Avon Foundation Program to Improve Quality of Life in Breast Cancer Survivors
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:
NCT00278837
First received: January 13, 2006
Last updated: April 22, 2008
Last verified: April 2008
| Tracking Information | |||||||||
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| First Received Date ICMJE | January 13, 2006 | ||||||||
| Last Updated Date | April 22, 2008 | ||||||||
| Start Date ICMJE | May 2003 | ||||||||
| Estimated Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE |
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. | ||||||||
| Change History | Complete list of historical versions of study NCT00278837 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Avon Foundation Program to Improve Quality of Life in Breast Cancer Survivors | ||||||||
| Official Title ICMJE | Contemplative Self-Healing to Improve Quality of Life in Breast Cancer Survivors: the Avon Foundation Program to Reach Medically Underserved Populations | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | Breast Cancer | ||||||||
| Intervention ICMJE | 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 |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 160 | ||||||||
| Estimated Completion Date | March 2010 | ||||||||
| Estimated Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | 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:
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| Gender | Female | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00278837 | ||||||||
| Other Study ID Numbers ICMJE | 0209005792(RCT) | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Mary Charlson, MD, Weill Cornell Medical College | ||||||||
| Study Sponsor ICMJE | Weill Medical College of Cornell University | ||||||||
| Collaborators ICMJE | Avon Foundation | ||||||||
| Investigators ICMJE |
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| Information Provided By | Weill Medical College of Cornell University | ||||||||
| Verification Date | April 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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