Breast Cancer Resiliency Through Exercise Program (B-REP)

Official title

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

Overview

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.

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]
• Feasibility of the exercise program (Adherence) [Time frame: 12 weeks after start of intervention]
• Feasibility of the exercise program (fidelity) [Time frame: 12 weeks after start of intervention]
• Satisfaction of program [Time frame: up to 24 weeks after start of intervention]
• Affective attitude [Time frame: up to 24 weeks after start of intervention]
• Perceived burden [Time frame: up to 24 weeks after start of intervention]
• Outcome expectation [Time frame: up to 24 weeks after start of intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• University of Michigan — Ann Arbor

Identifiers

NCT: NCT06100263 · UMCC 2023.092 · HUM00244376

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