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Exercise Program or Health Education Program in Reducing Fatigue and Pain in Breast Cancer Survivors

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00336089
First Posted: June 12, 2006
Last Update Posted: September 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  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:


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)
Detailed Description:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00336089     History of Changes
Other Study ID Numbers: CDR0000466676
CSU-GCC-161
First Submitted: June 8, 2006
First Posted: June 12, 2006
Last Update Posted: September 17, 2013
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
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
fatigue
pain

Additional relevant MeSH terms:
Breast Neoplasms
Fatigue
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms