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NCT06100263NARecruiting

Breast Cancer Resiliency Through Exercise Program (B-REP)

University of Michigan Rogel Cancer Center

Start Date

5/28/2024

Completion Date

12/1/2026

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

OTHER

Individualized exercise program

OTHER

Control Arm

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Conditions

Breast Cancer Female

Locations

University of Michigan

Ann Arbor, Michigan 48109

United States