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NCT Number: NCT06100263

Breast Cancer Resiliency Through Exercise Program (B-REP)

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

Recruiting

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Key information

Conditions

Breast Cancer Female

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Angela Fong, PhD

PRINCIPAL_INVESTIGATOR

Cancer AnswerLine

CONTACT

[email protected]

800-865-1125

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Individualized exercise program

Other

guided exercise program for 12 weeks

Control Arm

Other

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

Primary outcomes

  1. Feasibility of the exercise program (Retention)

    Time frame: up to 24 weeks after start of intervention

    Percent of patients that complete the intervention

  2. Feasibility of the exercise program (Adherence)

    Time frame: 12 weeks after start of intervention

    Percent of patients that complete the exercise sessions

  3. Feasibility of the exercise program (fidelity)

    Time frame: 12 weeks after start of intervention

    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..

  4. Satisfaction of program

    Time frame: up to 24 weeks after start of intervention

    14-item scale measuring ease of use, convenience, engagement, enjoyment, and privacy elements of the intervention.

  5. Affective attitude

    Time frame: up to 24 weeks after start of intervention

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

  6. Perceived burden

    Time frame: up to 24 weeks after start of intervention

    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.)

  7. Outcome expectation

    Time frame: up to 24 weeks after start of intervention

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

Study contacts

Contact information is provided by the study sponsor or research team.

Cancer AnswerLine

CONTACT

[email protected]

1-800-865-1125

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Registry information

Official study title

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

Acronym: B-REP

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 25, 2023
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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