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

September 16, 2013 updated by: Clayton State University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30342-1701
        • Recruiting
        • Saint Joseph's Hospital of Atlanta
        • Contact:
          • Clinical Trials Office - Saint Joseph's Hospital of Atlanta
          • Phone Number: 404-851-7115
      • Morrow, Georgia, United States, 30260-0285
        • Recruiting
        • Clayton State University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clayton State University

Investigators

  • Study Chair: Melanie Poudevigne, PhD, Clayton State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

June 8, 2006

First Submitted That Met QC Criteria

June 8, 2006

First Posted (Estimate)

June 12, 2006

Study Record Updates

Last Update Posted (Estimate)

September 17, 2013

Last Update Submitted That Met QC Criteria

September 16, 2013

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000466676
  • CSU-GCC-161

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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