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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00278837
First Posted: January 18, 2006
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Avon Foundation
Information provided by (Responsible Party):
Mary E. Charlson, MD, Weill Medical College of Cornell University
January 13, 2006
January 18, 2006
February 23, 2017
May 2003
March 2010   (Final data collection date for primary outcome 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. ]
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.
Complete list of historical versions of study NCT00278837 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Avon Foundation Program to Improve Quality of Life in Breast Cancer Survivors
Contemplative Self-Healing to Improve Quality of Life in Breast Cancer Survivors: the Avon Foundation Program to Reach Medically Underserved Populations
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.
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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Breast Cancer
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
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.
Intervention: Behavioral: Mindfulness based meditation program
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
94
March 2010
March 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 101 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00278837
0209005792(RCT)
No
Not Provided
Plan to Share IPD: No
Plan Description: No Plan to Share IPD
Mary E. Charlson, MD, Weill Medical College of Cornell University
Weill Medical College of Cornell University
Avon Foundation
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
Weill Medical College of Cornell University
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP