Exercise Program or Health Education Program in Reducing Fatigue and Pain in Breast Cancer Survivors
NCT ID: NCT00336089
Last Updated: 2013-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
54 participants
INTERVENTIONAL
2006-01-31
Brief Summary
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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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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
Interventions
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exercise intervention
educational intervention
complementary or alternative medicine procedure
fatigue assessment and management
management of therapy complications
pain therapy
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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Clayton State University
OTHER
Principal Investigators
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Melanie Poudevigne, PhD
Role: STUDY_CHAIR
Clayton State University
Locations
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Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States
Clayton State University
Morrow, Georgia, United States
Countries
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Facility Contacts
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Clinical Trials Office - Saint Joseph's Hospital of Atlanta
Role: primary
Melanie Poudevigne, PhD
Role: primary
Other Identifiers
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CSU-GCC-161
Identifier Type: -
Identifier Source: secondary_id
CDR0000466676
Identifier Type: -
Identifier Source: org_study_id