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Mind-Body Program for Cancer Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00179387
First Posted: September 16, 2005
Last Update Posted: January 24, 2017
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.
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Alyson Moadel, Albert Einstein College of Medicine of Yeshiva University
  Purpose
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
Neoplasms Behavioral: Mind-Body Psychotherapy Group

Study Type: Interventional
Study Design: 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

Further study details as provided by Alyson Moadel, 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 ]

Enrollment: 166
Actual Study Start Date: December 1, 2004
Study Completion Date: February 25, 2016
Primary Completion Date: February 25, 2016 (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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
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): NCT00179387


Locations
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.
Investigators
Principal Investigator: Alyson Moadel, Ph.D. Albert Einstein College of Medicine, Inc.
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alyson Moadel, Associate Professor, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT00179387     History of Changes
Other Study ID Numbers: IRB #2003-412
ACS Research Scholar's Grant
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: January 24, 2017
Last Verified: January 2017

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