NCT04562233: B-REP

Breast Cancer and Resistance Exercise Program

Terminated NA Last updated 13 October 2023

What this trial tests

NA trial testing Online-delivered physical activity intervention. in Breast Cancer in 56 participants. Terminated before completion.

Timeline

1 December 2020

Primary endpoint
24 August 2023

24 August 2023

Quick facts

Lead sponsor	Rutgers, The State University of New Jersey
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	56
Start date	1 December 2020
Primary completion	24 August 2023
Estimated completion	24 August 2023
Sites	1 location across United States

Drugs / interventions tested

• Online-delivered physical activity intervention.
• Printed, individualized resistance-based physical activity program.

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →
• Resistance Training — all drugs for Resistance Training →

Sponsor

Rutgers, The State University of New Jersey

Who can join

18 and older, female only, with Breast Cancer or Resistance Training. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of the study is to test the feasibility and acceptability of a supervised, online-delivered, individualized, physical activity program in a sample of post-active treatment breast cancer survivors. The proposed intervention will use a 2-arm randomized controlled trial study design to compare a 12-week resistance-based physical activity program to an attention control (i.e., printed individualized physical activity program) group on feasibility, acceptability and changes in strength as measured by 10 repetition maximum (10RM). Both groups will wear accelerometers. The main hypothesis is that participants randomized to the intervention arm will rate the online-delivered physical activity program as feasible and acceptable compared to attention control participants. The overall rationale is that delivering a physical activity intervention online may increase uptake of the intervention, which may lead to maintained physical activity behavior and associated health benefits. The primary outcomes are feasibility as measured by participant retention and acceptability as measured by adherence to physical activity program (recorded by physical activity log). Secondary outcomes include changes in strength as measured by 10RM, objectively measured physical activity levels as measured by the accelerometer, satisfaction, physical functioning and health-related quality of life. Additionally, a select number of participants will be invited for an interview to talk about their experiences in the program, motivation and barriers to exercise.

Interview description: Participants will complete one-on-one interviews with the PI or research staff over videoconferencing software (Rutgers Zoom). The interview will be 45 to 60 minutes in duration and audio recorded using the "record meeting" function. Prior to the interview, participants will consent to being audio recorded. The recording will be stored on Box (a HIPAA compliant cloud drive). A transcript of the audio will be generated using the "audio transcript" function on Rutgers Zoom and transcribed by a third party to ensure accuracy.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Online-delivered resistance exercise intervention among racially diverse breast cancer survivors: Feasibility, acceptability, and exploratory outcomes of B-REP.
   Fong AJ, Llanos AAM, Hudson SV, Schmitz K, et al · · 2024 · cited 2× · PMID 39090218 · DOI 10.1007/s00520-024-08769-9
2. Evaluating an online-delivered resistance exercise intervention for racially diverse breast cancer survivors using the RE-AIM framework.
   Wakefield IL, Streubel O, Llanos AAM, Hudson SV, et al · · 2026 · PMID 41990365 · DOI 10.1093/tbm/ibag019