Physical Activity Intervention to Reduce Functional Health Disparities Among Breast Cancer Survivors

Status:	Recruiting
Conditions:	Breast Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	65 - Any
Updated:	7/20/2018
Start Date:	March 16, 2016
End Date:	December 2019
Contact:	Cynthia Owusu, MD
Email:	cynthia.owusu@case.edu
Phone:	216-844-7670

A Physical Activity Intervention to Reduce Functional Health Disparities Among Older Breast Cancer Survivors

The purpose of this research study is to determine whether a physical activity (exercise)
program in the community will improve the functional and overall health status of older women
with a history of breast cancer. The physical activity or exercise program is designed for
all older breast cancer survivors, and in particular for African-Americans and women of lower
socio-economic status, who are the least likely to engage in physical activity.

Specific Aim #1: To determine the effect of a refined and culturally-sensitive physical
activity intervention on functional outcomes at 20 and 52 weeks among older Breast Cancer
survivors who are within five years of treatment completion for stage I-III Breast Cancer
(BCa).

Specific Aim #2: To examine whether race and socioeconomic status (SES) moderate the
intervention effect on physical activity (PA) levels and functional outcomes at 20 and 52
weeks.

Specific Aim #3: To examine the effect of the PA intervention on longitudinal changes in
beliefs, attitudes and preferences (KAPs) and PA levels, and the extent to which changes in
these factors mediate intervention effect on functional outcomes.

Specific Aim #4: To determine the effect of the PA intervention on surrogate biomarkers
associated with breast cancer prognosis and functional disability.

Inclusion Criteria:

- Pathologically confirmed breast cancer

- Stage I-III

- Patients who have completed treatment but are within five years of treatment
completion (primary surgery, chemotherapy or radiation therapy), whichever was
received last. Hormonal therapy and targeted therapy are allowed

- Race: African-Americans and Non-Hispanic Whites

Exclusion Criteria:

- Stage IV breast cancer

- Patients with end-stage disease, severe dementia and/or life expectancy of less than
one year

- Inability to understand English as study instruments have not been validated in other
languages

- Inability to provide informed consent

- High-risk patients (as defined by the American College of Sports Medicine
risk-stratification schema using the American College of Sports Medicine
(ACSM)/American Heart Association exercise pre-participation questionnaire) who do not
receive clearance from cardiology

- Other medical or psychological conditions that would make participation unsafe or
inhibit our ability to test our primary hypothesis, e.g. Parkinson's disease, severe
dementia.

We found this trial at

sites

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio 44195

Phone: 216-445-4624

from

Cleveland, OH