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

Clayton State University

Status: Unknown

Conditions: Breast Cancer; Cancer Survivor; Fatigue; Pain

Treatments: Procedure: management of therapy complications; Behavioral: exercise intervention; Procedure: fatigue assessment and management; Procedure: complementary or alternative medicine procedure; Procedure: pain therapy; Procedure: quality-of-life assessment; Other: educational intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT00336089

CDR0000466676

CSU-GCC-161

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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