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Avon Foundation Program to Improve Quality of Life in Breast Cancer Survivors

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ClinicalTrials.gov Identifier: NCT00278837
Recruitment Status : Completed
First Posted : January 18, 2006
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
Avon Foundation
Information provided by (Responsible Party):
Mary E. Charlson, MD, Weill Medical College of Cornell University

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Mindfulness based meditation program Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Contemplative Self-Healing to Improve Quality of Life in Breast Cancer Survivors: the Avon Foundation Program to Reach Medically Underserved Populations
Actual Study Start Date : May 2003
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Mindfulness based meditation program
Meditation and Breast Cancer: 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.
Behavioral: Mindfulness based meditation program
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.
Other Name: Meditation and Breast Cancer



Primary Outcome Measures :
  1. 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. ]


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Ages Eligible for Study:   18 Years to 101 Years   (Adult, Senior)
Sexes 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:

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

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): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mary E. Charlson, MD, Principal Investigator, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00278837     History of Changes
Other Study ID Numbers: 0209005792(RCT)
First Posted: January 18, 2006    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No Plan to Share IPD

Keywords provided by Mary E. Charlson, MD, Weill Medical College of Cornell University:
Meditation
Stress-reduction
Cognitive-affective behavior learning

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases