Support Care Cancer (2015) 23:317–324 DOI 10.1007/s00520-014-2361-6
ORIGINAL ARTICLE
Expectations from an integrative medicine consultation in breast cancer care: a registry protocol-based study Noah Samuels & Elad Schiff & Ofer Lavie & Orit Gressel Raz & Eran Ben-Arye
Received: 17 March 2014 / Accepted: 21 July 2014 / Published online: 30 July 2014 # Springer-Verlag Berlin Heidelberg 2014
Abstract Purpose The purpose of this study is to compare the rationale given by oncology health care practitioners (HCPs) for referral of their patients with breast cancer to a complementary medicine (CM) consultation with patient expectations from the CM treatment process. Methods We conducted a prospective, registry protocolbased, open-label study. We compared the indications given by oncology HCPs for their referral of patients to the CM consultation with patient expectations from the CM
N. Samuels : O. G. Raz : E. Ben-Arye Integrative Oncology Program, Oncology Service, Lin Medical Center Clalit Health Services, Haifa and Western Galilee District, Israel N. Samuels (*) Tal Center for Integrative Medicine, Institute of Oncology, Sheba Medical Center, Tel Hashomer 52621, Israel e-mail: [email protected] E. Schiff Department of Internal Medicine and Integrative Surgery Service, Bnai Zion Hospital, Haifa, Israel E. Schiff The International Center for Health, Law, and Ethics, Haifa, Israel O. Lavie Department of Obstetrics and Gynecology, Gynecologic Oncology Service, Carmel Medical Center, Haifa, Israel O. G. Raz Clalit Complementary Medicine, Clalit Health Services, Haifa, Israel E. Ben-Arye Complementary and Traditional Medicine Unit, Department of Family Medicine, Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel and Clalit Health Services, Haifa and Western Galilee District, Israel
therapeutic process. Patients were asked regarding prior CM use for cancer- and non-cancer-related indications. Results A total of 127 patients referred to the CM consultation were studied, with half reporting prior CM use. The most popular treatment for non-cancer-related indications was acupuncture (46.9 %), with only 20.3 % reporting herbal medicine use (P≤0.04). For cancer-related indications, herbal medicine was the most popular modality (42.4 %), with 11.6 % reporting acupuncture use. The most frequently cited indications for referral were general symptom reduction (19.7 %), emotional/spiritual relief (18.1 %), alleviation of weakness and fatigue (17.3 %), and reduction of gastrointestinal symptoms (10.2 %). For patients, the most important outcome was alleviation of weakness and fatigue (70.4 %), followed by emotional/spiritual relief (50 %), and the reduction of gastrointestinal symptoms (33.3 %). The correlation between HCP indications for referral and patient expectations was poor (Cohen’s kappa of 0.19, 0.328, and 0.20, respectively). Conclusions The findings suggest that expectations from a CM treatment process differ greatly between oncology HCPs and patients with breast cancer. The use of a structured clinical referral process and a better understanding of patient concerns are factors which play a central role in the CM referral process. Keywords Integrative medicine . Breast cancer . Doctor-patient communication . Quality of life . Complementary medicine
Introduction The use of complementary medicine (CM) is prevalent among patients with breast cancer, with approximately half of patients using at least one CM modality [1]. Patients diagnosed with breast cancer, as well as those at risk, have also shown high rates of CM use [2,3]. CM therapies can range from the use of
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dietary supplements to acupuncture, manual modalities, and mind-body therapies [4,5]. Many patients use CM in addition to their conventional anti-cancer care [4]. A nationwide study in Denmark found that 40 % of patients with early-stage breast cancer were using CM in conjunction with conventional chemotherapy [6]. Significantly high rates of CM use have also been reported by patients during radiotherapy [7]. The use of CM is associated with a lower self-assessment of quality of life (QOL), higher education, and younger age [8,9]. Patients turn to complementary medicine in order to reduce physical symptoms, psychological distress, and chemotheraphy/ radiotherapy side effects [10]; obtain a feeling of control over the treatment process [11]; strengthen their body’s immune system [12]; and finally, increase rates of cure [13]. There is a large body of evidence supporting the role of CM for the improvement of QOL-related outcomes in patients with breast cancer. Acupuncture has been shown to reduce cancer-related fatigue [14], vasomotor