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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01860365
• Other study ID #: CMC-09-0024-CTIL
• Status: Recruiting
• Phase: N/A
• Start date: July 2009
• Est. completion date: September 1, 2025

Study information

• Verified date: February 2024
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Quality of Life

Intervention

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.
• 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.

Locations

Country	Name	City	State
Israel	Lin Zebulon and Carmel Medical centers	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complementary medicine side-effects documentation	Documentation in registry protocol of patients' reported side-effects concerning complementary medicine treatments	6-12 weeks(+follow-up 4 months)
Primary	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)
Primary	ESAS (Edmonton Symptom Assessment Scale)questionnaire	Assessing the severity of 10 leading symptoms and well-being	6-12 weeks(+follow-up 4 months)
Primary	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	FACIT-Sp-12 questionnaire	Assessing patients' spiritual well-being	2-4 months
Secondary	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	6-12 weeks