Breast Cancer Rehabilitation Program in Improving Quality of Life in Breast Cancer Survivors
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| First Received Date ICMJE | April 28, 2010 | ||||
| Last Updated Date | November 16, 2012 | ||||
| Start Date ICMJE | June 2010 | ||||
| Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT01113554 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 | Breast Cancer Rehabilitation Program in Improving Quality of Life in Breast Cancer Survivors | ||||
| Official Title ICMJE | A Pilot Study to Evaluate the Feasibility of a Breast Cancer Rehabilitation Program in Survivors of Breast Cancer | ||||
| Brief Summary | RATIONALE: A breast cancer rehabilitation program and exercise therapy may help improve the quality of life of breast cancer survivors. PURPOSE: This clinical trial studies a breast cancer rehabilitation program in improving quality of life in breast cancer survivors. |
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| Detailed Description | PRIMARY OBJECTIVES: I. To estimate accrual, retention, adherence, and participation of breast cancer survivors to a breast cancer rehabilitation program. II. To estimate the variability of weight, six-minute walk, quality of life and other psychosocial and physical measures in women participating in the BCRP. SECONDARY OBJECTIVES: I. To assess changes in the anthropometric, psychosocial, and physical outcomes over the six-month period of the BCRP. II. To document the types and the rates of adverse events associated with the BCRP. OUTLINE: Patients attend exercise therapy sessions over 1 hour 3 times a week for 6 months. Exercise therapy sessions are comprised of a 10 minute warm-up of light stretching and aerobic type exercise (walking, cycling), 30 minutes of endurance type exercise (cycle, walking), and 20 minutes of resistance training exercise. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Intervention ICMJE |
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| Study Arm (s) | Experimental: Arm I
Patients attend exercise therapy sessions over 1 hour 3 times a week for 6 months. Exercise therapy sessions are comprised of a 10 minute warm-up of light stretching and aerobic type exercise (walking, cycling), 30 minutes of endurance type exercise (cycle, walking), and 20 minutes of resistance training exercise.
Interventions:
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| 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 | 25 | ||||
| Estimated Completion Date | June 2013 | ||||
| Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion
Exclusion
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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 | NCT01113554 | ||||
| Other Study ID Numbers ICMJE | CCCWFU 99309, NCI-2010-00975 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Comprehensive Cancer Center of Wake Forest University | ||||
| Study Sponsor ICMJE | Comprehensive Cancer Center of Wake Forest University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Comprehensive Cancer Center of Wake Forest University | ||||
| Verification Date | November 2012 | ||||
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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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