symptoms [15–17], insomnia [18], aromatase inhibitor-associated arthralgia [19], and chemotherapy-induced emesis [20]. Other CM therapies such as relaxation techniques, mind-body medicine, yoga, and behavioral therapies have been found to be effective in reducing psycho-social distress [21–23], improving the quality of sleep [24] and reducing menopausal symptoms [25]. Reflexology and massage have been shown to reduce both emotional distress [26], as well as cancer-related fatigue [27]. Botanical compounds such as Viscum album (mistletoe) have been shown to improve physical, emotional, and functional well-being in patients with breast cancer [28] and ginger to reduce chemotherapy-induced nausea [29]. While CM may help improve QOL-related outcomes, potentially negative effects need to be considered as well. Interactions between dietary supplements and conventional anti-cancer therapies, for example, are believed by some to compromise treatment outcomes and increase toxicity [30]. An example of this is the popular herb St. John’s wort (Hypericum perforatum), commonly used for depressive disorders, whose active component hyperforin has been shown to induce docetaxel metabolism, reducing serum levels and activity of the drug [31]. The herb Ginkgo biloba significantly elevates serum levels of paclitaxel and increases the drug’s toxicity [32]. However, the potential for such interactions and their effect on therapeutic outcomes are still unclear [33]. The term “complementary medicine” has, in recent years, undergone a transformation in which it is being replaced by the term “integrative medicine.” This change is not only semantic but rather one of substance. The term integrative medicine reflects the incorporation of evidence-based CM practices within the conventional medical setting, offering a patient-centered and holistic framework for the promotion of well-being [34]. The National Quality Forum has stated that “there is strong evidence that integrative care can heal and improve basic conventional care by addressing the mind, body and spirit
Support Care Cancer (2015) 23:317–324
connection” [35]. As a result of the increased awareness, a number of leading cancer centers in North America have established integrative medicine programs [36,37]. In 2007, the Haifa and Western Galilee District of the Clalit Health Service (CHS) set out to test the feasibility of integrating CM within the Clalit Oncology Service (COS) [38]. The CHS is the largest health maintenance organization in Israel, serving over 4 million clients nationally. In 2008, the CHS established the Integrative Oncology Program (IOP), with the goal of addressing patient concerns and improving QOL parameters during chemotherapy and advanced disease. Oncology health care providers (HCPs) working with the integrative program refer patients to the IOP for a CM consultation, which is conducted by an integrative physician (IP). The purpose of the present study was to compare the rationale given by oncology HCPs for their referral of patients to the CM consultation with expectations of patients from the CM consultation and treatments. Characteristics of prior CM use by patients for cancer-related and non-cancer-related indications were examined as well. The implications of integrating CM therapies within a conventional oncology setting are discussed.
Methods Study sites and participants The study took place between July 2009 and August 2012 at two COS centers located in Haifa in northern Israel. The study centers provide outpatient treatments to more than 1,000 oncology patients each year and work in conjunction with hospital-based oncology departments. Female patients aged 18 years and older with a diagnosis of breast cancer were eligible for inclusion in the study. Study design The present research was a prospective, registry protocolbased open-label study. Patients presenting to either of the COS centers for chemotherapy or those who had begun chemotherapy for either local (in adjuvant or neo-adjuvant settings) or active disease (in curative or palliative settings) were referred to the study IOP by one of the study HCPs. Referral to a CM consultation at the IOP is based on a list of predesignated clinical indications which include one or more of the following: fatigue, gastrointestinal symptoms, pain or neuropathic symptoms (e.g., chemotherapy-induced neuropathy), emotional or spiritual concerns, hematological toxicities, dyspnea, gynecology-urinary symptoms, or other QOL concerns (Appendix 1). However, HCPs who wish to explain their indications for referral in free text are encouraged to do so. HCPs generate the referral via a structured letter addressed directly to the study center’s IP.
