual Symposia of the American Society of Breast Disease). The comprehensive search combined the clinical terms “peripheral neuropathy,” “neurotoxicity,” “paresthesias,” “dysesthesias,” etc. with the term “chemotherapy” and with specific chemotherapy drugs (eg, cisplatin, paclitaxel, vincristine). These terms were further combined with quality of life (eg, preference, quality of life, patient perspective, daily activities). Only those studies focusing on neuropathy related to chemotherapy were included in this review; studies of diabetes, acquired immunodeficiency syndrome (AIDS), B₁₂ deficiency, or arthritis-related neuropathy were excluded.

A total of 5,671 studies across the article databases and 355 conference abstracts underwent initial review. After removing duplicates, commentaries, review articles, and articles discussing neuropathy associated with diabetes, human immunodeficiency virus (HIV), and rheumatoid arthritis, 41 potentially relevant abstracts were identified, and full-text article paper copies were obtained for these studies. The final review then identified 31 articles and 10 relevant conference abstracts to be incorporated.

Results

The findings from this review are discussed in three sections: (1) qualitative studies, (2) patient preference studies, and (3) PRO measures used to assess CIPN outcomes.

Qualitative Studies

Four qualitative studies were identified in which CIPN was discussed.^{[11], [12], [13] and [14]} Bakitas¹¹ evaluated CIPN experience among patients of all cancer types, while the other three studies examined the effects of a range of chemotherapy side effects in disease-specific populations, including breast cancer¹² and colorectal cancer.^{[13] and [14]}

In summary, the qualitative studies showed that CIPN can lead to a range of physical and emotional impacts. Patients with CIPN indicated that they experienced tingling, burning, numbness, “pins and needles,” and shock-like or painful sensations bilaterally in the feet and/or hands. Patients indicated that of all chemotherapy-related adverse events, CIPN was one of the least expected and most distressing and disabling.^{[11], [12] and [14]} Upper-extremity neuropathy interfered with dressing, cooking, sewing, household work, and leisure. Problems with dressing included difficulty putting on undergarments or jewelry. Neuropathy in the lower extremities caused problems with walking (“I walk like I'm drunk,” “I feel clumsy”) and was accompanied by problems with balance, ambulation (hiking, running, biking, and standing for long periods), and driving.^{[11] and [12]} Among breast cancer patients on paclitaxel, peripheral neuropathy was considered to be more incapacitating than bone pain because it affected daily functioning, whereas bone pain generally did not.¹²

The symptoms of CIPN not only resulted in physical distress and loss of functional ability but also affected emotional health and social interactions. Patients expressed that they were often ill-prepared to cope with CIPN symptoms. The functional impairments (ie, inability to pursue daily activities) affected patients' mood and often made patients feel dependent, disabled, and helpless. Subjects reported social isolation when they could not drive, walk, or stand for periods of time.¹¹

Patients also expressed difficulty in describing symptoms, which were often described as “funny,” “strange,” or “weird.” Without the ability to communicate symptoms to their doctors, some patients expressed a feeling of frustration that their doctors did not take their symptoms seriously.¹¹ Patients also felt disappointment about their lack of understanding of the significance of some CIPN-related symptoms over others and the prolonged duration for symptom resolution.^{[12], [13] and [14]}

Nevertheless, patients generally could keep CIPN “in the background,” although it could be “annoying,” “distracting,” and “unpleasant.”¹¹ Despite the many disruptions associated with CIPN, patients expressed reluctance in discontinuing chemotherapy and generally adapted and “learned to live with” their CIPN.^{[11], [12] and [14]} As observed by Calhoun and colleagues,¹⁵ who conducted a patient preference study of chemotherapy toxicity states, patients appear to be willing to tolerate more toxicity in expectation of better chemotherapy outcomes.

Patient Preference Studies

Four patient preference studies echoed sentiments expressed in the qualitative studies regarding apprehension about chemotherapy-induced neurotoxicities. In general, the patient preference studies reported that peripheral neuropathy was viewed as worse than a number of other chemotherapy-induced toxicities. In a study in which ovarian cancer patients rated selected toxicities on a visual analog scale where 0.0 reflected the worst chemotherapy scenario and 1.0 reflected an ideal chemotherapy scenario, “peripheral neuropathy” was rated as 0.45 and was considered worse than alopecia, pancytopenia, and fatigue.¹⁶

Another study that included ovarian cancer patients used the time trade-off technique to assess preferences for different health states representing five different levels of severity each for neurotoxicity, nephrotoxicity, and ototoxicity. Whereas the two more mild levels of these toxicities were rated similarly, the patients consistently rated the three moderate to severe levels for neurotoxicity as worse than those for nephrotoxicity and ototoxicity. Patients with previous toxicity experience rated all toxicity scenarios worse than those without any previous experience.¹⁵

Similarly, Dranitsaris¹⁷ elicited rankings from the Canadian general population with respect to the importance of reducing the chance of febrile neutropenia, neurotoxicity, and renal toxicity. The general population felt that it was more important to reduce the chance of neurotoxicity versus renal toxicity. In a more recent study, Dranitsaris and colleagues¹⁸ assessed the perspectives of oncology pharmacists and nurses who served as proxies for patients regarding grade 2/3 motor neuropathy, grade 2/3 sensory neuropathy, grade 3/4 neutropenia, and grade 3/4 anemia. Of these four toxicities, the clinicians rated motor neuropathy and sensory neuropathy the most unpleasant. The clinicians preferred docetaxel in place of paclitaxel, the former being associated with smaller chances of sensory neuropathy and motor neuropathy but not neutropenia or anemia. Based on qualitative feedback, the respondents explained that they had long-term concerns about neuropathy because it could not be effectively managed but that neutropenia and anemia were short-term, treatable events.¹⁸

