Breast Cancer Resiliency Through Exercise Program (B-REP)

Study Overview
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Brief Summary
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The study will use a cross-sectional study design with a follow-up 2-arm randomized controlled trial with that has assessments at baseline, post-intervention (i.e., Week 12), and 3-months post-intervention (i.e., Week 24). The 2 arms are the 12-week intervention and a health education control among 60 Black breast cancer survivors.

Official Title
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Breast Cancer Resiliency Through Exercise Program (B-REP): Pilot Study

Conditions
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Breast Cancer Female

Intervention / Treatment
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* Other: Individualized exercise program
* Other: Control Arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women will be eligible if they meet the following criteria: self-identify as Black or African American or Afro-Latina/e; are ≥18 years old; have a confirmed diagnosis of breast cancer, Stage 0I to IIIA; have completed primary active treatment (i.e., surgery, chemotherapy, and radiation) within 5 years prior to study start where concomitant hormonal therapy is acceptable; are not meeting current cancer-specific resistance exercise guidelines of ≥ 2 times per week; and are able to speak and understand English. Exclusion Criteria: metastatic disease; medical reason that precludes them from increasing current exercise levels; planned elective surgery during study period; pregnant or plans to become pregnant during the study period; plans to move out of United States during the study period; (the rationale for this exclusion is that it will be difficult to conduct the in-person assessments if a participant leaves the United States); current enrollment in another exercise trial; and/or inability to pass exercise pre-screening or receive physician consent to increase current physical activity levels.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention (Supervised exercise)<br>The individualized resistance exercise program is based on participants' baseline 1-repetition maximum muscular strength assessment (i.e., the maximum lifted for 1 repetition) and is aligned with current cancer-specific exercise recommendations. The resistance exercise program will follow the FITT principle (frequency, intensity, time, and type). Sessions will be 35-45 minutes in duration. | Other: Individualized exercise program<br>* guided exercise program for 12 weeks<br>|
| Active Comparator: Control<br>Participants randomized to health education control condition will receive the American Cancer Society Physical Activity and the Person with Cancer summary for patients and American College of Sports Medicine Exercise is Medicine Effects of Exercise on Health-Related Outcomes in Those with Cancer infographic | Other: Control Arm<br>* American Cancer Society Physical Activity and the Person with Cancer summary for patients will be provided<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the exercise program (Retention) | Percent of patients that complete the intervention | up to 24 weeks after start of intervention | 
| Feasibility of the exercise program (Adherence) | Percent of patients that complete the exercise sessions | 12 weeks after start of intervention | 
| Feasibility of the exercise program (fidelity) | Upon completion of the trial, a random sample of 10 recorded sessions will be analyzed for fidelity. Research staff who did not conduct the intervention will use a fidelity checklist of specific exercises and intervention characteristics (e.g., allowing time for questions, cueing for proper posture and form, etc.) required for each exercise session.. | 12 weeks after start of intervention | 
| Satisfaction of program | 14-item scale measuring ease of use, convenience, engagement, enjoyment, and privacy elements of the intervention. | up to 24 weeks after start of intervention | 
| Affective attitude | 36-item scale assessing views, attitude, and experiences in exercise87 | up to 24 weeks after start of intervention | 
| Perceived burden | Single item, Now that you've completed this part of the study, how burdensome or difficult did you find the experience. Select the response that best represents your experience. (1= Very burdensome to 5= Not too burdensome.) | up to 24 weeks after start of intervention | 
| Outcome expectation | 15-item scale assessing physical, social, and self-evaluative outcomes of exercise | up to 24 weeks after start of intervention |