Support Care Cancer (2015) 23:317–324
The CM consultation provided by the IP is considered an integral component of the COS supportive care service. Upon presentation to the IOP, an integrative medical intake interview is conducted by one of the study IPs. Integrative physicians are conventional (MD) physicians with extensive training in CM (such as an integrative medicine fellowship), with competence in two or more CM treatment modalities (herbal medicine, traditional Chinese medicine, Anthroposophic medicine, mind-body medicine, etc.) as well as in supportive cancer care. During the first intake interview the IP and patient discuss a number of biopsycho-social issues related to the cancer diagnosis and treatment, including coping with other medical conditions. The consultation lasts approximately 1 hour, during which the IP also addresses a number of issues, such as patient’s expectations regarding CM; previous experience with traditional, alternative, or CM; and finally, the patient’s narrative and outlook regarding diagnosis, treatment, coping, and well-being.
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reliability of the correlation between HCP indications for referral of patients to the CM consultation and patient expectations from the CM therapeutic process was measured using a Cohen’s kappa coefficient. A P value of less than 0.05 was considered to be statistically significant. Ethical considerations Participation in the study was voluntary, for both patients and HCPs at the COS. Informed consent was provided by participants, and the study protocol was approved by the Ethics (Helsinki) committee of the Carmel Medical Center, Haifa, Israel.
Results Study population
Outcome measures The primary outcome measure examined in the present study was to compare the rationale for oncology HCP referral of patients with breast cancer to a CM consultation, based on their indications for the referral, and patient’s expectation from the CM treatment process. Secondary outcome measures included the reported rates of CM use by patients prior to the study, examining whether CM was used for cancer-related or non-cancer-related outcomes. For this purpose, CM was defined as “therapies often named alternative, complementary, integrative, natural, or folk/traditional medicine” [38]. A list of 12 CM modalities commonly used in Israel was included for this purpose. Cancer-related CM use was defined as any CM modality, technique, or dietary supplement which had been used by patients following their cancer diagnosis, or else being used for the treatment of toxic effects of anti-cancer treatments or for the relief of symptoms and QOL-related parameters. Other indications were considered to be non-cancer-related.
During the study period, the participating oncology HCPs referred 155 patients with breast cancer for CM consultation. Of these, 127 patients were seen by the study IP (81.9 %). Of the remaining patients, 19 had scheduled an appointment with the study IP but were unable to show, mainly due to clinical deterioration; 3 postponed their initial appointment and did not make any further contact; 1 was not interested in an integrative medicine consultation; and 5 could not be located. The demographic and oncology-related characteristics of the study group are presented in Table 1. The mean age of the patients was nearly 60 years of age, with just over half of respondents born in Israel. The location of residence for respondents was divided in an even fashion. More than two thirds of patients had non-metastatic disease, and less than a quarter were with recurrent disease. More than half of patients were currently undergoing adjuvant chemotherapy regimens, and most had already received between three and four treatment cycles upon presentation to the study center.
Data analysis
Reported use of complementary medicine
Data were collated using an Excel spreadsheet (Microsoft 2010) and analyzed using the SPSS software program (version 18; SPSS Inc., Chicago, IL). HCP indications for referral (based on either the list provided or else a free-text response) and patient expectations (expressed during the initial IP consultation) were coded and entered into the database for analysis. Variations in the prevalence of categorical variables and demographic data were evaluated using a Pearson’s chisquared test and Fisher’s exact test. In order to detect differences between the continuous variables (when normality was assumed), a t test was performed. A Mann-Whitney U test was used in cases of non-normal distribution. The inter-rater
Nearly half of patients reported using CM prior to study induction, for either non-cancer-related indications, cancerrelated indications, or both (Table 2). The most popular treatment modality reportedly used by patients for non-cancerrelated indications was acupuncture, followed by manual modalities and then the use of herbal medicine. In contrast, the most popular treatment modality reportedly for cancer-related indications was herbal medicine, followed by dietary advice and the use of nutritional supplements. Only an eighth of patients reported using acupuncture for this group of indications. The difference in CM use between those who had used CM in the past for non-cancer-related indications and those
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Support Care Cancer (2015) 23:317–324
Table 1 Characteristics of patients with breast cancer referred to a CM consultation (n=127) Demographic Mean age ± SD (years) Country of birth Israel Other Main spoken language Hebrew Russian Arabic Location of residencea Local Suburbs Periphery Oncological Evidence of cancer spread Metastases Non-metastatic Evidence of cancer recurrence Recurrent Non-recurrent Chemotherapy regimen Neo-adjuvant Adjuvant Palliative No. of treatment cycles
ORIGINAL ARTICLE
Expectations from an integrative medicine consultation in breast cancer care: a registry protocol-based study Noah Samuels & Elad Schiff & Ofer Lavie & Orit Gressel Raz & Eran Ben-Arye
Received: 17 March 2014 / Accepted: 21 July 2014 / Published online: 30 July 2014 # Springer-Verlag Berlin Heidelberg 2014
Abstract Purpose The purpose of this study is to compare the rationale given by oncology health care practitioners (HCPs) for referral of their patients with breast cancer to a complementary medicine (CM) consultation with patient expectations from the CM treatment process. Methods We conducted a prospective, registry protocolbased, open-label study. We compared the indications given by oncology HCPs for their referral of patients to the CM consultation with patient expectations from the CM
N. Samuels : O. G. Raz : E. Ben-Arye Integrative Oncology Program, Oncology Service, Lin Medical Center Clalit Health Services, Haifa and Western Galilee District, Israel N. Samuels (*) Tal Center for Integrative Medicine, Institute of Oncology, Sheba Medical Center, Tel Hashomer 52621, Israel e-mail: [email protected] E. Schiff Department of Internal Medicine and Integrative Surgery Service, Bnai Zion Hospital, Haifa, Israel E. Schiff The International Center for Health, Law, and Ethics, Haifa, Israel O. Lavie Department of Obstetrics and Gynecology, Gynecologic Oncology Service, Carmel Medical Center, Haifa, Israel O. G. Raz Clalit Complementary Medicine, Clalit Health Services, Haifa, Israel E. Ben-Arye Complementary and Traditional Medicine Unit, Department of Family Medicine, Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel and Clalit Health Services, Haifa and Western Galilee District, Israel
therapeutic process. Patients were asked regarding prior CM use for cancer- and non-cancer-related indications. Results A total of 127 patients referred to the CM consultation were studied, with half reporting prior CM use. The most popular treatment for non-cancer-related indications was acupuncture (46.9 %), with only 20.3 % reporting herbal medicine use (P≤0.04). For cancer-related indications, herbal medicine was the most popular modality (42.4 %), with 11.6 % reporting acupuncture use. The most frequently cited indications for referral were general symptom reduction (19.7 %), emotional/spiritual relief (18.1 %), alleviation of weakness and fatigue (17.3 %), and reduction of gastrointestinal symptoms (10.2 %). For patients, the most important outcome was alleviation of weakness and fatigue (70.4 %), followed by emotional/spiritual relief (50 %), and the reduction of gastrointestinal symptoms (33.3 %). The correlation between HCP indications for referral and patient expectations was poor (Cohen’s kappa of 0.19, 0.328, and 0.20, respectively). Conclusions The findings suggest that expectations from a CM treatment process differ greatly between oncology HCPs and patients with breast cancer. The use of a structured clinical referral process and a better understanding of patient concerns are factors which play a central role in the CM referral process. Keywords Integrative medicine . Breast cancer . Doctor-patient communication . Quality of life . Complementary medicine
Introduction The use of complementary medicine (CM) is prevalent among patients with breast cancer, with approximately half of patients using at least one CM modality [1]. Patients diagnosed with breast cancer, as well as those at risk, have also shown high rates of CM use [2,3]. CM therapies can range from the use of
318
