Clinical trial NCT00034970: Mindfulness-Based Art Therapy for Cancer Patients
Official title: Mindfulness-Based Art Therapy for Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: alternative medicine
art
cancer
combination cancer therapy
creative-expression
group therapy
holistic
human therapy evaluation
meditation
neoplasm /cancer chemotherapy
coping
gender difference
outcomes research
psychological aspect of cancer
psychological stressor
quality of life
racial /ethnic difference
stress management
support
behavioral /social science research
patient oriented research
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2002-05-03
Enrollment: 114
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: ECT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital/Kimmel Cancer Center
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Daniel A. Monti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thomas Jefferson University
name: Caroline Peterson, MA
role: STUDY_DIRECTOR
References:
citation: 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.
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. doi: 10.1097/00006842-200009000-00004.