PRO Measures for CIPN Evaluation

Generic PRO measures focus broadly on functional status and can also be used to compare physical and mental health functioning across patient populations. However, they may not be sensitive enough to capture impacts of specific health conditions. This lack of sensitivity to disease-specific impacts has been observed in a number of oncology studies with respect to the occurrence of CIPN. Specifically, the generic measures the European Organization for Research and Treatment in Cancer—Quality of Life Questionnaire (EORTC QLQ-C30) and the Functional Assessment of Cancer Therapy (FACT)—General typically do not detect differences between treatment groups, although the incidence and severity of neurotoxicity may differ significantly as measured using National Cancer Institute Common Toxicity Criteria (NCI-CTC) or other criteria.^{[6], [19], [20] and [21]} The lack of sensitivity of generic measures to treatment group differences in CIPN impacts likely is attributable to insufficient numbers experiencing neurotoxicity-related impediments to daily functioning and/or to the imprecision of these measures.^{[19] and [20]}

However, CIPN-specific measures or items do show sensitivity to treatment differences in CIPN occurrence and impacts. Seven PRO measures have been used to specifically assess CIPN outcomes (Table 1).

CIPN is defined as the damage to the peripheral nervous system experienced by patients receiving neurotoxic chemotherapies. The symptoms of CIPN range from burning, stabbing, pricking, tingling, or numbness in the toes and fingers to generalized symptoms that may be immobilizing.^{[1], [2] and [3]} While each chemotherapy agent has its own mechanism of action, CIPN generally affects the fingers and toes first; and with cumulative doses, symptoms progress proximally to the hands and feet, arms and ankles, and then calves (stocking-glove distribution).^{[3] and [4]} Sensory symptoms and signs typically develop before motor symptoms, and a subset of patients also suffer from neuropathic pain. CIPN occurrence estimates have ranged from 10% to 92% and vary depending on the chemotherapy regimen, dosing, and comorbidity. Patients with preexisting peripheral neuropathy are more likely to develop a severe and persistent CIPN compared to those without any history of neuropathy.⁵

Although several agents show promise in preventing CIPN, the evidence of the efficacy of these options is mixed, and treatment of CIPN is still largely symptomatic. Corticosteroids, antidepressants, anticonvulsants, and analgesics are potential options available to clinicians, although none has shown significant efficacy in treating CIPN symptoms. As a result, in the event of significant neuropathy, dose reduction or discontinuing chemotherapy is the only option to stop and reverse progression of peripheral neuropathy; and such steps potentially could impact overall cancer treatment outcomes.^{[6], [7] and [8]} Alternatively, patients may choose to continue chemotherapy with compromised HRQL; specific reductions in HRQL scores due to CIPN symptoms have been estimated to be from 15% to 20%.⁹

A key issue for clinicians is understanding the extent of functional impairment a given patient may have when experiencing CIPN. Although physicians often are able to diagnose severe symptoms more accurately relative to less severe CIPN symptoms, Postma and colleagues¹⁰ and other researchers have shown that there is substantial discrepancy in severity grading among physicians as well as between patients and physicians, with physicians often underestimating the severity of symptoms. Contributing to this problem is the lack of consistency in diagnostic tools used, with no gold standard for CIPN measurement. This review therefore examines the symptoms and impacts of CIPN from the patient perspective, identifies concepts and issues that should be considered when evaluating CIPN, and compares existing patient-reported outcomes (PRO) measures that have been used in CIPN assessment.

Methods

The review of the literature, performed in January 2009, focused on abstracts or articles that assessed the HRQL of CIPN over the past 5 years. The review included six article databases (OVID, which includes Medline and Embase; Proquest digital dissertations; CINHAL; IPA; Health and psychological instruments; Psycharticles) and five conference proceedings (ASCO, AACR, NCRI, San Antonio Breast Cancer Symposium, Annual Symposia of the American Society of Breast Disease). The comprehensive search combined the clinical terms “peripheral neuropathy,” “neurotoxicity,” “paresthesias,” “dysesthesias,” etc. with the term “chemotherapy” and with specific chemotherapy drugs (eg, cisplatin, paclitaxel, vincristine). These terms were further combined with quality of life (eg, preference, quality of life, patient perspective, daily activities). Only those studies focusing on neuropathy related to chemotherapy were included in this review; studies of diabetes, acquired immunodeficiency syndrome (AIDS), B₁₂ deficiency, or arthritis-related neuropathy were excluded.

A total of 5,671 studies across the article databases and 355 conference abstracts underwent initial review. After removing duplicates, commentaries, review articles, and articles discussing neuropathy associated with diabetes, human immunodeficiency virus (HIV), and rheumatoid arthritis, 41 potentially relevant abstracts were identified, and full-text article paper copies were obtained for these studies. The final review then identified 31 articles and 10 relevant conference abstracts to be incorporated.

