Exercise Program or Health Education Program in Reducing Fatigue and Pain in Breast Cancer Survivors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effects of Cross Training on Fatigue and Pain Levels in Breast Cancer Survivors

Conditions
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Breast Cancer, Cancer Survivor, Fatigue, Pain

Intervention / Treatment
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* Behavioral: exercise intervention
* Other: educational intervention
* Procedure: complementary or alternative medicine procedure
* Procedure: fatigue assessment and management
* Procedure: management of therapy complications
* Procedure: pain therapy
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

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

Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: exercise intervention|nan|
|Other: educational intervention|nan|
|Procedure: complementary or alternative medicine procedure|nan|
|Procedure: fatigue assessment and management|nan|
|Procedure: management of therapy complications|nan|
|Procedure: pain therapy|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inflammatory breast cancer, fatigue, pain, cancer survivor, breast cancer in situ, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer