NCT01860365

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for not_applicable quality-of-life

Timeline
Completed

Started Jul 2009

Longer than P75 for not_applicable quality-of-life

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2013

Completed
12.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

16.2 years

First QC Date

May 20, 2013

Last Update Submit

February 17, 2024

Conditions

Quality of Life

Keywords

Quality of lifeIntegrative medicineSupportive careCancerChemotherapy

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • FACIT-Sp-12 questionnaire

    2-4 months

  • Attitudes concerning complementary medicine

    6-12 weeks

Other Outcomes (1)

  • Complementary medicine side-effects documentation

    6-12 weeks(+follow-up 4 months)

Study Arms (2)

Complementary medicine counseling

EXPERIMENTAL

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

Conventional supportive care

ACTIVE COMPARATOR

Patients receiving conventional supportive care

Other: Patients receiving conventional supportive care

Interventions

Complementary medicine consultation and treatmentOTHER

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.

Complementary medicine counseling
Patients receiving conventional supportive careOTHER

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.

Conventional supportive care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age younger than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lin Zebulon and Carmel Medical centers

Haifa, 35152, Israel

RECRUITING

Related Publications (6)

  • 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.

    PMID: 37787815DERIVED

  • 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.

    PMID: 34435403DERIVED

  • 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.

    PMID: 28710110DERIVED

  • 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.

    PMID: 27169571DERIVED

  • 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.

    PMID: 26361759DERIVED

  • 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.

    PMID: 25752885DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Therapeutics

Study Officials

  • Eran Ben-Arye, MD

    Clalit Health Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Integrative oncology Program, Director

Study Record Dates

First Submitted

May 20, 2013

First Posted

May 22, 2013

Study Start

July 1, 2009

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

February 20, 2024

Record last verified: 2024-02

Locations

IL(1)