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

NCT ID: NCT06100263Sponsor: University of Michigan Rogel Cancer CenterLast updated: 2026-02-10

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 waitlist control among 30 Black breast cancer survivors

Detailed description

14AUG2025- The sample size was updated, and the questionnaire was split into 2 questionnaires, as a planned solution in response to a low accrual 28OCT2025- Amendment was processed to update design and intervention items. The exercise threshold was changed from a 1-repeition maximum (1RM) to a 5-repeptition maximum (5RM). Since the intervention includes functional exercises, so we elected to use a functional strength (5RM) outcome rather than a maximal strength outcome (1RM) to better align with the intervention. The control condition was changed to a waitlist design. A waitlist control is more engaging, and there is a higher likelihood of retaining control participants.

Arms & interventions

  • OtherIndividualized exercise program

    guided exercise program for 12 weeks

  • OtherControl Arm

    Control Arm Waiting List for 24 weeks, then offered a guided exercise program for 12 weeks

Outcome measures

Primary

  • Feasibility of the exercise program (Retention)

    Percent of patients that complete the intervention

    Time frame: up to 24 weeks after start of intervention

  • Feasibility of the exercise program (Adherence)

    Percent of patients that complete the exercise sessions

    Time frame: 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..

    Time frame: 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.

    Time frame: up to 24 weeks after start of intervention

  • Affective attitude

    36-item scale assessing views, attitude, and experiences in exercise87

    Time frame: 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.)

    Time frame: up to 24 weeks after start of intervention

  • Outcome expectation

    15-item scale assessing physical, social, and self-evaluative outcomes of exercise

    Time frame: up to 24 weeks after start of intervention

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (1)

University of Michigan

Ann Arbor, Michigan, 48109

Recruiting
Cancer AnswerLine · Contact
800-865-1125CancerAnswerLine@med.umich.edu
Angela Fong, PhD · Principal Investigator
Breast Cancer Resiliency Through Exercise Program (B-REP) | Cancerify