- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00034970
Mindfulness-Based Art Therapy for Cancer Patients
August 17, 2006 updated by: National Center for Complementary and Integrative Health (NCCIH)
The purpose of this study is to determine whether cancer patients who receive the mindfulness-based art therapy (MBAT) program demonstrate improvement in health-related quality of life, a reduction in stress-related symptoms, and enhanced coping responses.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Psychosocial interventions, especially supportive-expressive group therapies, have been associated with significant improvements in health status, quality of life and coping behaviors, in patients with cancer.
The purpose of the proposed pilot research study is to investigate a newly developed group therapy for cancer patients, MBAT.
This proposed, randomized, controlled study follows a successful preliminary investigation of MBAT conducted at Thomas Jefferson University Hospital.
MBAT integrates known benefits of art therapy, group therapy, and mindfulness-based stress reduction.
Each of these fundamentally different modalities has documented usefulness in the treatment of cancer patients.
The multi-modal approach is designed to enhance both the supportive and expressive aspects of the group experience.
The study will be done with 96 patients who have a variety of cancer types.
Participants will be matched for age and assigned randomly to either the MBAT experimental group or a non-intervention control group.
Both groups will continue to receive their usual oncologic/medical care.
The MBAT program consists of eight weekly meetings of two and one half-hours in length.
At the end of the eight weeks, participants in the control group will be crossed over to the experimental intervention arm for an additional eight weeks.
Participants will be assessed pre- and post-intervention on measures of health-related quality of life, psychological distress, and coping, using standardized outcome instruments (SF-36, SCL-90-R and COPE).
Our long-term goal is to collect sufficient data to determine the overall efficacy of this promising intervention and to identify which patients are particularly likely to benefit from MBAT.
Study Type
Interventional
Enrollment
114
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University Hospital/Kimmel Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion:
- Diagnosis of cancer or cancer recurrence within the past 2 years.
- Able to tolerate 8 weekly groups, 2 1/2 hours in length
Exclusion:
- Less than 4 months from original or recurrent diagnosis or beyond 2 years
- Physically unable to attend groups
- Non-stabilized major mental disorder
- Children
- Comprehension of written and spoken English at a level of less than 4th grade.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: ECT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: NONE
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Daniel A. Monti, MD, Thomas Jefferson University
- Study Director: Caroline Peterson, MA, Thomas Jefferson University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Reibel DK, Greeson JM, Brainard GC, Rosenzweig S. Mindfulness-based stress reduction and health-related quality of life in a heterogeneous patient population. Gen Hosp Psychiatry. 2001 Jul-Aug;23(4):183-92. doi: 10.1016/s0163-8343(01)00149-9.
- Speca M, Carlson LE, Goodey E, Angen M. A randomized, wait-list controlled clinical trial: the effect of a mindfulness meditation-based stress reduction program on mood and symptoms of stress in cancer outpatients. Psychosom Med. 2000 Sep-Oct;62(5):613-22. doi: 10.1097/00006842-200009000-00004.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2002
Study Completion
December 1, 2003
Study Registration Dates
First Submitted
May 2, 2002
First Submitted That Met QC Criteria
May 2, 2002
First Posted (ESTIMATE)
May 3, 2002
Study Record Updates
Last Update Posted (ESTIMATE)
August 18, 2006
Last Update Submitted That Met QC Criteria
August 17, 2006
Last Verified
July 1, 2006
More Information
Terms related to this study
Keywords
- quality of life
- cancer
- coping
- meditation
- outcomes research
- patient oriented research
- human therapy evaluation
- stress management
- alternative medicine
- support
- group therapy
- neoplasm /cancer chemotherapy
- art
- holistic
- combination cancer therapy
- creative-expression
- gender difference
- psychological aspect of cancer
- psychological stressor
- racial /ethnic difference
- behavioral /social science research
Other Study ID Numbers
- R21AT000683-01 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.