Exercise Program or Health Education Program in Reducing Fatigue and Pain in Breast Cancer Survivors
Recruitment status was: Recruiting
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.
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
|Study Design:||Allocation: Randomized|
|Official Title:||The Effects of Cross Training on Fatigue and Pain Levels in Breast Cancer Survivors|
|Study Start Date:||January 2006|
|Estimated Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00336089
|United States, Georgia|
|Saint Joseph's Hospital of Atlanta||Recruiting|
|Atlanta, Georgia, United States, 30342-1701|
|Contact: Clinical Trials Office - Saint Joseph's Hospital of Atlanta 404-851-7115|
|Clayton State University||Recruiting|
|Morrow, Georgia, United States, 30260-0285|
|Contact: Melanie Poudevigne, PhD 678-466-4937 firstname.lastname@example.org|
|Study Chair:||Melanie Poudevigne, PhD||Clayton State University|