Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Mind-Body Program for Cancer Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by Albert Einstein College of Medicine of Yeshiva University.
Recruitment status was:  Recruiting
American Cancer Society, Inc.
Information provided by (Responsible Party):
Alyson Moadel, Albert Einstein College of Medicine of Yeshiva University Identifier:
First received: September 13, 2005
Last updated: February 1, 2012
Last verified: February 2012
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 Intervention
Behavioral: Mind-Body Psychotherapy Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Evaluation of Mind-Body Groups on the Quality of Life of Cancer Patients

Resource links provided by NLM:

Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • Functional Assessment of Cancer Therapy [ Time Frame: baseline to 2 months and 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: December 2004
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00179387

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

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 
Study First Received: September 13, 2005
Last Updated: February 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
Needs Assessment
Adaptation Psychological
Minority Groups
Psychotherapy, Group
Program Evaluation
Spiritual Therapies processed this record on December 09, 2016