Clinical trial NCT01860365: Measuring Concerns of Cancer Patients Referred to Complementary Medicine Treatment Integrated Within Oncology Service
Official title: Measuring Concerns and Needs of Cancer Patients Referred to Complementary Medicine Treatment Integrated Within the Oncology Service
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Quality of Life
Keywords: Quality of life
Integrative medicine
Supportive care
Cancer
Chemotherapy
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2013-05-22
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: MYCAW (Measure Yourself Concerns and Wellbeing)questionnaire
timeFrame: 6-12 weeks(+follow-up 4 months)
measure: ESAS (Edmonton Symptom Assessment Scale)questionnaire
timeFrame: 6-12 weeks(+follow-up 4 months)
measure: EORTC QLQ-C30
timeFrame: 6-12 weeks(+follow-up 4 months)
Secondary outcomes:
measure: FACIT-Sp-12 questionnaire
timeFrame: 2-4 months
measure: Attitudes concerning complementary medicine
timeFrame: 6-12 weeks
Other outcomes:
measure: Complementary medicine side-effects documentation
timeFrame: 6-12 weeks(+follow-up 4 months)
Locations:
city: Haifa
country: Israel
facility: Lin Zebulon and Carmel Medical centers
Study officials:
affiliation: Clalit Health Services
name: Eran Ben-Arye, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ben-Arye E, Elly M, Gressel O, Reshef A, Shani Md M, Stein N, Saliba W, Samuels N. Exploring the effectiveness of a patient-tailored integrative oncology program on emotional distress during chemotherapy for localized cancer. Psychooncology. 2022 Feb;31(2):207-218. doi: 10.1002/pon.5794. Epub 2021 Aug 26.
citation: Kerner H, Samuels N, Ben Moshe S, Sharabi IS, Ben-Arye E. Impact of a patient-tailored complementary/integrative medicine programme on disturbed sleep quality among patients undergoing chemotherapy. BMJ Support Palliat Care. 2020 Sep;10(3):e21. doi: 10.1136/bmjspcare-2017-001351. Epub 2017 Jul 14.
citation: Sharabi IS, Levin A, Schiff E, Samuels N, Agour O, Tapiro Y, Lev E, Keinan-Boker L, Ben-Arye E. Quality of life-related outcomes from a patient-tailored integrative medicine program: experience of Russian-speaking patients with cancer in Israel. Support Care Cancer. 2016 Oct;24(10):4345-55. doi: 10.1007/s00520-016-3274-3. Epub 2016 May 11.
citation: Ben-Arye E, Keshet Y, Shahbar IM, Aharonson ML, Preis L, Agour O, Schiff E, Samuels N. The kitchen as therapy: qualitative assessment of an integrative cuisine workshop for patients undergoing chemotherapy. Support Care Cancer. 2016 Apr;24(4):1487-95. doi: 10.1007/s00520-015-2934-z. Epub 2015 Sep 11.
citation: Ben-Arye E, Samuels N, Schiff E, Raz OG, Sharabi IS, Lavie O. Quality-of-life outcomes in patients with gynecologic cancer referred to integrative oncology treatment during chemotherapy. Support Care Cancer. 2015 Dec;23(12):3411-9. doi: 10.1007/s00520-015-2690-0. Epub 2015 Mar 10.