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Clinical Trials/NCT01860365
NCT01860365UnknownNot Applicable

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

Carmel Medical Center1 site in 1 country2,500 target enrollmentStarted: July 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
2,500
Locations
1
Primary Endpoint
ESAS (Edmonton Symptom Assessment Scale)questionnaire

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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

Intervention: Complementary medicine consultation and treatment (Other)

Conventional supportive care

Active Comparator

Patients receiving conventional supportive care

Intervention: Patients receiving conventional supportive care (Other)

Outcomes

Primary Outcomes

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

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

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.

Secondary Outcomes

  • FACIT-Sp-12 questionnaire(2-4 months)
  • Attitudes concerning complementary medicine(6-12 weeks)

Investigators

Sponsor
Carmel Medical Center
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Eran Ben-Arye

Integrative oncology Program, Director

Carmel Medical Center

Study Sites (1)

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