Measuring Concerns of Cancer Patients Referred to Complementary Medicine Treatment Integrated Within Oncology Service

Study Overview
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Brief Summary
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In 2007, the Haifa and Western Galilee district of the CHS set out to test the feasibility of integrating complementary medicine (CM) within the CHS Oncology Service. In 2008, the CHS established the Integrative Oncology Program with the goal of addressing patient concerns and improving quality of life parameters during chemotherapy and advanced disease. The study hypothesis is that integrated medicine consultation and treatment provided within the oncology department may improve patients' concerns and well-being.

Detailed Description
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In 2007, the Haifa and Western Galilee district of the CHS set out to test the feasibility of integrating complementary medicine (CM) within the CHS Oncology Service. In 2008, the CHS established the Integrative Oncology Program with the goal of addressing patient concerns and improving quality of life parameters during chemotherapy and advanced disease. The study is purposed to assess concerns, needs and perspectives of patients referred to integrative consultation during chemotherapy and/or advanced cancer; to characterize social demographic and health parameters of patients who consult or avoid integrative medicine consultation; to document complementary medicine use prior and during consultation; to assess if complementary medicine consultation and treatment improve patient's concerns and well-being; and to assess oncology provider and integrative practitioner communications issues concerning integrative care.

Official Title
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Measuring Concerns and Needs of Cancer Patients Referred to Complementary Medicine Treatment Integrated Within the Oncology Service

Conditions
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Quality of Life

Intervention / Treatment
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* Other: Complementary medicine consultation and treatment
* Other: Patients receiving conventional supportive care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with cancer diagnosis receiving chemotherapy and/or surgical treatment who are referred by their oncology provider to complementary medicine consultation Age older than 18 years Exclusion Criteria: Age younger than 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Complementary medicine counseling<br>Patients receiving chemotherapy who are referred by their oncology provider to complementary medicine consultation and treatment provided in addition to conventional supportive care | Other: Complementary medicine consultation and treatment<br>* Patients receiving chemotherapy will be referred by their oncology provider to complementary medicine (CM) consultation and treatment provided in addition to conventional supportive care.CM consultation will include assessment of patients' concerns and well-being, current CM use (including herbal and nutritional supplements), and construction of CM treatment based on efficacy and safety considerations.<br>|
| Active Comparator: Conventional supportive care<br>Patients receiving conventional supportive care | Other: Patients receiving conventional supportive care<br>* Patients receiving chemotherapy will be offered assessment of their concerns and well-being as well as their current complementary medicine (CM) use (including herbal and nutritional supplements). Patients in this arm study will receive conventional supportive care with no added CM consultation or treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MYCAW (Measure Yourself Concerns and Wellbeing)questionnaire | Assessing patients'concerns and Wellbeing as well as narrative assessment of integrative care outcomes | 6-12 weeks(+follow-up 4 months) | 
| ESAS (Edmonton Symptom Assessment Scale)questionnaire | Assessing the severity of 10 leading symptoms and well-being | 6-12 weeks(+follow-up 4 months) | 
| EORTC QLQ-C30 | The EORTC quality of life questionnaire (QLQ) is an integrated system for assessing the health related quality of life of cancer patients. The questionnaire includes functional and symptom scales. | 6-12 weeks(+follow-up 4 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FACIT-Sp-12 questionnaire | Assessing patients' spiritual well-being | 2-4 months | 
| Attitudes concerning complementary medicine | Assessment of patients' attitudes concerning complementary medicine (CM)safety and efficacy, health beliefs concerning mind-body interactions, and willingness to receive CM treatments | 6-12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of life, Integrative medicine, Supportive care, Cancer, Chemotherapy