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


N/A
18 Years
N/A
Open (Enrolling)
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

Thank you

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 SciencesWinston-Salem, North Carolina  27157