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

NCT ID: NCT01860365

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2025-09-01

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.

Conditions

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Quality of Life

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Complementary medicine counseling

Patients receiving chemotherapy who are referred by their oncology provider to complementary medicine consultation and treatment provided in addition to conventional supportive care

Group Type EXPERIMENTAL

Complementary medicine consultation and treatment

Intervention Type OTHER

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.

Conventional supportive care

Patients receiving conventional supportive care

Group Type ACTIVE_COMPARATOR

Patients receiving conventional supportive care

Intervention Type OTHER

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.

Interventions

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Complementary medicine consultation and treatment

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.

Intervention Type OTHER

Patients receiving conventional supportive care

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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Carmel Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Eran Ben-Arye

Integrative oncology Program, Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eran Ben-Arye, MD

Role: PRINCIPAL_INVESTIGATOR

Clalit Health Services

Locations

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Lin Zebulon and Carmel Medical centers

Haifa, , Israel

Site Status RECRUITING

Countries

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Israel

Facility Contacts

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Eran Ben-Arye, MD

Role: primary

972528709282 ext. 0

Ilanit Shalom-Sharabi, RN MA

Role: backup

97252948423 ext. 0

References

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Hauzer M, Grimberg R, Samuels N, Keshet Y, Mordechai A, Dagash J, Ben-Arye E. Exploring primary care physician feedback following an integrative oncology consultation. Support Care Cancer. 2023 Oct 3;31(10):606. doi: 10.1007/s00520-023-08079-6.

Reference Type DERIVED
PMID: 37787815 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34435403 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28710110 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27169571 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26361759 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25752885 (View on PubMed)

Other Identifiers

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CMC-09-0024-CTIL

Identifier Type: -

Identifier Source: org_study_id

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