A Pilot Study to Evaluate the Feasibility of a Breast Cancer Rehabilitation Program in Survivors of Breast Cancer
18 Years
N/A
Female
Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer
Trial Information
A Pilot Study to Evaluate the Feasibility of a Breast Cancer Rehabilitation Program in Survivors of Breast Cancer
PRIMARY OBJECTIVES:
I. To estimate accrual, retention, adherence, and participation of breast cancer survivors
to a breast cancer rehabilitation program.
II. To estimate the variability of weight, six-minute walk, quality of life and other
psychosocial and physical measures in women participating in the BCRP.
SECONDARY OBJECTIVES:
I. To assess changes in the anthropometric, psychosocial, and physical outcomes over the
six-month period of the BCRP.
II. To document the types and the rates of adverse events associated with the BCRP.
OUTLINE:
Patients attend exercise therapy sessions over 1 hour 3 times a week for 6 months. Exercise
therapy sessions are comprised of a 10 minute warm-up of light stretching and aerobic type
exercise (walking, cycling), 30 minutes of endurance type exercise (cycle, walking), and 20
minutes of resistance training exercise.
Inclusion Criteria
Inclusion
- First occurrence of breast cancer
- BMI >= 25
- Recently completed treatment(chemotherapy/radiation) for breast cancer (=< 8 weeks),
but can be receiving adjuvant hormonal therapy
- Willing to comply with study visits, as outlined in the protocol
- Lives within 30 miles of study site, or willing to travel to study site if outside a
30-mile radius
- Ability to participate in a moderate exercise program, such as freedom from any
orthopedic abnormalities that would prevent participation
- Ability to understand and the willingness to sign a written informed consent document
Exclusion
- Unstable angina
- Cardiac conduction disturbances
- Plans to move from the study area
- Dementia that is medically documented or suspected
- Advanced arterial disease causing ischemia of any limb
- Physical immobility
- Homebound for medical reasons
- Dependent on wheelchair for mobility
- Chronic disease which significantly reduces 4-year survival
- Recurrent breast cancer
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Ability to recruit breast cancer survivors into a six-month breast cancer rehabilitation program
Outcome Time Frame:
Approximately 24 months
Safety Issue:
No
Principal Investigator
Mara Vitolins
Investigator Role:
Principal Investigator
Investigator Affiliation:
Wake Forest University
Authority:
United States: Institutional Review Board
Study ID:
CCCWFU 99309
NCT ID:
NCT01113554
Start Date:
June 2010
Completion Date:
June 2013
Related Keywords:
- Stage I Breast Cancer
- Stage II Breast Cancer
- Stage IIIA Breast Cancer
- Stage IIIB Breast Cancer
- Stage IIIC Breast Cancer
- Stage IV Breast Cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
