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A Pilot Study to Evaluate the Feasibility of a Breast Cancer Rehabilitation Program in Survivors of Breast Cancer

18 Years
Open (Enrolling)
Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer

Thank you

Trial Information

A Pilot Study to Evaluate the Feasibility of a Breast Cancer Rehabilitation Program in Survivors of Breast Cancer


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.


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.


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


- 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


- 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:


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:


Principal Investigator

Mara Vitolins

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wake Forest University


United States: Institutional Review Board

Study ID:

CCCWFU 99309



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



Wake Forest University Health Sciences Winston-Salem, North Carolina  27157