NCT02763228CompletedNot Applicable

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

Case Comprehensive Cancer Center3 sites in 1 country218 target enrollmentStarted: March 16, 2016Last updated: March 22, 2022

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Completed
Sponsor: Case Comprehensive Cancer Center
Enrollment: 218
Locations: 3
Primary Endpoint: Change in physical performance scores based on the Short Physical Performance Battery (SPPB)

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Supportive Care
Masking: None

Eligibility Criteria

Ages: 65 Years to — (Older Adult)
Sex: Female
Accepts Healthy Volunteers: No

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.

Arms & Interventions

Group 1: Exercise Program

Experimental

The exercise in this study will consist of two types of exercise training: resistance training and aerobic exercise. Resistance training is like "weight lifting" to improve strength and function. Participants will complete resistance training by using resistance machines and free weights. Aerobic exercise is exercise that intends to improve the cardiopulmonary or oxygen/lung and heart systems. It is often referred to as "cardio" exercise. Treadmill walking, stationary cycling sessions, and/or other exercises will be used for aerobic exercise.