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| ID | Type | Description | Link |
|---|---|---|---|
| CSU-GCC-161 |
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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.
OBJECTIVES:
OUTLINE: This is a randomized, controlled, pilot study. Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exercise intervention | Behavioral | |||
| educational intervention | Other | |||
| complementary or alternative medicine procedure | Procedure | |||
| fatigue assessment and management | Procedure | |||
| management of therapy complications | Procedure | |||
| pain therapy | Procedure | |||
| quality-of-life assessment | Procedure |
DISEASE CHARACTERISTICS:
Breast cancer survivor
Received adjuvant chemotherapy or radiotherapy for breast cancer only
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:
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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| Name | Affiliation | Role |
|---|---|---|
| Melanie Poudevigne, PhD | Clayton State University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Joseph's Hospital of Atlanta | Recruiting | Atlanta | Georgia | 30342-1701 | United States |
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| Clayton State University | Recruiting | Morrow | Georgia | 30260-0285 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D005221 | Fatigue |
| D010146 | Pain |
| D000071960 | Breast Carcinoma In Situ |
| D058922 | Inflammatory Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D013812 | Therapeutics |
| D000698 | Analgesia |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D000760 | Anesthesia and Analgesia |
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