Avon Foundation Program to Improve Quality of Life in Breast Cancer Survivors - Full Text View

Purpose

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.

Condition	Intervention
Breast Cancer	Behavioral: Mindfulness based meditation program

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer Stress

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Open Label, Uncontrolled, Single Group Assignment

Official Title:	Contemplative Self-Healing to Improve Quality of Life in Breast Cancer Survivors: the Avon Foundation Program to Reach Medically Underserved Populations

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	May 2003
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Subjects will participate in an intervention consisting of group and individual instruction in a meditation-based practice of stress-reduction and cognitive-affective-behavioral learning.

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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:

Patients who refuse to participate will be excluded
Patients with metastatic (stage IV) cancer are excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00278837

Locations


United States, New York
	The New York Presbyterian Hospital-Weill Medical Center
	New York, New York, United States, 10021

Sponsors and Collaborators

Weill Medical College of Cornell University

Avon Foundation

Investigators


Principal Investigator:	Mary E Charlson, MD	Weill Medical College of Cornell

Principal Investigator:	Joseph Loizzo, MD, PhD	Weill Medical College of Cornell University, Center for Complementary and Integrative Medicine

More Information

Responsible Party:	Weill Cornell Medical College ( Mary Charlson, MD )
Study ID Numbers:	0209005792(RCT)
First Received:	January 13, 2006
Last Updated:	April 22, 2008
ClinicalTrials.gov Identifier:	NCT00278837
Health Authority:	United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:

Meditation

Stress-reduction

Cognitive-affective behavior learning

Study placed in the following topic categories:

Skin Diseases

Quality of Life

Stress

Breast Neoplasms

Breast Diseases

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on October 24, 2008

Sponsors and Collaborators:	Weill Medical College of Cornell University Avon Foundation
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00278837