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Trial Title:
Breast Cancer Resiliency Through Exercise Program (B-REP)
NCT ID:
NCT06100263
Condition:
Breast Cancer Female
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Individualized exercise program
Description:
guided exercise program for 12 weeks
Arm group label:
Intervention (Supervised exercise)
Intervention type:
Other
Intervention name:
Control Arm
Description:
American Cancer Society Physical Activity and the Person with Cancer summary for patients
will be provided
Arm group label:
Control
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Michigan
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cancer AnswerLine
Phone:
800-865-1125
Email:
CancerAnswerLine@med.umich.edu
Investigator:
Last name:
Angela Fong, PhD
Email:
Principal Investigator
Start date:
May 28, 2024
Completion date:
December 2026
Lead sponsor:
Agency:
University of Michigan Rogel Cancer Center
Agency class:
Other
Source:
University of Michigan Rogel Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06100263
