Breast Cancer Resiliency Through Exercise Program (B-REP)
- Conditions
- Breast Cancer Female
- Interventions
- Other: Control ArmOther: Individualized exercise program
- Registration Number
- NCT06100263
- Lead Sponsor
- University of Michigan Rogel Cancer Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 200
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 I 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Control Arm 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 Intervention (Supervised exercise) Individualized exercise program 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.
- Primary Outcome Measures
Name Time Method Feasibility of the exercise program (Retention) up to 24 weeks after start of intervention Percent of patients that complete the intervention
Satisfaction of program up to 24 weeks after start of intervention 14-item scale measuring ease of use, convenience, engagement, enjoyment, and privacy elements of the intervention.
Affective attitude up to 24 weeks after start of intervention 36-item scale assessing views, attitude, and experiences in exercise87
Perceived burden up to 24 weeks after start of intervention 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.)
Feasibility of the exercise program (Adherence) 12 weeks after start of intervention Percent of patients that complete the exercise sessions
Feasibility of the exercise program (fidelity) 12 weeks after start of intervention 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..
Outcome expectation up to 24 weeks after start of intervention 15-item scale assessing physical, social, and self-evaluative outcomes of exercise
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States