Results

The findings from this review are discussed in three sections: (1) qualitative studies, (2) patient preference studies, and (3) PRO measures used to assess CIPN outcomes.

Qualitative Studies

Four qualitative studies were identified in which CIPN was discussed.^{[11], [12], [13] and [14]} Bakitas¹¹ evaluated CIPN experience among patients of all cancer types, while the other three studies examined the effects of a range of chemotherapy side effects in disease-specific populations, including breast cancer¹² and colorectal cancer.^{[13] and [14]}

In summary, the qualitative studies showed that CIPN can lead to a range of physical and emotional impacts. Patients with CIPN indicated that they experienced tingling, burning, numbness, “pins and needles,” and shock-like or painful sensations bilaterally in the feet and/or hands. Patients indicated that of all chemotherapy-related adverse events, CIPN was one of the least expected and most distressing and disabling.^{[11], [12] and [14]} Upper-extremity neuropathy interfered with dressing, cooking, sewing, household work, and leisure. Problems with dressing included difficulty putting on undergarments or jewelry. Neuropathy in the lower extremities caused problems with walking (“I walk like I'm drunk,” “I feel clumsy”) and was accompanied by problems with balance, ambulation (hiking, running, biking, and standing for long periods), and driving.^{[11] and [12]} Among breast cancer patients on paclitaxel, peripheral neuropathy was considered to be more incapacitating than bone pain because it affected daily functioning, whereas bone pain generally did not.¹²

The symptoms of CIPN not only resulted in physical distress and loss of functional ability but also affected emotional health and social interactions. Patients expressed that they were often ill-prepared to cope with CIPN symptoms. The functional impairments (ie, inability to pursue daily activities) affected patients' mood and often made patients feel dependent, disabled, and helpless. Subjects reported social isolation when they could not drive, walk, or stand for periods of time.¹¹

Patients also expressed difficulty in describing symptoms, which were often described as “funny,” “strange,” or “weird.” Without the ability to communicate symptoms to their doctors, some patients expressed a feeling of frustration that their doctors did not take their symptoms seriously.¹¹ Patients also felt disappointment about their lack of understanding of the significance of some CIPN-related symptoms over others and the prolonged duration for symptom resolution.^{[12], [13] and [14]}

Nevertheless, patients generally could keep CIPN “in the background,” although it could be “annoying,” “distracting,” and “unpleasant.”¹¹ Despite the many disruptions associated with CIPN, patients expressed reluctance in discontinuing chemotherapy and generally adapted and “learned to live with” their CIPN.^{[11], [12] and [14]} As observed by Calhoun and colleagues,¹⁵ who conducted a patient preference study of chemotherapy toxicity states, patients appear to be willing to tolerate more toxicity in expectation of better chemotherapy outcomes.

Patient Preference Studies

Four patient preference studies echoed sentiments expressed in the qualitative studies regarding apprehension about chemotherapy-induced neurotoxicities. In general, the patient preference studies reported that peripheral neuropathy was viewed as worse than a number of other chemotherapy-induced toxicities. In a study in which ovarian cancer patients rated selected toxicities on a visual analog scale where 0.0 reflected the worst chemotherapy scenario and 1.0 reflected an ideal chemotherapy scenario, “peripheral neuropathy” was rated as 0.45 and was considered worse than alopecia, pancytopenia, and fatigue.¹⁶

Another study that included ovarian cancer patients used the time trade-off technique to assess preferences for different health states representing five different levels of severity each for neurotoxicity, nephrotoxicity, and ototoxicity. Whereas the two more mild levels of these toxicities were rated similarly, the patients consistently rated the three moderate to severe levels for neurotoxicity as worse than those for nephrotoxicity and ototoxicity. Patients with previous toxicity experience rated all toxicity scenarios worse than those without any previous experience.¹⁵

Similarly, Dranitsaris¹⁷ elicited rankings from the Canadian general population with respect to the importance of reducing the chance of febrile neutropenia, neurotoxicity, and renal toxicity. The general population felt that it was more important to reduce the chance of neurotoxicity versus renal toxicity. In a more recent study, Dranitsaris and colleagues¹⁸ assessed the perspectives of oncology pharmacists and nurses who served as proxies for patients regarding grade 2/3 motor neuropathy, grade 2/3 sensory neuropathy, grade 3/4 neutropenia, and grade 3/4 anemia. Of these four toxicities, the clinicians rated motor neuropathy and sensory neuropathy the most unpleasant. The clinicians preferred docetaxel in place of paclitaxel, the former being associated with smaller chances of sensory neuropathy and motor neuropathy but not neutropenia or anemia. Based on qualitative feedback, the respondents explained that they had long-term concerns about neuropathy because it could not be effectively managed but that neutropenia and anemia were short-term, treatable events.¹⁸

PRO Measures for CIPN Evaluation

Generic PRO measures focus broadly on functional status and can also be used to compare physical and mental health functioning across patient populations. However, they may not be sensitive enough to capture impacts of specific health conditions. This lack of sensitivity to disease-specific impacts has been observed in a number of oncology studies with respect to the occurrence of CIPN. Specifically, the generic measures the European Organization for Research and Treatment in Cancer—Quality of Life Questionnaire (EORTC QLQ-C30) and the Functional Assessment of Cancer Therapy (FACT)—General typically do not detect differences between treatment groups, although the incidence and severity of neurotoxicity may differ significantly as measured using National Cancer Institute Common Toxicity Criteria (NCI-CTC) or other criteria.^{[6], [19], [20] and [21]} The lack of sensitivity of generic measures to treatment group differences in CIPN impacts likely is attributable to insufficient numbers experiencing neurotoxicity-related impediments to daily functioning and/or to the imprecision of these measures.^{[19] and [20]}

However, CIPN-specific measures or items do show sensitivity to treatment differences in CIPN occurrence and impacts. Seven PRO measures have been used to specifically assess CIPN outcomes (Table 1).

