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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

May 20, 2013
May 22, 2013
January 30, 2018
July 2009
September 2019   (Final data collection date for primary outcome measure)
  • 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
  • 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
  • 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.
Same as current
Complete list of historical versions of study NCT01860365 on ClinicalTrials.gov Archive Site
  • FACIT-Sp-12 questionnaire [ Time Frame: 2-4 months ]
    Assessing patients' spiritual well-being
  • 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
Same as current
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
Same as current
 
Measuring Concerns of Cancer Patients Referred to Complementary Medicine Treatment Integrated Within Oncology Service
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.
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.
Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Quality of Life
  • 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.
  • 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.
  • 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
    Intervention: Other: Complementary medicine consultation and treatment
  • Active Comparator: Conventional supportive care
    Patients receiving conventional supportive care
    Intervention: Other: Patients receiving conventional supportive care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
980
Same as current
September 2019
September 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Israel
 
 
NCT01860365
CMC-09-0024-CTIL
Yes
Not Provided
Plan to Share IPD: Undecided
Eran Ben-Arye, Carmel Medical Center
Carmel Medical Center
Not Provided
Principal Investigator: Eran Ben-Arye, MD Clalit Health Services
Carmel Medical Center
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP