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Mind-Body Program for Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00179387
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : January 24, 2017
Information provided by (Responsible Party):

September 13, 2005
September 16, 2005
January 24, 2017
December 1, 2004
February 25, 2016   (Final data collection date for primary outcome measure)
Functional Assessment of Cancer Therapy [ Time Frame: baseline to 2 months and 4 months ]
Not Provided
Complete list of historical versions of study NCT00179387 on ClinicalTrials.gov Archive Site
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Mind-Body Program for Cancer Patients
Evaluation of Mind-Body Groups on the Quality of Life of Cancer Patients
The purpose of this study is to find out if Mind-Body groups can help improve the physical and emotional well-being of people facing cancer or its treatment.
Pain, fatigue, anxiety, depression, nausea, sexual impairment, body image disturbance, relationship strains, existential distress and role losses are all potential "side-effects" of living with cancer and its treatment. Behavioral interventions have shown some success in mitigating distress and QOL impairment among cancer patients. The purpose of this randomized-controlled study is to compare the effects of Mind-body group interventions on the quality of life of patients with advanced cancer. Patients are randomized to one of two psychotherapy groups, which occur weekly for eight weeks. Quality of life assessments are conducted at baseline and two and four-month intervals.
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Behavioral: Mind-Body Psychotherapy Group
    Psycho-educational group
    Other Name: Stress Management Group
  • Behavioral: Mind-Body Psychotherapy Group
    Spiritual-Existential Group
    Other Name: Spiritual Support Group
  • Active Comparator: 1
    Psycho-educational / Stress Management group
    Intervention: Behavioral: Mind-Body Psychotherapy Group
  • Active Comparator: 2
    Spiritual-Existential Support Group
    Intervention: Behavioral: Mind-Body Psychotherapy Group
Stein EM, Kolidas E, Moadel A. Do spiritual patients want spiritual interventions?: A qualitative exploration of underserved cancer patients' perspectives on religion and spirituality. Palliat Support Care. 2015 Feb;13(1):19-25. doi: 10.1017/S1478951513000217. Epub 2013 Aug 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
February 25, 2016
February 25, 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • On Active Treatment for:

Breast Cancer Stage IV, Colorectal Cancer Stage IV, Lung Cancer Stages III & IV, or All Other Cancers (ANY stage on treatment)

  • Language is English or Spanish

Exclusion Criteria:

  • Patient is currently attending other support/psychotherapy group
  • Significant Cognitive Impairment
  • ECOG performance status = 3 or 4
  • Current major untreated psychiatric disorder
  • Unable to attend intervention in following 8 weeks due to medical or practical restrictions
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
IRB #2003-412
ACS Research Scholar's Grant
Not Provided
Not Provided
Alyson Moadel, Albert Einstein College of Medicine of Yeshiva University
Albert Einstein College of Medicine, Inc.
American Cancer Society, Inc.
Principal Investigator: Alyson Moadel, Ph.D. Albert Einstein College of Medicine, Inc.
Albert Einstein College of Medicine, Inc.
January 2017

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