Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment mindfulness based meditation program
Sponsor Weill Medical College of Cornell University
Collaborator Avon Foundation
Start date May 2003
End date March 2010
Trial size 160 participants
Trial identifier NCT00278837, 0209005792(RCT)

Summary

Women with breast cancer often suffer significant distress and disability from their disease. A practice of meditation-based stress reduction and cognitive-affective-behavioral learning may help women with breast cancer decrease their suffering and improve their quality of life.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose supportive care

Primary Outcomes

Measure
Quality of life will be assessed by within patient differences in the FACT-G (General Functional Assessment of Cancer Treatment Scale), as well as with the disease specific subscales at baseline and at 12 months.
time frame: Subjects will complete questionnaires at baseline and closeout. Patients will participate in the meditation program weekly for 20 weeks.

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: All women with stage I-III breast cancer who have received treatment within the preceding year will be eligible for inclusion in the study. Exclusion Criteria: 1. Patients who refuse to participate will be excluded 2. Patients with metastatic (stage IV) cancer are excluded.

Additional Information

Official title Contemplative Self-Healing to Improve Quality of Life in Breast Cancer Survivors: the Avon Foundation Program to Reach Medically Underserved Populations
Principal investigator Mary E Charlson, MD
Description The objective of this study in women recently treated for breast cancer is to determine whether an intervention program consisting of group and individual instruction in a meditation-based practice of stress-reduction and cognitive-affective-behavioral learning has the potential for reducing disabling distress and improving quality of life in a population vulnerable to the progression or recurrence of disease. Quality of life will be assessed at 12 months.
Trial information was received from ClinicalTrials.gov and was last updated in April 2008.
Information provided to ClinicalTrials.gov by Weill Medical College of Cornell University.