Exercise Program or Health Education Program in Reducing Fatigue and Pain in Breast Cancer Survivors
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Clayton State University
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00336089
First received: June 8, 2006
Last updated: October 14, 2010
Last verified: July 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer Cancer Survivor Fatigue Pain |
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 Type: | Interventional |
| Study Design: | Allocation: Randomized |
| Official Title: | The Effects of Cross Training on Fatigue and Pain Levels in Breast Cancer Survivors |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Breast Cancer
Breast Diseases
Cancer
Exercise and Physical Fitness
Fatigue
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
| Estimated Enrollment: | 54 |
| Study Start Date: | January 2006 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00336089
Locations
| 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 mpoudevigne@clayton.edu | |
Sponsors and Collaborators
Clayton State University
Investigators
| Study Chair: | Melanie Poudevigne, PhD | Clayton State University |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00336089 History of Changes |
| Other Study ID Numbers: | CDR0000466676, CSU-GCC-161 |
| Study First Received: | June 8, 2006 |
| Last Updated: | October 14, 2010 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
fatigue pain cancer survivor breast cancer in situ inflammatory breast cancer 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 |
Additional relevant MeSH terms:
|
Breast Neoplasms Fatigue Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013