Viewing Study NCT00034970



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Study NCT ID: NCT00034970
Status: COMPLETED
Last Update Posted: 2006-08-18
First Post: 2002-05-02

Brief Title: Mindfulness-Based Art Therapy for Cancer Patients
Sponsor: National Center for Complementary and Integrative Health NCCIH
Organization: National Center for Complementary and Integrative Health NCCIH

Study Overview

Official Title: Mindfulness-Based Art Therapy for Cancer Patients
Status: COMPLETED
Status Verified Date: 2006-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 oncologicmedical 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None