Patient safety goals recently issued by the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) and current Centers for Disease Control and Prevention (CDC) guidelines recommend vaccinations for all cancer patients over the ages of 65 (for pneumococcus) and 50 (annually, for influenza).^{[4] and [5]} Moreover, in a recent review, Pollyea et al.² reported that vaccination against seasonal influenza is indicated in immunocompromised patients, including those receiving anticancer chemotherapy, irrespective of their age.

However, there is some uncertainty among oncologists about the safety and efficacy of this procedure. Evidence indicates that fewer than 50% of patients treated with chemotherapy actually receive a vaccination.⁶ As published by Yee et al.,¹ 30% of patients treated with radiotherapy reported never receiving the influenza vaccine and only 7% of patients reported being asked or informed about the vaccination by their oncologists.

This uncertainty is probably due to several limitations in the available studies on this subject.² Considering these limitations, we carried out an observational monocentric study to evaluate influenza vaccine efficacy and safety in patients undergoing chemotherapy.

We included patients who received an influenza vaccination in November 2008 during chemotherapy treatment. In January–February 2009, we collected the patients' clinical information about cancer disease (type and stage), chemotherapy treatment (adjuvant or palliative treatment, line of therapy), comorbidities, concomitant medications, and previous seasonal influenza vaccination. In March 2009, eligible patients were interviewed to determine if they had contracted influenza (according to the WHO definition: sudden onset of fever >38°, with at least one general symptom such as aching muscles, headache, and malaise and at least one respiratory symptom such as nonproductive cough, sore throat, and rhinitis) and developed a vaccination reaction.

Seventy-two patients, including 38 (52%) females with a median age of 69 years, received vaccination during chemotherapy. Thirty (42%) patients were treated with adjuvant chemotherapy and 42 (58%) for locally advanced or metastatic disease. Twenty-five (35%) patients were treated for gastrointestinal, 17 (24%) for breast, 14 (19%) for urogenital, and 11 (15%) for lung cancers, as well as four for other solid tumors. Eighteen (25%) patients received vaccination for the first time. We found seven (9%) cases of influenza and only three (4%) vaccination reactions (transient muscle soreness, arthralgias, and fever). Considering our results in terms of efficacy and safety, routine vaccination against influenza virus should be considered in patients undergoing chemotherapy.

Our observations have several limitations, represented, in particular, by the absence of a control, nonvaccinated group and of a “true” measure of efficacy vaccination (such as serological response). Nevertheless, the limited sample size, the heterogeneity of the available studies, and the absence of a randomized controlled trial make even an observational study, such as that reported by our institution, valuable.

Patient safety goals recently issued by the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) and current Centers for Disease Control and Prevention (CDC) guidelines recommend vaccinations for all cancer patients over the ages of 65 (for pneumococcus) and 50 (annually, for influenza).^{[4] and [5]} Moreover, in a recent review, Pollyea et al.² reported that vaccination against seasonal influenza is indicated in immunocompromised patients, including those receiving anticancer chemotherapy, irrespective of their age.

However, there is some uncertainty among oncologists about the safety and efficacy of this procedure. Evidence indicates that fewer than 50% of patients treated with chemotherapy actually receive a vaccination.⁶ As published by Yee et al.,¹ 30% of patients treated with radiotherapy reported never receiving the influenza vaccine and only 7% of patients reported being asked or informed about the vaccination by their oncologists.

This uncertainty is probably due to several limitations in the available studies on this subject.² Considering these limitations, we carried out an observational monocentric study to evaluate influenza vaccine efficacy and safety in patients undergoing chemotherapy.

We included patients who received an influenza vaccination in November 2008 during chemotherapy treatment. In January–February 2009, we collected the patients' clinical information about cancer disease (type and stage), chemotherapy treatment (adjuvant or palliative treatment, line of therapy), comorbidities, concomitant medications, and previous seasonal influenza vaccination. In March 2009, eligible patients were interviewed to determine if they had contracted influenza (according to the WHO definition: sudden onset of fever >38°, with at least one general symptom such as aching muscles, headache, and malaise and at least one respiratory symptom such as nonproductive cough, sore throat, and rhinitis) and developed a vaccination reaction.

Seventy-two patients, including 38 (52%) females with a median age of 69 years, received vaccination during chemotherapy. Thirty (42%) patients were treated with adjuvant chemotherapy and 42 (58%) for locally advanced or metastatic disease. Twenty-five (35%) patients were treated for gastrointestinal, 17 (24%) for breast, 14 (19%) for urogenital, and 11 (15%) for lung cancers, as well as four for other solid tumors. Eighteen (25%) patients received vaccination for the first time. We found seven (9%) cases of influenza and only three (4%) vaccination reactions (transient muscle soreness, arthralgias, and fever). Considering our results in terms of efficacy and safety, routine vaccination against influenza virus should be considered in patients undergoing chemotherapy.

