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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00034970
Other study ID # R21AT000683-01
Secondary ID
Status Completed
Phase N/A
First received May 2, 2002
Last updated August 17, 2006
Start date April 2002
Est. completion date December 2003

Study information

Verified date July 2006
Source National Center for Complementary and Integrative Health (NCCIH)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 114
Est. completion date December 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training


Related Conditions & MeSH terms


Intervention

Behavioral:
Mindfulness-based at therapy


Locations

Country Name City State
United States Thomas Jefferson University Hospital/Kimmel Cancer Center Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

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