Overview

This trial is active, not recruiting.

Conditions breast cancers, gynecologic 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 200 participants
Trial identifier NCT00248911, 0209005792

Summary

Women with breast cancer and other gynecologic cancers 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 these conditions decrease their suffering and improve their quality of life.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
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 or other gynecologic cancer who have received treatment within the preceding year will be eligible for inclusion in the study. Exclusion Criteria: - Patients who refuse to participate will be excluded - Patients with Metastatic cancer are excluded.

Additional Information

Official title The Effect Of Meditation On Quality Of Life In Women With Breast Cancer And Other Gynecological Cancers:Avon Program for Meditation and Healing
Principal investigator Mary E Charlson, MD
Description The objective of this project in women recently treated for breast or other gynecologic 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.