- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00248911
The Effect Of Meditation On Quality Of Life In Women With Breast Cancer And Other Gynecological Cancers
February 17, 2017 updated by: Mary E. Charlson, MD, Weill Medical College of Cornell University
The Effect Of Meditation On Quality Of Life In Women With Breast Cancer And Other Gynecological Cancers:Avon Program for Meditation and Healing
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
94
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10065
- Weill Cornell Medical College-New York Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 101 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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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Subjects will complete questionnaires at baseline and closeout. Patients will participate in the meditation program weekly for 20 weeks.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Joseph Loizzo, MD,PhD, Center for Complementary and Intergrative Medicine, New York Presbyterian Hospital-Weill Cornell Medical College
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2003
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
November 3, 2005
First Submitted That Met QC Criteria
November 3, 2005
First Posted (Estimate)
November 4, 2005
Study Record Updates
Last Update Posted (Actual)
February 23, 2017
Last Update Submitted That Met QC Criteria
February 17, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0209005792
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No Plan to Share IPD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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