dietary supplements to acupuncture, manual modalities, and mind-body therapies [4,5]. Many patients use CM in addition to their conventional anti-cancer care [4]. A nationwide study in Denmark found that 40 % of patients with early-stage breast cancer were using CM in conjunction with conventional chemotherapy [6]. Significantly high rates of CM use have also been reported by patients during radiotherapy [7]. The use of CM is associated with a lower self-assessment of quality of life (QOL), higher education, and younger age [8,9]. Patients turn to complementary medicine in order to reduce physical symptoms, psychological distress, and chemotheraphy/ radiotherapy side effects [10]; obtain a feeling of control over the treatment process [11]; strengthen their body’s immune system [12]; and finally, increase rates of cure [13]. There is a large body of evidence supporting the role of CM for the improvement of QOL-related outcomes in patients with breast cancer. Acupuncture has been shown to reduce cancer-related fatigue [14], vasomotor symptoms [15–17], insomnia [18], aromatase inhibitor-associated arthralgia [19], and chemotherapy-induced emesis [20]. Other CM therapies such as relaxation techniques, mind-body medicine, yoga, and behavioral therapies have been found to be effective in reducing psycho-social distress [21–23], improving the quality of sleep [24] and reducing menopausal symptoms [25]. Reflexology and massage have been shown to reduce both emotional distress [26], as well as cancer-related fatigue [27]. Botanical compounds such as Viscum album (mistletoe) have been shown to improve physical, emotional, and functional well-being in patients with breast cancer [28] and ginger to reduce chemotherapy-induced nausea [29]. While CM may help improve QOL-related outcomes, potentially negative effects need to be considered as well. Interactions between dietary supplements and conventional anti-cancer therapies, for example, are believed by some to compromise treatment outcomes and increase toxicity [30]. An example of this is the popular herb St. John’s wort (Hypericum perforatum), commonly used for depressive disorders, whose active component hyperforin has been shown to induce docetaxel metabolism, reducing serum levels and activity of the drug [31]. The herb Ginkgo biloba significantly elevates serum levels of paclitaxel and increases the drug’s toxicity [32]. However, the potential for such interactions and their effect on therapeutic outcomes are still unclear [33]. The term “complementary medicine” has, in recent years, undergone a transformation in which it is being replaced by the term “integrative medicine.” This change is not only semantic but rather one of substance. The term integrative medicine reflects the incorporation of evidence-based CM practices within the conventional medical setting, offering a patient-centered and holistic framework for the promotion of well-being [34]. The National Quality Forum has stated that “there is strong evidence that integrative care can heal and improve basic conventional care by addressing the mind, body and spirit
Support Care Cancer (2015) 23:317–324
connection” [35]. As a result of the increased awareness, a number of leading cancer centers in North America have established integrative medicine programs [36,37]. In 2007, the Haifa and Western Galilee District of the Clalit Health Service (CHS) set out to test the feasibility of integrating CM within the Clalit Oncology Service (COS) [38]. The CHS is the largest health maintenance organization in Israel, serving over 4 million clients nationally. In 2008, the CHS established the Integrative Oncology Program (IOP), with the goal of addressing patient concerns and improving QOL parameters during chemotherapy and advanced disease. Oncology health care providers (HCPs) working with the integrative program refer patients to the IOP for a CM consultation, which is conducted by an integrative physician (IP). The purpose of the present study was to compare the rationale given by oncology HCPs for their referral of patients to the CM consultation with expectations of patients from the CM consultation and treatments. Characteristics of prior CM use by patients for cancer-related and non-cancer-related indications were examined as well. The implications of integrating CM therapies within a conventional oncology setting are discussed.
Methods Study sites and participants The study took place between July 2009 and August 2012 at two COS centers located in Haifa in northern Israel. The study centers provide outpatient treatments to more than 1,000 oncology patients each year and work in conjunction with hospital-based oncology departments. Female patients aged 18 years and older with a diagnosis of breast cancer were eligible for inclusion in the study. Study design The present research was a prospective, registry protocolbased open-label study. Patients presenting to either of the COS centers for chemotherapy or those who had begun chemotherapy for either local (in adjuvant or neo-adjuvant settings) or active disease (in curative or palliative settings) were referred to the study IOP by one of the study HCPs. Referral to a CM consultation at the IOP is based on a list of predesignated clinical indications which include one or more of the following: fatigue, gastrointestinal symptoms, pain or neuropathic symptoms (e.g., chemotherapy-induced neuropathy), emotional or spiritual concerns, hematological toxicities, dyspnea, gynecology-urinary symptoms, or other QOL concerns (Appendix 1). However, HCPs who wish to explain their indications for referral in free text are encouraged to do so. HCPs generate the referral via a structured letter addressed directly to the study center’s IP.
