Avon Foundation Program to Improve Quality of Life in Breast Cancer Survivors
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness based meditation program
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring Meditation, Stress-reduction, Cognitive-affective behavior learning
Eligibility 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.
Sites / Locations
- The New York Presbyterian Hospital-Weill Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mindfulness based meditation program
Arm Description
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.
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00278837
First Posted
January 13, 2006
Last Updated
February 17, 2017
Sponsor
Weill Medical College of Cornell University
Collaborators
Avon Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00278837
Brief Title
Avon Foundation Program to Improve Quality of Life in Breast Cancer Survivors
Official Title
Contemplative Self-Healing to Improve Quality of Life in Breast Cancer Survivors: the Avon Foundation Program to Reach Medically Underserved Populations
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 2003 (Actual)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Avon Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Meditation, Stress-reduction, Cognitive-affective behavior learning
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness based meditation program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness based meditation program
Other Intervention Name(s)
Meditation and Breast Cancer
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
101 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary E Charlson, MD
Organizational Affiliation
Weill Medical College of Cornell
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph Loizzo, MD, PhD
Organizational Affiliation
Weill Medical College of Cornell University, Center for Complementary and Integrative Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The New York Presbyterian Hospital-Weill Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No Plan to Share IPD
Citations:
PubMed Identifier
25249005
Citation
Charlson ME, Loizzo J, Moadel A, Neale M, Newman C, Olivo E, Wolf E, Peterson JC. Contemplative self healing in women breast cancer survivors: a pilot study in underserved minority women shows improvement in quality of life and reduced stress. BMC Complement Altern Med. 2014 Sep 23;14:349. doi: 10.1186/1472-6882-14-349.
Results Reference
derived
Learn more about this trial
Avon Foundation Program to Improve Quality of Life in Breast Cancer Survivors
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