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

Not Applicable

Completed

• Conditions: Breast Cancer; Physical Activity
• Interventions: Behavioral: Aerobic Training - Fixed Schedule; Behavioral: Successful Survivorship Health Education and Support Group; Behavioral: Resistance Training - Fixed Schedule; Behavioral: Flexible support groups; Behavioral: Walking program; Behavioral: Aerobic Training - Flexible Schedule; Behavioral: Resistance Training - Flexible Schedule

• Registration Number: NCT02763228
• Lead Sponsor: Case Comprehensive Cancer Center

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 Timeline

• Study Start: 2016-03-16
• Study First Submitted: 2016-04-27
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-05
• Primary Completion: 2020-03-25
• Study Completion: 2020-11-06
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 218

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Exercise Program	Aerobic Training - Fixed Schedule	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.
Group 1: Exercise Program	Resistance Training - Fixed Schedule	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.
Group 1: Exercise Program	Walking program	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.
Group 1: Exercise Program	Aerobic Training - Flexible Schedule	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.
Group 1: Exercise Program	Resistance Training - Flexible Schedule	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.
Group 2: Support Group	Successful Survivorship Health Education and Support Group	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.
Group 2: Support Group	Flexible support groups	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.

Primary Outcome Measures

Name	Time	Method
Change in physical performance scores based on the Short Physical Performance Battery (SPPB)	baseline to 20 weeks	Change in physical performance will be ascertained using the Short Physical Performance Battery (SPPB). Summary scores range from 0-12 and higher scores denote higher physical performance.

Secondary Outcome Measures

Name	Time	Method
Change in SPPB scores	baseline to 52 weeks	Change in physical performance will be ascertained using the Short Physical Performance Battery (SPPB). Summary scores range from 0-12 and higher scores denote higher physical performance.
Change in Activities of daily living (ADL) score	baseline to 52 weeks	Summary scores for ADL range from 0-14 and higher scores denote higher functional status.

Trial Locations

Locations (3)

Metro Health Medical Center; 🇺🇸 Cleveland, Ohio, United States

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States