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RecruitingNCT01860365Updated Feb 20, 2024

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

An interventional study of Complementary medicine consultation and treatment and Patients receiving conventional supportive care in Quality of Life, sponsored by Carmel Medical Center. Recruiting at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-20.

Sponsored by Carmel Medical Center · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
2,500
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Quality of Life

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Keywords

  • Quality of life
  • Integrative medicine
  • Supportive care
  • Cancer
  • Chemotherapy
03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's planned enrollment of 2,500 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.

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Lead sponsor

Carmel Medical Center is the lead sponsor of 119 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Age younger than 18 years
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,500 participants (estimated)

Study arms

  • Experimental
    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

    Other: Complementary medicine consultation and treatment

  • Active comparator
    Conventional supportive care

    Patients receiving conventional supportive care

    Other: Patients receiving conventional supportive care

Interventions

  • OtherComplementary 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.

  • OtherPatients 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.

06

What researchers measure

Primary outcomes

  1. MYCAW (Measure Yourself Concerns and Wellbeing)questionnaire

    Assessing patients'concerns and Wellbeing as well as narrative assessment of integrative care outcomes

    Time frame: 6-12 weeks(+follow-up 4 months)

  2. ESAS (Edmonton Symptom Assessment Scale)questionnaire

    Assessing the severity of 10 leading symptoms and well-being

    Time frame: 6-12 weeks(+follow-up 4 months)

  3. 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.

    Time frame: 6-12 weeks(+follow-up 4 months)

Secondary outcomes

  1. FACIT-Sp-12 questionnaire

    Assessing patients' spiritual well-being

    Time frame: 2-4 months

  2. 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

    Time frame: 6-12 weeks

Other outcomes

  1. Complementary medicine side-effects documentation

    Documentation in registry protocol of patients' reported side-effects concerning complementary medicine treatments

    Time frame: 6-12 weeks(+follow-up 4 months)

07

Study locations

1 of 1 sites recruiting
  • Lin Zebulon and Carmel Medical centers
    Haifa, 35152, Israel
    Recruiting
08

References and documents

Publications

  • 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. PubMed 34435403 ↗
  • 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. PubMed 28710110 ↗
  • 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. PubMed 27169571 ↗
  • 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. PubMed 26361759 ↗
  • 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. PubMed 25752885 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01860365
Responsible party
Eran Ben-Arye (Integrative oncology Program, Director, Carmel Medical Center) — Principal investigator
First posted
May 22, 2013
Start date
Jul 2009
Primary completion
Sep 1, 2025 (estimated)
Completion
Sep 1, 2025 (estimated)
Last update
Feb 20, 2024

Study contacts

Eran Ben-Arye, MD
principal investigator · Clalit Health Services

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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