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| Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
| Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
| ClinicalTrials.gov Identifier: | NCT00034970 |
Purpose
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.
| Condition | Intervention |
|
Cancer |
Behavioral: Mindfulness-based at therapy |
| Genetics Home Reference related topics: | Benign Tumors Cancer |
| MedlinePlus related topics: | Cancer |
| ChemIDplus related topics: | Attapulgite Bismuth subsalicylate Kaopectate |
| Study Type: | Interventional |
| Study Design: | Educational/Counseling/Training, Randomized, Open Label, Factorial Assignment, Efficacy Study |
| Official Title: | Mindfulness-Based Art Therapy for Cancer Patients |
| Estimated Enrollment: | 114 |
| Study Start Date: | April 2002 |
| Estimated Study Completion Date: | December 2003 |
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.
Eligibility
| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
Contacts and Locations| United States, Pennsylvania | |||||
| Thomas Jefferson University Hospital/Kimmel Cancer Center | |||||
| Philadelphia, Pennsylvania, United States, 19107 | |||||
| Principal Investigator: | Daniel A. Monti, MD | Thomas Jefferson University |
| Study Director: | Caroline Peterson, MA | Thomas Jefferson University |
More Information
| Study ID Numbers: | R21 AT000683-01 |
| First Received: | May 2, 2002 |
| Last Updated: | August 17, 2006 |
| ClinicalTrials.gov Identifier: | NCT00034970 |
| Health Authority: | United States: Federal Government |
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