The Effect Of Meditation On Quality Of Life In Women With Breast Cancer And Other Gynecological Cancers
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Weill Medical College of Cornell University.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Weill Medical College of Cornell University
Collaborator:
Avon Foundation
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00248911
First received: November 3, 2005
Last updated: April 10, 2008
Last verified: April 2008
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Purpose
Women with breast cancer and other gynecologic cancers 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 these conditions decrease their suffering and improve their quality of life.
| Condition | Intervention |
|---|---|
|
Breast Cancers Gynecologic Cancer |
Behavioral: Mindfulness based meditation program |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | The Effect Of Meditation On Quality Of Life In Women With Breast Cancer And Other Gynecological Cancers:Avon Program for Meditation and Healing |
Resource links provided by NLM:
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: | 200 |
| 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:
Detailed Description:
-
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
The objective of this project in women recently treated for breast or other gynecologic 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 or other gynecologic 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 cancer are excluded.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00248911
Locations
| United States, New York | |
| Weill Cornell Medical College-New York Hospital | |
| New York, New York, United States, 10065 | |
Sponsors and Collaborators
Weill Medical College of Cornell University
Avon Foundation
Investigators
| Principal Investigator: | Mary E Charlson, MD | Weill Medical College of Cornell University |
| Principal Investigator: | Joseph Loizzo, MD,PhD-interventionist | Center for Complementary and Intergrative Medicine, New York Presbyterian Hospital-Weill Cornell Medical College |
More Information
No publications provided
| Responsible Party: | Mary E. Charlson, MD, Weill Cornell Medical College |
| ClinicalTrials.gov Identifier: | NCT00248911 History of Changes |
| Other Study ID Numbers: | 0209005792 |
| Study First Received: | November 3, 2005 |
| Last Updated: | April 10, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Weill Medical College of Cornell University:
|
Breast cancer Gynecologic cancers Meditation Stress-reduction Cognitive-affective behavioral learning |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 23, 2013