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

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Breast Cancer; Physical Activity

Treatments: Behavioral: Successful Survivorship Health Education and Support Group; Behavioral: Resistance Training - Fixed Schedule; Behavioral: Flexible support groups; Behavioral: Resistance Training - Flexible Schedule; Behavioral: Aerobic Training - Flexible Schedule; Behavioral: Aerobic Training - Fixed Schedule; Behavioral: Walking program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02763228

CASE2116

Details and patient eligibility

About

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.

Full 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.

Enrollment: 218 patients

Sex: Female

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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218 participants in 2 patient groups

Group 1: Exercise Program

Experimental group

Description:

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. Participants will be instructed in the exercise routine by physical fitness experts and trainers.

Treatment:

Behavioral: Resistance Training - Fixed Schedule

Behavioral: Resistance Training - Flexible Schedule

Behavioral: Aerobic Training - Flexible Schedule

Behavioral: Aerobic Training - Fixed Schedule

Behavioral: Walking program

Group 2: Support Group

Active Comparator group

Description:

First 20 Weeks: Participants will take part in a structured Health Education and Support Group sessions once a week. Last 32 weeks: Participants will be encouraged to take part in any of the Support Group sessions offered regularly on their own schedule.

Treatment:

Behavioral: Flexible support groups

Behavioral: Successful Survivorship Health Education and Support Group