Breast Cancer Resiliency Through Exercise Program (B-REP)
ConditionBreast Cancer Female
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Michigan Rogel Cancer Center
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Individualized exercise program
Other interventionguided exercise program for 12 weeks
Control Arm
Other interventionControl Arm Waiting List for 24 weeks, then offered a guided exercise program for 12 weeks
Treatment groups
75 Participants
are divided into 2 treatment groupsGroup A: Intervention (Supervised exercise)Experimental treatment 1 intervention
Group B: Control (waitlist)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of the exercise program (Retention)
Percent of patients that complete the intervention
Time frame
up to 24 weeks after start of intervention2
Feasibility of the exercise program (Adherence)
Percent of patients that complete the exercise sessions
Time frame
12 weeks after start of intervention3
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..
Time frame
12 weeks after start of intervention4
Satisfaction of program
14-item scale measuring ease of use, convenience, engagement, enjoyment, and privacy elements of the intervention.
Time frame
up to 24 weeks after start of interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov