Breast Cancer Rehabilitation Program in Improving Quality of Life in Breast Cancer Survivors

Wake Forest University (WFU)

Status: Completed

Conditions: Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage II Breast Cancer; Stage I Breast Cancer; Stage IV Breast Cancer

Treatments: Other: questionnaire administration; Procedure: management of therapy complications; Other: survey administration; Procedure: psychosocial assessment and care; Procedure: quality-of-life assessment; Behavioral: exercise intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01113554

CCCWFU 99309 (Other Identifier)

NCI-2010-00975

IRB00012783

Details and patient eligibility

About

RATIONALE: A breast cancer rehabilitation program and exercise therapy may help improve the quality of life of breast cancer survivors.

PURPOSE: This clinical trial studies a breast cancer rehabilitation program in improving quality of life in breast cancer survivors.

Full description

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.

Enrollment: 26 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

26 participants in 1 patient group

Arm I

Experimental group

Description:

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.

Treatment:

Procedure: quality-of-life assessment

Procedure: psychosocial assessment and care

Other: questionnaire administration

Procedure: management of therapy complications

Behavioral: exercise intervention

Other: survey administration