Breast Cancer Resiliency Through Exercise Program (B-REP)

University of Michigan Rogel Cancer Center

Status: Enrolling

Conditions: Breast Cancer Female

Treatments: Other: Control Arm; Other: Individualized exercise program

Study type: Interventional

Funder types: Other

Identifiers

NCT06100263

UMCC 2023.092

HUM00244376 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 75 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

Intervention (Supervised exercise)

Experimental group

Description:

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.

Treatment:

Other: Individualized exercise program

Control

Active Comparator group

Description:

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

Treatment:

Other: Control Arm