Breast Cancer FemaleB-REPNCT06100263
Breast Cancer Resiliency Through Exercise Program (B-REP)
A study testing Individualized exercise program in people with Breast Cancer Female, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Individualized exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Cancer AnswerLine, 800-865-1125, CancerAnswerLine@med.umich.edu
Angela Fong, PhD
About this study
Official title: 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
Read the 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.
- Conditions
- Breast Cancer Female
- Being tested
- Individualized exercise program, Control Arm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized exercise programOther
guided exercise program for 12 weeks
Control ArmOther
Control Arm Waiting List for 24 weeks, then offered a guided exercise program for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the exercise program (Retention)
Percent of patients that complete the intervention
Measured: up to 24 weeks after start of intervention
Feasibility of the exercise program (Adherence)
Percent of patients that complete the exercise sessions
Measured: 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..
Measured: 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.
Measured: up to 24 weeks after start of intervention
Affective attitude
36-item scale assessing views, attitude, and experiences in exercise87
Measured: 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.)
Measured: up to 24 weeks after start of intervention
Outcome expectation
15-item scale assessing physical, social, and self-evaluative outcomes of exercise
Measured: up to 24 weeks after start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start28 May 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela Fong, PhD, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100263
- Sponsor's protocol ID
- UMCC 2023.092
- Other IDs
- HUM00244376
- Acronym
- B-REP
- Status last verified
- Feb 2026
- First submitted
- 20 Oct 2023
- Last updated
- 10 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Resiliency Through Exercise Program (B-REP): Pilot Study
- ClinicalTrials.gov ID
- NCT06100263
- Acronym / sponsor ID
- B-REP / UMCC 2023.092
- Conditions
- Breast Cancer Female
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- 28 May 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (Supervised exercise) | Experimental | Other: Individualized exercise programThe 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. |
| Control (waitlist) | Active comparator | Other: Control ArmParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized exercise programguided exercise program for 12 weeks | Other | Intervention (Supervised exercise) |
| Control ArmControl Arm Waiting List for 24 weeks, then offered a guided exercise program for 12 weeks | Other | Control (waitlist) |
Primary outcome
Feasibility of the exercise program (Retention)
Time frame: up to 24 weeks after start of intervention
Percent of patients that complete the intervention
Feasibility of the exercise program (Adherence)
Time frame: 12 weeks after start of intervention
Percent of patients that complete the exercise sessions
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..
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.
Affective attitude
Time frame: up to 24 weeks after start of intervention
36-item scale assessing views, attitude, and experiences in exercise87
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.)
Outcome expectation
Time frame: up to 24 weeks after start of intervention
15-item scale assessing physical, social, and self-evaluative outcomes of exercise
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Angela Fong, PhD principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized exercise program in people with Breast Cancer Female, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer AnswerLine (1-800-865-1125, CancerAnswerLine@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the exercise program (Retention) (time frame: up to 24 weeks after start of intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.