Recruiting

Exercise Program

Sponsor:

Clayton State University

Code:

NCT00336089

Conditions

Breast Cancer

Cancer Survivor

Fatigue

Pain

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

exercise intervention

educational intervention

complementary or alternative medicine procedure

fatigue assessment and management

management of therapy complications

Study Details

Brief summary:

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.

Conditions

Breast Cancer

Cancer Survivor

Fatigue

Pain

Study ID

NCT00336089

Start date

Jan, 2006

Status verified date

Jul, 2009

Primary completion date

Dec, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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 Design

Enrollment

54 participants

Anticipated

Allocation

Randomized

Interventions and Outcome Measures

Interventions

exercise intervention

educational intervention

complementary or alternative medicine procedure

fatigue assessment and management

management of therapy complications

pain therapy

quality-of-life assessment

Central Contacts and Locations

Locations

Saint Joseph's Hospital of Atlanta

Recruiting

Atlanta, Georgia, United States, 30342-1701

Contacts

Clinical Trials Office - Saint Joseph's Hospital of Atlanta

404-851-7115

Clayton State University

Recruiting

Morrow, Georgia, United States, 30260-0285

Contacts

Melanie Poudevigne, PhD

678-466-4937mpoudevigne@clayton.edu

More Information

Sponsor

Clayton State University

Last update posted

Sep 17, 2013

Last verified

Jul, 2009

Keywords

  • 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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Clayton State University on 2013-09-17.