Our observations have several limitations, represented, in particular, by the absence of a control, nonvaccinated group and of a “true” measure of efficacy vaccination (such as serological response). Nevertheless, the limited sample size, the heterogeneity of the available studies, and the absence of a randomized controlled trial make even an observational study, such as that reported by our institution, valuable.

Patient safety goals recently issued by the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) and current Centers for Disease Control and Prevention (CDC) guidelines recommend vaccinations for all cancer patients over the ages of 65 (for pneumococcus) and 50 (annually, for influenza).^{[4] and [5]} Moreover, in a recent review, Pollyea et al.² reported that vaccination against seasonal influenza is indicated in immunocompromised patients, including those receiving anticancer chemotherapy, irrespective of their age.

However, there is some uncertainty among oncologists about the safety and efficacy of this procedure. Evidence indicates that fewer than 50% of patients treated with chemotherapy actually receive a vaccination.⁶ As published by Yee et al.,¹ 30% of patients treated with radiotherapy reported never receiving the influenza vaccine and only 7% of patients reported being asked or informed about the vaccination by their oncologists.

This uncertainty is probably due to several limitations in the available studies on this subject.² Considering these limitations, we carried out an observational monocentric study to evaluate influenza vaccine efficacy and safety in patients undergoing chemotherapy.

We included patients who received an influenza vaccination in November 2008 during chemotherapy treatment. In January–February 2009, we collected the patients' clinical information about cancer disease (type and stage), chemotherapy treatment (adjuvant or palliative treatment, line of therapy), comorbidities, concomitant medications, and previous seasonal influenza vaccination. In March 2009, eligible patients were interviewed to determine if they had contracted influenza (according to the WHO definition: sudden onset of fever >38°, with at least one general symptom such as aching muscles, headache, and malaise and at least one respiratory symptom such as nonproductive cough, sore throat, and rhinitis) and developed a vaccination reaction.

Seventy-two patients, including 38 (52%) females with a median age of 69 years, received vaccination during chemotherapy. Thirty (42%) patients were treated with adjuvant chemotherapy and 42 (58%) for locally advanced or metastatic disease. Twenty-five (35%) patients were treated for gastrointestinal, 17 (24%) for breast, 14 (19%) for urogenital, and 11 (15%) for lung cancers, as well as four for other solid tumors. Eighteen (25%) patients received vaccination for the first time. We found seven (9%) cases of influenza and only three (4%) vaccination reactions (transient muscle soreness, arthralgias, and fever). Considering our results in terms of efficacy and safety, routine vaccination against influenza virus should be considered in patients undergoing chemotherapy.

Our observations have several limitations, represented, in particular, by the absence of a control, nonvaccinated group and of a “true” measure of efficacy vaccination (such as serological response). Nevertheless, the limited sample size, the heterogeneity of the available studies, and the absence of a randomized controlled trial make even an observational study, such as that reported by our institution, valuable.

Fears relating to good pain management include a lack of technical knowledge about pain management and pain assessment. Attitudes about opioid addiction and regulatory guidelines influence the manner in which opioids are prescribed. Patients harbor a variety of fears and misconceptions such as opioid addiction, tolerance, side effects, and the meaning of pain, which can create a barrier to effective communication with health-care providers regarding cancer pain management and specifically BTP. Identifying these issues gives health-care professionals and patients an opportunity to develop strategies that can improve the treatment of BTP.

Many physicians lack the knowledge of proper around-the-clock (ATC) dosing. ATC treatment maintains drug concentrations and prevents peaks and troughs that can increase the risk of toxicity and result in lack of efficacy.

The authors recommend oral transmucosal delivery of opioids as an option for these challenges. Three formulations of the opioid fentanyl are available for transmucosal delivery: oral transmucosal fentanyl citrate (OTFC),⁵ fentanyl buccal tablets (FBTs),⁶ and fentanyl buccal soluble film (FBSF).⁷ OTFC is a fentanyl lozenge that has demonstrated an analgesic effect within 15 minutes of administration. Despite its rapid onset of action, the amount of fentanyl administered with the OTFC lozenge depends on the education provided to the patient on the use of this medication and the ability of the patient to actively use this product.⁵ While FBT (a tablet that utilizes an effervescent reaction to improve absorption) does not require substantial patient participation, its use has been associated with application-site side effects.⁶ Like OTFC and FBT, FBSF offers a rapid onset of action but does not require active patient participation and has minimal oral adverse side effects.⁷ These oral transmucosal fentanyl products should be administered only to opioid-tolerant patients, to avoid the risk of life-threatening respiratory depression. The reviewers stress that these products should be used only in opioid-tolerant patients.

Many physicians are quite aware when they have reached their “comfort level” of working with opioids. It is usually at that point that they will refer patients for consultation to the palliative care team or pain services. Patients may believe that pain is part of the cancer diagnosis and is to be expected. Some patients believe that use of opioids signifies the “end of life” is near. They may believe the side effects related to opioids are unavoidable and the burden of use of opioids outweighs the benefits.⁸

In summary, the article by Rhiner and von Gunten speaks to the challenges that we encounter in treating cancer patients' pain. BTP is often not recognized and at times not adequately treated. This article serves as a good review of the challenges of treating patients with cancer pain and offers suggestions on how to improve the management of cancer pain with our patients.