Support Care Cancer (2015) 23:317–324
The CM consultation provided by the IP is considered an integral component of the COS supportive care service. Upon presentation to the IOP, an integrative medical intake interview is conducted by one of the study IPs. Integrative physicians are conventional (MD) physicians with extensive training in CM (such as an integrative medicine fellowship), with competence in two or more CM treatment modalities (herbal medicine, traditional Chinese medicine, Anthroposophic medicine, mind-body medicine, etc.) as well as in supportive cancer care. During the first intake interview the IP and patient discuss a number of biopsycho-social issues related to the cancer diagnosis and treatment, including coping with other medical conditions. The consultation lasts approximately 1 hour, during which the IP also addresses a number of issues, such as patient’s expectations regarding CM; previous experience with traditional, alternative, or CM; and finally, the patient’s narrative and outlook regarding diagnosis, treatment, coping, and well-being.
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reliability of the correlation between HCP indications for referral of patients to the CM consultation and patient expectations from the CM therapeutic process was measured using a Cohen’s kappa coefficient. A P value of less than 0.05 was considered to be statistically significant. Ethical considerations Participation in the study was voluntary, for both patients and HCPs at the COS. Informed consent was provided by participants, and the study protocol was approved by the Ethics (Helsinki) committee of the Carmel Medical Center, Haifa, Israel.
Results Study population
Outcome measures The primary outcome measure examined in the present study was to compare the rationale for oncology HCP referral of patients with breast cancer to a CM consultation, based on their indications for the referral, and patient’s expectation from the CM treatment process. Secondary outcome measures included the reported rates of CM use by patients prior to the study, examining whether CM was used for cancer-related or non-cancer-related outcomes. For this purpose, CM was defined as “therapies often named alternative, complementary, integrative, natural, or folk/traditional medicine” [38]. A list of 12 CM modalities commonly used in Israel was included for this purpose. Cancer-related CM use was defined as any CM modality, technique, or dietary supplement which had been used by patients following their cancer diagnosis, or else being used for the treatment of toxic effects of anti-cancer treatments or for the relief of symptoms and QOL-related parameters. Other indications were considered to be non-cancer-related.
During the study period, the participating oncology HCPs referred 155 patients with breast cancer for CM consultation. Of these, 127 patients were seen by the study IP (81.9 %). Of the remaining patients, 19 had scheduled an appointment with the study IP but were unable to show, mainly due to clinical deterioration; 3 postponed their initial appointment and did not make any further contact; 1 was not interested in an integrative medicine consultation; and 5 could not be located. The demographic and oncology-related characteristics of the study group are presented in Table 1. The mean age of the patients was nearly 60 years of age, with just over half of respondents born in Israel. The location of residence for respondents was divided in an even fashion. More than two thirds of patients had non-metastatic disease, and less than a quarter were with recurrent disease. More than half of patients were currently undergoing adjuvant chemotherapy regimens, and most had already received between three and four treatment cycles upon presentation to the study center.
Data analysis
Reported use of complementary medicine
Data were collated using an Excel spreadsheet (Microsoft 2010) and analyzed using the SPSS software program (version 18; SPSS Inc., Chicago, IL). HCP indications for referral (based on either the list provided or else a free-text response) and patient expectations (expressed during the initial IP consultation) were coded and entered into the database for analysis. Variations in the prevalence of categorical variables and demographic data were evaluated using a Pearson’s chisquared test and Fisher’s exact test. In order to detect differences between the continuous variables (when normality was assumed), a t test was performed. A Mann-Whitney U test was used in cases of non-normal distribution. The inter-rater
Nearly half of patients reported using CM prior to study induction, for either non-cancer-related indications, cancerrelated indications, or both (Table 2). The most popular treatment modality reportedly used by patients for non-cancerrelated indications was acupuncture, followed by manual modalities and then the use of herbal medicine. In contrast, the most popular treatment modality reportedly for cancer-related indications was herbal medicine, followed by dietary advice and the use of nutritional supplements. Only an eighth of patients reported using acupuncture for this group of indications. The difference in CM use between those who had used CM in the past for non-cancer-related indications and those
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Support Care Cancer (2015) 23:317–324
Table 1 Characteristics of patients with breast cancer referred to a CM consultation (n=127) Demographic Mean age ± SD (years) Country of birth Israel Other Main spoken language Hebrew Russian Arabic Location of residencea Local Suburbs Periphery Oncological Evidence of cancer spread Metastases Non-metastatic Evidence of cancer recurrence Recurrent Non-recurrent Chemotherapy regimen Neo-adjuvant Adjuvant Palliative No. of treatment cycles
