Breast Cancer Resiliency Through Exercise Program (B-REP)

NCT06100263 | Recruiting

• 2 other identifiers: UMCC 2023.092HUM00244376
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Intervention (Supervised exercise)

EXPERIMENTAL

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

Control (waitlist)

ACTIVE COMPARATOR

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

Interventions

Individualized exercise program OTHER

guided exercise program for 12 weeks

Intervention (Supervised exercise)

Control Arm OTHER

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

Control (waitlist)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• current enrollment in another exercise trial; and/or
• inability to pass exercise pre-screening or receive physician consent to increase current physical activity levels.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Study Officials

• Angela Fong, PhD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cancer AnswerLine

CONTACT

1-800-865-1125; CancerAnswerLine@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 25, 2023
• Study Start: May 28, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)