Fears relating to good pain management include a lack of technical knowledge about pain management and pain assessment. Attitudes about opioid addiction and regulatory guidelines influence the manner in which opioids are prescribed. Patients harbor a variety of fears and misconceptions such as opioid addiction, tolerance, side effects, and the meaning of pain, which can create a barrier to effective communication with health-care providers regarding cancer pain management and specifically BTP. Identifying these issues gives health-care professionals and patients an opportunity to develop strategies that can improve the treatment of BTP.

Many physicians lack the knowledge of proper around-the-clock (ATC) dosing. ATC treatment maintains drug concentrations and prevents peaks and troughs that can increase the risk of toxicity and result in lack of efficacy.

The authors recommend oral transmucosal delivery of opioids as an option for these challenges. Three formulations of the opioid fentanyl are available for transmucosal delivery: oral transmucosal fentanyl citrate (OTFC),⁵ fentanyl buccal tablets (FBTs),⁶ and fentanyl buccal soluble film (FBSF).⁷ OTFC is a fentanyl lozenge that has demonstrated an analgesic effect within 15 minutes of administration. Despite its rapid onset of action, the amount of fentanyl administered with the OTFC lozenge depends on the education provided to the patient on the use of this medication and the ability of the patient to actively use this product.⁵ While FBT (a tablet that utilizes an effervescent reaction to improve absorption) does not require substantial patient participation, its use has been associated with application-site side effects.⁶ Like OTFC and FBT, FBSF offers a rapid onset of action but does not require active patient participation and has minimal oral adverse side effects.⁷ These oral transmucosal fentanyl products should be administered only to opioid-tolerant patients, to avoid the risk of life-threatening respiratory depression. The reviewers stress that these products should be used only in opioid-tolerant patients.

Many physicians are quite aware when they have reached their “comfort level” of working with opioids. It is usually at that point that they will refer patients for consultation to the palliative care team or pain services. Patients may believe that pain is part of the cancer diagnosis and is to be expected. Some patients believe that use of opioids signifies the “end of life” is near. They may believe the side effects related to opioids are unavoidable and the burden of use of opioids outweighs the benefits.⁸

In summary, the article by Rhiner and von Gunten speaks to the challenges that we encounter in treating cancer patients' pain. BTP is often not recognized and at times not adequately treated. This article serves as a good review of the challenges of treating patients with cancer pain and offers suggestions on how to improve the management of cancer pain with our patients.

Fears relating to good pain management include a lack of technical knowledge about pain management and pain assessment. Attitudes about opioid addiction and regulatory guidelines influence the manner in which opioids are prescribed. Patients harbor a variety of fears and misconceptions such as opioid addiction, tolerance, side effects, and the meaning of pain, which can create a barrier to effective communication with health-care providers regarding cancer pain management and specifically BTP. Identifying these issues gives health-care professionals and patients an opportunity to develop strategies that can improve the treatment of BTP.

Many physicians lack the knowledge of proper around-the-clock (ATC) dosing. ATC treatment maintains drug concentrations and prevents peaks and troughs that can increase the risk of toxicity and result in lack of efficacy.

The authors recommend oral transmucosal delivery of opioids as an option for these challenges. Three formulations of the opioid fentanyl are available for transmucosal delivery: oral transmucosal fentanyl citrate (OTFC),⁵ fentanyl buccal tablets (FBTs),⁶ and fentanyl buccal soluble film (FBSF).⁷ OTFC is a fentanyl lozenge that has demonstrated an analgesic effect within 15 minutes of administration. Despite its rapid onset of action, the amount of fentanyl administered with the OTFC lozenge depends on the education provided to the patient on the use of this medication and the ability of the patient to actively use this product.⁵ While FBT (a tablet that utilizes an effervescent reaction to improve absorption) does not require substantial patient participation, its use has been associated with application-site side effects.⁶ Like OTFC and FBT, FBSF offers a rapid onset of action but does not require active patient participation and has minimal oral adverse side effects.⁷ These oral transmucosal fentanyl products should be administered only to opioid-tolerant patients, to avoid the risk of life-threatening respiratory depression. The reviewers stress that these products should be used only in opioid-tolerant patients.

Many physicians are quite aware when they have reached their “comfort level” of working with opioids. It is usually at that point that they will refer patients for consultation to the palliative care team or pain services. Patients may believe that pain is part of the cancer diagnosis and is to be expected. Some patients believe that use of opioids signifies the “end of life” is near. They may believe the side effects related to opioids are unavoidable and the burden of use of opioids outweighs the benefits.⁸

In summary, the article by Rhiner and von Gunten speaks to the challenges that we encounter in treating cancer patients' pain. BTP is often not recognized and at times not adequately treated. This article serves as a good review of the challenges of treating patients with cancer pain and offers suggestions on how to improve the management of cancer pain with our patients.

The preferences of women in this scenario regarding the method of communication and the provider who gives results are unknown. Providers try to balance different priorities: getting the information to the woman quickly,^{[3], [4] and [5]} providing as much information as possible,^{[3], [4], [5], [6] and [7]} having the person who talks to the woman be someone they know and trust,⁸ and giving the information in person rather than on the phone.³ One may not be able to maximize all of the competing variables. If the sole priority is speed, then one would develop a system where the radiologist or nurse calls as soon as the biopsy result comes back; if complete information is most important, having someone from an oncologist's office call about positive results may be best. The problem is that there is a lack of published data on women's preferences, leading different programs to be based on assumptions rather than evidence.

