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Mindfulness-Based Art Therapy for Cancer Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00034970
First Posted: May 3, 2002
Last Update Posted: August 18, 2006
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.
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: Mindfulness-Based Art Therapy for Cancer Patients

Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):

Estimated Enrollment: 114
Study Start Date: April 2002
Estimated Study Completion Date: December 2003
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

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:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  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): NCT00034970


Locations
United States, Pennsylvania
Thomas Jefferson University Hospital/Kimmel Cancer Center
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Daniel A. Monti, MD Thomas Jefferson University
Study Director: Caroline Peterson, MA Thomas Jefferson University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00034970     History of Changes
Other Study ID Numbers: R21AT000683-01 ( U.S. NIH Grant/Contract )
First Submitted: May 2, 2002
First Posted: May 3, 2002
Last Update Posted: August 18, 2006
Last Verified: July 2006

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
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