NCT06100263 · University of Michigan Rogel Cancer Center
Breast Cancer Resiliency Through Exercise Program (B-REP)
(B-REP)
What this study is about
The study will use a cross-sectional study design with a follow-up 2-treatment group$1 randomly assigned controlled trial with that has assessments at baseline, post-intervention (i.e., Week 12), and 3-months post-intervention (i.e., Week 24).
View original scientific description
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).
Interventions
OTHER
Individualized exercise program
guided exercise program for 12 weeks
OTHER
Control Arm
Control Arm Waiting List for 24 weeks, then offered a guided exercise program for 12 weeks
Primary outcome measures
Feasibility of the exercise program (Retention)
Time frame: up to 24 weeks after start of intervention
Percent of patients that complete the intervention
Feasibility of the exercise program (Adherence)
Time frame: 12 weeks after start of intervention
Percent of patients that complete the exercise sessions
Feasibility of the exercise program (fidelity)
Time frame: 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..
Satisfaction of program
Time frame: 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
Time frame: up to 24 weeks after start of intervention
36-item scale assessing views, attitude, and experiences in exercise87
Perceived burden
Time frame: 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.)
Outcome expectation
Time frame: up to 24 weeks after start of intervention
15-item scale assessing physical, social, and self-evaluative outcomes of exercise
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 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.
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.
Where
- Ann Arbor, Michigan
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 10, 2026 · Source of record for eligibility and locations