Recruiting

B-REP

Sponsor:

University of Michigan Rogel Cancer Center

Code:

NCT06100263

Conditions

Breast Cancer Female

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Individualized exercise program

Control Arm

Study Details

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

Study ID

NCT06100263

Start date

May 28, 2024

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Individualized exercise program

guided exercise program for 12 weeks

Control Arm

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

Primary outcome measure

  • Feasibility of the exercise program (Retention) [ Time Frame: up to 24 weeks after start of intervention ]
  • Feasibility of the exercise program (Adherence) [ Time Frame: 12 weeks after start of intervention ]
  • Feasibility of the exercise program (fidelity) [ Time Frame: 12 weeks after start of intervention ]
  • Satisfaction of program [ Time Frame: up to 24 weeks after start of intervention ]
  • Affective attitude [ Time Frame: up to 24 weeks after start of intervention ]
  • Perceived burden [ Time Frame: up to 24 weeks after start of intervention ]
  • Outcome expectation [ Time Frame: up to 24 weeks after start of intervention ]

Central Contacts and Locations

Central contacts

Cancer AnswerLine

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

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Cancer AnswerLine

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

Principal Investigator:

Angela Fong, PhD

More Information

Sponsor

University of Michigan Rogel Cancer Center

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan Rogel Cancer Center on 2026-02-10.