Complicating this problem is that women likely have different preferences when the results are benign versus when they are malignant. To our knowledge, the communication preferences of these two groups of patients have never been compared. With evidence-based data about what women prefer, programs can develop more patient-centered programs to communicate biopsy results.

The goal of this study was to ascertain how women who have had a breast biopsy prefer to receive their test results. We also wanted to determine their satisfaction with the way they did receive their biopsy results at our cancer center and whether satisfaction differed based on patient age, race, or biopsy results. It is hoped that these data will help other programs develop communication policies.

Materials and Methods

Study Setting and Patient Recruitment

This study was based on a telephone survey of all radiologic breast biopsy patients seen at a large urban academic breast center between June 1, 2008, and July 31, 2008. The study was approved by the University of Pittsburgh Institutional Review Board. Study participants were adult females receiving a minimally invasive radiologic breast biopsy who spoke English and had a working phone. All patients fitting the inclusion criteria were approached before their procedure and given the option to participate in the study.

The center performed over 3,500 breast biopsies in 2009. At the center, two nurses gave results to an average of 30 patients a day. In addition to making calls, the nurses are responsible for admitting and discharging patients and work on rotation in order to call patients they have personally met. They make notes in patients' charts about their demeanor and concerns to help them tailor the phone calls to the patients' personalities. When patients leave after the biopsy, the nurses discuss the results call and ask the patients if they would prefer the nurse to call them or if they would like to call the nurse on their own time. No option is available for an in-person results visit except by the physician ordering the biopsy.

Study participants received biopsy results within 4 business days. Information about positive and negative results is communicated in different ways. While all results are faxed to the referring physician, positive results have a cover sheet indicating the urgency of the information. If results are positive or require further surgical biopsy, the nurses call in a room with a closed door and a “do not disturb” sign, to minimize interruptions. Nurses provide information using a standardized script that describes the result and their implications. Patients with a malignant biopsy are given a phone number to make a breast magnetic resonance imaging appointment. They are also told that they need to make a surgical appointment, but the choice of surgeon is left up to the patient and the referring physician. Patients are given time to ask questions and the direct phone number if they wish to speak to the nurse again.

Phone Survey Procedure

Two weeks were allotted between receipt of results and the study interview to allow time for patients to understand their diagnosis and seek follow-up care as necessary. After the 2-week waiting period, a study staff member contacted patients by telephone. Calls were conducted in the order in which patients received their results, and four attempts were made to call each participant, with a message left each time.

Study Survey

The phone survey consisted of four sections: an informational section, which collected data about how the patient received the results; a communication skills section, which assessed patient impressions of the person giving results; an improvement section, which assessed patient views about how to improve the communication of results; and finally, a communication priorities section, which assessed the relative importance of four distinct aspects of communication (Table 1). In addition, patients were asked “What did you like best about how you were told your results?” and “What can we do to make the process of giving results better?” The communication skills and improvement sections were scored on a five-point Likert scale, and the communication priorities section was scored on a rank scale from most to least important. (The survey is available on request.) Demographic information as well as the number of previous biopsies the woman had were also collected.

The preferences of women in this scenario regarding the method of communication and the provider who gives results are unknown. Providers try to balance different priorities: getting the information to the woman quickly,^{[3], [4] and [5]} providing as much information as possible,^{[3], [4], [5], [6] and [7]} having the person who talks to the woman be someone they know and trust,⁸ and giving the information in person rather than on the phone.³ One may not be able to maximize all of the competing variables. If the sole priority is speed, then one would develop a system where the radiologist or nurse calls as soon as the biopsy result comes back; if complete information is most important, having someone from an oncologist's office call about positive results may be best. The problem is that there is a lack of published data on women's preferences, leading different programs to be based on assumptions rather than evidence.

Complicating this problem is that women likely have different preferences when the results are benign versus when they are malignant. To our knowledge, the communication preferences of these two groups of patients have never been compared. With evidence-based data about what women prefer, programs can develop more patient-centered programs to communicate biopsy results.

The goal of this study was to ascertain how women who have had a breast biopsy prefer to receive their test results. We also wanted to determine their satisfaction with the way they did receive their biopsy results at our cancer center and whether satisfaction differed based on patient age, race, or biopsy results. It is hoped that these data will help other programs develop communication policies.

Materials and Methods

Study Setting and Patient Recruitment

This study was based on a telephone survey of all radiologic breast biopsy patients seen at a large urban academic breast center between June 1, 2008, and July 31, 2008. The study was approved by the University of Pittsburgh Institutional Review Board. Study participants were adult females receiving a minimally invasive radiologic breast biopsy who spoke English and had a working phone. All patients fitting the inclusion criteria were approached before their procedure and given the option to participate in the study.

The center performed over 3,500 breast biopsies in 2009. At the center, two nurses gave results to an average of 30 patients a day. In addition to making calls, the nurses are responsible for admitting and discharging patients and work on rotation in order to call patients they have personally met. They make notes in patients' charts about their demeanor and concerns to help them tailor the phone calls to the patients' personalities. When patients leave after the biopsy, the nurses discuss the results call and ask the patients if they would prefer the nurse to call them or if they would like to call the nurse on their own time. No option is available for an in-person results visit except by the physician ordering the biopsy.

