Exercise Program or Health Education Program in Reducing Fatigue and Pain in Breast Cancer Survivors
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer, Cancer, Chronic Pain, Other Indications |
| Therapuetic Areas: | Musculoskeletal, Oncology, Other |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 4/2/2016 |
| Start Date: | January 2006 |
The Effects of Cross Training on Fatigue and Pain Levels in Breast Cancer Survivors
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.
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:
- 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.
- 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.
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
We found this trial at
2
sites
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5665 Peachtree Dunwoody Rd NE
Atlanta, Georgia 30342
Atlanta, Georgia 30342
(678) 843-7001
Saint Joseph's Hospital of Atlanta Founded by the Sisters of Mercy in 1880, Saint Joseph
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