Breast Cancer Resiliency Through Exercise Program (B-REP) (B-REP)

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

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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer Female
• Intervention / Treatment: Other: Individualized exercise program; Other: Control Arm

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.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cancer AnswerLine; Phone Number: 1-800-865-1125; Email: CancerAnswerLine@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Cancer AnswerLine; Phone Number: 800-865-1125; Email: CancerAnswerLine@med.umich.edu
      • Principal Investigator: Angela Fong, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention (Supervised exercise); The individualized program is based on participants' baseline 5-repetition maximum muscular strength assessment and is aligned with current cancer-specific exercise recommendations. The resistance program will follow the FITT principle (frequency, intensity, time, and type): Frequency. Participants will aim for 3 resistance exercise sessions per week. Intensity. Resistance exercise intensity will have a schedule for increased progression by both load via increased weight and volume via increased repetitions and sets. If participants are not able to increase resistance loads as scheduled, they will remain at their current load and volume until the next scheduled increase. 50% of 5-repetition maximum for upper and lower body. 3 sets of 8 to 12 repetitions. 60% of 5-repetition maximum for upper and lower body. 3 sets of 8 to 12 repetitions. 70% of 5-repetition maximum for upper and lower body. 4 sets of 8 to 12 repetitions.	Other: Individualized exercise program; guided exercise program for 12 weeks
Active Comparator: Control (waitlist); Participants randomized to the waitlist control condition will be on a waiting list for 24 weeks. Participants in waitlist control condition will complete measures on the same schedule as intervention participants. After 24 weeks, participants will be offered to participate in the online sessions with an exercise trainer using Zoom twice per week for 12- weeks. The sessions will be 30 to 45minutes in length.	Other: Control Arm; Control Arm Waiting List for 24 weeks, then offered a guided exercise program for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the exercise program (Retention)	Percent of patients that complete the intervention	up to 24 weeks after start of intervention
Feasibility of the exercise program (Adherence)	Percent of patients that complete the exercise sessions	12 weeks after start of intervention
Feasibility of the exercise program (fidelity)	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..	12 weeks after start of intervention
Satisfaction of program	14-item scale measuring ease of use, convenience, engagement, enjoyment, and privacy elements of the intervention.	up to 24 weeks after start of intervention
Affective attitude	36-item scale assessing views, attitude, and experiences in exercise87	up to 24 weeks after start of intervention
Perceived burden	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.)	up to 24 weeks after start of intervention
Outcome expectation	15-item scale assessing physical, social, and self-evaluative outcomes of exercise	up to 24 weeks after start of intervention

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Investigators: Principal Investigator: Angela Fong, PhD, University of Michigan Rogel Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: October 20, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: UMCC 2023.092; HUM00244376 (Other Identifier: University of Michigan)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No