Breast Cancer Rehabilitation Program in Improving Quality of Life in Breast Cancer Survivors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Study to Evaluate the Feasibility of a Breast Cancer Rehabilitation Program in Survivors of Breast Cancer

Conditions
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Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer

Intervention / Treatment
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* Other: questionnaire administration
* Behavioral: exercise intervention
* Procedure: quality-of-life assessment
* Other: survey administration
* Procedure: management of therapy complications
* Procedure: psychosocial assessment and care


Participation Criteria
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Eligibility Criteria
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Inclusion First occurrence of breast cancer BMI >= 25 Recently completed treatment(chemotherapy/radiation) for breast cancer (=< 8 weeks), but can be receiving adjuvant hormonal therapy Willing to comply with study visits, as outlined in the protocol Lives within 30 miles of study site, or willing to travel to study site if outside a 30-mile radius Ability to participate in a moderate exercise program, such as freedom from any orthopedic abnormalities that would prevent participation Ability to understand and the willingness to sign a written informed consent document Exclusion Unstable angina Cardiac conduction disturbances Plans to move from the study area Dementia that is medically documented or suspected Advanced arterial disease causing ischemia of any limb Physical immobility Homebound for medical reasons Dependent on wheelchair for mobility Chronic disease which significantly reduces 4-year survival Recurrent breast cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>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. | Other: questionnaire administration<br> <br> Behavioral: exercise intervention<br> <br> Procedure: quality-of-life assessment<br> <br> * Other names: quality of life assessment;Other: survey administration<br> <br> Procedure: management of therapy complications<br> <br> * Other names: complications of therapy, management of;Procedure: psychosocial assessment and care<br> <br> * Other names: psychosocial support;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to recruit breast cancer survivors into a six-month breast cancer rehabilitation program |  | Approximately 24 months | 
| BMI |  | 6 months | 
| Muscular strength |  | 6 months | 
| Range of motion |  | 6 months | 
| Quality of life |  | 6 months | 
| Proportion of screened women who are eligible for the study and the proportion of eligible women who agree to participate |  | Approximately 24 months | 
| Proportion of women who complete the study and the average number of weeks of participation |  | Approximately 24 months |