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
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00336089
First received: June 8, 2006
Last updated: September 16, 2013
Last verified: July 2009

June 8, 2006
September 16, 2013
January 2006
December 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00336089 on ClinicalTrials.gov Archive Site
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Exercise Program or Health Education Program in Reducing Fatigue and Pain in Breast Cancer Survivors
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.

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.

Interventional
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Allocation: Randomized
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
54
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December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
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United States
 
NCT00336089
CDR0000466676, CSU-GCC-161
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Clayton State University
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Study Chair: Melanie Poudevigne, PhD Clayton State University
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP