Breast Cancer Clinical Trial
Exercise Program or Health Education Program in Reducing Fatigue and Pain in Breast Cancer Survivors
Summary
RATIONALE: An exercise program or health education program may help relieve fatigue and pain and improve the quality of life in women who are breast cancer survivors. It is not yet known whether an exercise program is more effective than a health education program or no program in reducing fatigue and pain in women who are breast cancer survivors.
PURPOSE: This randomized clinical trial is studying an exercise program to see how well it works in reducing fatigue and pain compared to a health education program or no program in women who are breast cancer survivors.
Full Description
OBJECTIVES:
Determine whether a moderate-intensity exercise program comprising cardiorespiratory and resistance training of the legs, back, abdominal, trunk, and arm musculature vs a control group attenuates fatigue and pain in breast cancer survivors.
Determine whether this exercise program will significantly improve the quality of life of these patients.
Determine whether this exercise program can significantly reduce the number of days of absenteeism from work in these patients.
Determine whether this exercise program can significantly attenuate mood disturbances in these patients.
OUTLINE: This is a randomized, controlled, pilot study. Patients are randomized to 1 of 2 treatment arms.
Arm I (exercise program): Patients participate in an exercise program comprising cardiorespiratory (walking on a treadmill) and resistance training for 1 hour, 3 times weekly for 12 weeks.
Arm II (control): Patients undergo no intervention. In both arms, patients complete questionnaires regarding general health, mood, work attendance, and physical activity before the start of study treatment and then every 3 weeks for 12 weeks. Patients also complete a 7-day physical activity diary and sleep diary every 3 weeks.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Breast cancer survivor
Received adjuvant chemotherapy or radiotherapy for breast cancer only
Must have completed treatment 2-6 months ago
Hormone receptor status not specified
PATIENT CHARACTERISTICS:
Female
Menopausal status not specified
Hemoglobin ≥ 11 g/dL
Able to read English
No high-risk for cardiovascular problems during exercise, including any of the following:
Unstable heart disease
Unstable angina
Chronic respiratory disease
Dizziness
Uncontrolled hypertension
No severe respiratory disease requiring oxygen therapy
No history of anorexia (body mass index [BMI] < 18.5) or severe obesity (BMI > 35)
No history of multiple cancers
No shortness of breath or hypotension
No sudden swelling of the ankles, hands or face
No palpitations or arrhythmias
No persistent and intolerable pain
No major acute illness (e.g., fever or respiratory infection)
PRIOR CONCURRENT THERAPY:
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