Study participants received biopsy results within 4 business days. Information about positive and negative results is communicated in different ways. While all results are faxed to the referring physician, positive results have a cover sheet indicating the urgency of the information. If results are positive or require further surgical biopsy, the nurses call in a room with a closed door and a “do not disturb” sign, to minimize interruptions. Nurses provide information using a standardized script that describes the result and their implications. Patients with a malignant biopsy are given a phone number to make a breast magnetic resonance imaging appointment. They are also told that they need to make a surgical appointment, but the choice of surgeon is left up to the patient and the referring physician. Patients are given time to ask questions and the direct phone number if they wish to speak to the nurse again.

Phone Survey Procedure

Two weeks were allotted between receipt of results and the study interview to allow time for patients to understand their diagnosis and seek follow-up care as necessary. After the 2-week waiting period, a study staff member contacted patients by telephone. Calls were conducted in the order in which patients received their results, and four attempts were made to call each participant, with a message left each time.

Study Survey

The phone survey consisted of four sections: an informational section, which collected data about how the patient received the results; a communication skills section, which assessed patient impressions of the person giving results; an improvement section, which assessed patient views about how to improve the communication of results; and finally, a communication priorities section, which assessed the relative importance of four distinct aspects of communication (Table 1). In addition, patients were asked “What did you like best about how you were told your results?” and “What can we do to make the process of giving results better?” The communication skills and improvement sections were scored on a five-point Likert scale, and the communication priorities section was scored on a rank scale from most to least important. (The survey is available on request.) Demographic information as well as the number of previous biopsies the woman had were also collected.

The preferences of women in this scenario regarding the method of communication and the provider who gives results are unknown. Providers try to balance different priorities: getting the information to the woman quickly,^{[3], [4] and [5]} providing as much information as possible,^{[3], [4], [5], [6] and [7]} having the person who talks to the woman be someone they know and trust,⁸ and giving the information in person rather than on the phone.³ One may not be able to maximize all of the competing variables. If the sole priority is speed, then one would develop a system where the radiologist or nurse calls as soon as the biopsy result comes back; if complete information is most important, having someone from an oncologist's office call about positive results may be best. The problem is that there is a lack of published data on women's preferences, leading different programs to be based on assumptions rather than evidence.

Complicating this problem is that women likely have different preferences when the results are benign versus when they are malignant. To our knowledge, the communication preferences of these two groups of patients have never been compared. With evidence-based data about what women prefer, programs can develop more patient-centered programs to communicate biopsy results.

The goal of this study was to ascertain how women who have had a breast biopsy prefer to receive their test results. We also wanted to determine their satisfaction with the way they did receive their biopsy results at our cancer center and whether satisfaction differed based on patient age, race, or biopsy results. It is hoped that these data will help other programs develop communication policies.

Materials and Methods

Study Setting and Patient Recruitment

This study was based on a telephone survey of all radiologic breast biopsy patients seen at a large urban academic breast center between June 1, 2008, and July 31, 2008. The study was approved by the University of Pittsburgh Institutional Review Board. Study participants were adult females receiving a minimally invasive radiologic breast biopsy who spoke English and had a working phone. All patients fitting the inclusion criteria were approached before their procedure and given the option to participate in the study.

The center performed over 3,500 breast biopsies in 2009. At the center, two nurses gave results to an average of 30 patients a day. In addition to making calls, the nurses are responsible for admitting and discharging patients and work on rotation in order to call patients they have personally met. They make notes in patients' charts about their demeanor and concerns to help them tailor the phone calls to the patients' personalities. When patients leave after the biopsy, the nurses discuss the results call and ask the patients if they would prefer the nurse to call them or if they would like to call the nurse on their own time. No option is available for an in-person results visit except by the physician ordering the biopsy.

Study participants received biopsy results within 4 business days. Information about positive and negative results is communicated in different ways. While all results are faxed to the referring physician, positive results have a cover sheet indicating the urgency of the information. If results are positive or require further surgical biopsy, the nurses call in a room with a closed door and a “do not disturb” sign, to minimize interruptions. Nurses provide information using a standardized script that describes the result and their implications. Patients with a malignant biopsy are given a phone number to make a breast magnetic resonance imaging appointment. They are also told that they need to make a surgical appointment, but the choice of surgeon is left up to the patient and the referring physician. Patients are given time to ask questions and the direct phone number if they wish to speak to the nurse again.

Phone Survey Procedure

Two weeks were allotted between receipt of results and the study interview to allow time for patients to understand their diagnosis and seek follow-up care as necessary. After the 2-week waiting period, a study staff member contacted patients by telephone. Calls were conducted in the order in which patients received their results, and four attempts were made to call each participant, with a message left each time.

Study Survey

The phone survey consisted of four sections: an informational section, which collected data about how the patient received the results; a communication skills section, which assessed patient impressions of the person giving results; an improvement section, which assessed patient views about how to improve the communication of results; and finally, a communication priorities section, which assessed the relative importance of four distinct aspects of communication (Table 1). In addition, patients were asked “What did you like best about how you were told your results?” and “What can we do to make the process of giving results better?” The communication skills and improvement sections were scored on a five-point Likert scale, and the communication priorities section was scored on a rank scale from most to least important. (The survey is available on request.) Demographic information as well as the number of previous biopsies the woman had were also collected.