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

February 17, 2024 updated by: Eran Ben-Arye, Carmel Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

2500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 35152
        • Recruiting
        • Lin Zebulon and Carmel Medical centers
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Ilanit Shalom-Sharabi, RN MA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
Active Comparator: Conventional supportive care
Patients receiving conventional supportive care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MYCAW (Measure Yourself Concerns and Wellbeing)questionnaire
Time Frame: 6-12 weeks(+follow-up 4 months)
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
Time Frame: 6-12 weeks(+follow-up 4 months)
Assessing the severity of 10 leading symptoms and well-being
6-12 weeks(+follow-up 4 months)
EORTC QLQ-C30
Time Frame: 6-12 weeks(+follow-up 4 months)
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
Time Frame: 2-4 months
Assessing patients' spiritual well-being
2-4 months
Attitudes concerning complementary medicine
Time Frame: 6-12 weeks
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complementary medicine side-effects documentation
Time Frame: 6-12 weeks(+follow-up 4 months)
Documentation in registry protocol of patients' reported side-effects concerning complementary medicine treatments
6-12 weeks(+follow-up 4 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carmel Medical Center

Investigators

  • Principal Investigator: Eran Ben-Arye, MD, Clalit Health Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

May 20, 2013

First Submitted That Met QC Criteria

May 21, 2013

First Posted (Estimated)

May 22, 2013

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 17, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CMC-09-0024-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Quality of Life

Clinical Trials on Complementary medicine consultation and treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe