Avon Foundation Program to Improve Quality of Life in Breast Cancer Survivors
Recruitment status was Active, not recruiting
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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 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: 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 |
- 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) |
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Behavioral: Mindfulness based meditation program
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 |
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| United States, New York | |
| The New York Presbyterian Hospital-Weill Medical Center | |
| New York, New York, United States, 10021 | |
| 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
No publications provided
| Responsible Party: | Mary Charlson, MD, Weill Cornell Medical College |
| ClinicalTrials.gov Identifier: | NCT00278837 History of Changes |
| Other Study ID Numbers: | 0209005792(RCT) |
| Study First Received: | January 13, 2006 |
| Last Updated: | April 22, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on May 16, 2013