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Breast Cancer Resiliency Through Exercise Program (B-REP)

Sponsor
University of Michigan Rogel Cancer Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06100263
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
30
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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 a health education control among 60 Black breast cancer survivors.

Condition or Disease Intervention/Treatment Phase
  • Other: Individualized exercise program
  • Other: Control Arm
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Breast Cancer Resiliency Through Exercise Program (B-REP): Pilot Study
Anticipated Study Start Date :
Apr 1, 2024
Anticipated Primary Completion Date :
Oct 1, 2026
Anticipated Study Completion Date :
Oct 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention (Supervised exercise)

The individualized resistance exercise program is based on participants' baseline 1-repetition maximum muscular strength assessment (i.e., the maximum lifted for 1 repetition) and is aligned with current cancer-specific exercise recommendations. The resistance exercise program will follow the FITT principle (frequency, intensity, time, and type). Sessions will be 35-45 minutes in duration.

Other: Individualized exercise program
guided exercise program for 12 weeks
Active Comparator: Control

Participants randomized to health education control condition will receive the American Cancer Society Physical Activity and the Person with Cancer summary for patients and American College of Sports Medicine Exercise is Medicine Effects of Exercise on Health-Related Outcomes in Those with Cancer infographic

Other: Control Arm
American Cancer Society Physical Activity and the Person with Cancer summary for patients will be provided

Outcome Measures

Primary Outcome Measures

  1. Feasibility of the exercise program (Retention) [up to 24 weeks after start of intervention]

    Percent of patients that complete the intervention

  2. Feasibility of the exercise program (Adherence) [12 weeks after start of intervention]

    Percent of patients that complete the exercise sessions

  3. Feasibility of the exercise program (fidelity) [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 [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 [up to 24 weeks after start of intervention]

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

  6. Perceived burden [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 [up to 24 weeks after start of intervention]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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 0I 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Michigan Ann Arbor Michigan United States 48109

Sponsors and Collaborators

  • University of Michigan Rogel Cancer Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier:
NCT06100263
Other Study ID Numbers:
  • UMCC 2023.092
First Posted:
Oct 25, 2023
Last Update Posted:
Oct 25, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Oct 25, 2023