Breast Cancer Resiliency Through Exercise Program (B-REP)

NCT ID: NCT06100263

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-28

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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14AUG2025- The sample size was updated, and the questionnaire was split into 2 questionnaires, as a planned solution in response to a low accrual

Conditions

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Breast Cancer Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention (Supervised exercise)

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.

Group Type EXPERIMENTAL

Individualized exercise program

Intervention Type OTHER

guided exercise program for 12 weeks

Control

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

Group Type ACTIVE_COMPARATOR

Control Arm

Intervention Type OTHER

American Cancer Society Physical Activity and the Person with Cancer summary for patients will be provided

Interventions

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Individualized exercise program

guided exercise program for 12 weeks

Intervention Type OTHER

Control Arm

American Cancer Society Physical Activity and the Person with Cancer summary for patients will be provided

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan Rogel Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angela Fong, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Cancer AnswerLine

Role: CONTACT

Phone: 1-800-865-1125

Email: [email protected]

Facility Contacts

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Cancer AnswerLine

Role: primary

Other Identifiers

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HUM00244376

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2023.092

Identifier Type: -

Identifier Source: org_study_id