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. Identifier: NCT00179387
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : January 24, 2017
American Cancer Society, Inc.
Information provided by (Responsible Party):
Alyson Moadel, Albert Einstein College of Medicine of Yeshiva University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neoplasms Behavioral: Mind-Body Psychotherapy Group Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of Mind-Body Groups on the Quality of Life of Cancer Patients
Actual Study Start Date : December 1, 2004
Actual Primary Completion Date : February 25, 2016
Actual Study Completion Date : February 25, 2016

Arm Intervention/treatment
Active Comparator: 1
Psycho-educational / Stress Management group
Behavioral: Mind-Body Psychotherapy Group
Psycho-educational group
Other Name: Stress Management Group
Active Comparator: 2
Spiritual-Existential Support Group
Behavioral: Mind-Body Psychotherapy Group
Spiritual-Existential Group
Other Name: Spiritual Support Group

Primary Outcome Measures :
  1. Functional Assessment of Cancer Therapy [ Time Frame: baseline to 2 months and 4 months ]

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00179387

United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine, Inc.
American Cancer Society, Inc.
Principal Investigator: Alyson Moadel, Ph.D. Albert Einstein College of Medicine, Inc.

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Alyson Moadel, Associate Professor, Albert Einstein College of Medicine of Yeshiva University Identifier: NCT00179387     History of Changes
Other Study ID Numbers: IRB #2003-412
ACS Research Scholar's Grant
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017

Keywords provided by Alyson Moadel, Albert Einstein College of Medicine of Yeshiva University:
Needs Assessment
Adaptation Psychological
Minority Groups
Psychotherapy, Group
Program Evaluation
Spiritual Therapies