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Trial record 5 of 292 for:    complementary and alternative medicine

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

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ClinicalTrials.gov Identifier: NCT01860365
Recruitment Status : Recruiting
First Posted : May 22, 2013
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Eran Ben-Arye, Carmel Medical Center

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.

Condition or disease Intervention/treatment Phase
Quality of Life Other: Complementary medicine consultation and treatment Other: Patients receiving conventional supportive care Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 980 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Measuring Concerns and Needs of Cancer Patients Referred to Complementary Medicine Treatment Integrated Within the Oncology Service
Study Start Date : July 2009
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

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.



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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 Outcome Measures :
  1. FACIT-Sp-12 questionnaire [ Time Frame: 2-4 months ]
    Assessing patients' spiritual well-being

  2. 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


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01860365


Locations
Israel
Lin Zebulon and Carmel Medical centers Recruiting
Haifa, Israel, 35152
Contact: Eran Ben-Arye, MD    972528709282 ext 0    eranbe@clalit.org.il   
Contact: Ilanit Shalom-Sharabi, RN MA    97252948423 ext 0    ilanitsh10@walla.co.il   
Sub-Investigator: Ilanit Shalom-Sharabi, RN MA         
Sponsors and Collaborators
Carmel Medical Center
Investigators
Principal Investigator: Eran Ben-Arye, MD Clalit Health Services

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eran Ben-Arye, Integrative oncology Program, Director, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01860365     History of Changes
Other Study ID Numbers: CMC-09-0024-CTIL
First Posted: May 22, 2013    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Eran Ben-Arye, Carmel Medical Center:
Quality of life
Integrative medicine
Supportive care
Cancer
Chemotherapy