Clinical trial · Interventional
Breast Cancer and Resistance Exercise Program
Breast Cancer and Resistance Exercise Program (B-REP): A Feasibility and Acceptability Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI left
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Resistance Training | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Online-delivered physical activity intervention. | Behavioral | — | UNRESOLVED |
| Printed, individualized resistance-based physical activity program. | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention arm
- description
- Participants will engage in 12, weekly, supervised, exercise sessions using Zoom with the exercise trainer. Once a week, the exercise trainer and participant will each log on to Zoom from their locations to begin the supervised exercise session. The exercise trainer will record all sessions. Sessions will be 30 to 45 minutes long and be structured as follows: review of previous session and an opportunity to ask questions; 5-minute warm-up; 20- to 25-minute workout; 5- to10-minute cool down and reminder of next session and/or data collection time period. Supervised sessions will be scheduled once a week over the 12-week intervention. Participants will be expected to complete their resistance-based physical activity program for an additional 1-2 days a week as per the intervention schedule to meet as physical activity guidelines. The exercise trainer will track participant attendance. During the session, participants must have another person in the same location in case of an emergency.
- interventionNames
- Behavioral: Online-delivered physical activity intervention.
- type
- OTHER
- label
- Control Arm
- description
- The attention control arm will include a printed, individualized resistance-based physical activity program. Participants randomized to the control arm will be given a printed or digital individualized, resistance-based physical activity program and told to aim to for three exercise sessions per week. Control participants will follow the same measurement schedule as intervention participants.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. aged 18 years and older 2. self-identify as Black or African American or Afro-Latina/e 3. a confirmed diagnosed of breast cancer \< 10 years prior to study start 4. does not have a concurrent cancer diagnosis 5. have completed active treatment \> 6 months prior to study commencement (hormonal therapy is acceptable) 6. who are inactive, defined as engaging in \< 30 minutes of moderate-to-vigorous physical activity per day for 3 days per week 7. are able to exercise safely as per physical activity safety screening questionnaire, Get Active Questionnaire 8. read and understand English h) have regular access to an internet-connected device with a video camera. Exclusion Criteria: 1. respiratory, joint, or cardiovascular problems precluding physical activity as per physical activity safety screening questionnaire 2. metastatic disease 3. planned elective surgery during the duration of the intervention and/or follow-up that would interfere with participation (e.g., breast reconstruction surgery) 4. does not have someone to supervise them while they exercised remotely.
References
Publications (9)
- BACKGROUNDRitterband LM, Bailey ET, Thorndike FP, Lord HR, Farrell-Carnahan L, Baum LD. Initial evaluation of an Internet intervention to improve the sleep of cancer survivors with insomnia. Psychooncology. 2012 Jul;21(7):695-705. doi: 10.1002/pon.1969. Epub 2011 Apr 29. PMID 21538678
- BACKGROUNDAmireault S, Godin G, Lacombe J, Sabiston CM. The use of the Godin-Shephard Leisure-Time Physical Activity Questionnaire in oncology research: a systematic review. BMC Med Res Methodol. 2015 Aug 12;15:60. doi: 10.1186/s12874-015-0045-7. PMID 26264621
- BACKGROUNDBrady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol. 1997 Mar;15(3):974-86. doi: 10.1200/JCO.1997.15.3.974. PMID 9060536
- BACKGROUNDResnick B, Jenkins LS. Testing the reliability and validity of the Self-Efficacy for Exercise scale. Nurs Res. 2000 May-Jun;49(3):154-9. doi: 10.1097/00006199-200005000-00007. PMID 10882320
- BACKGROUNDMcAuley E. Self-efficacy and the maintenance of exercise participation in older adults. J Behav Med. 1993 Feb;16(1):103-13. doi: 10.1007/BF00844757. PMID 8433355
- BACKGROUNDGet Active Questionnaire. Ottawa, Canada: Canadian Society of Exercise Physiology, 2016.
- BACKGROUNDHilgart M, Ritterband L, Baxter K, Alfano A, Ratliff C, Kinzie M, Cohn W, Whaley D, Lord H, Garber S. Development and perceived utility and impact of a skin care Internet intervention. Internet Interventions. 2014;1(3):149-57. doi: 10.1016/j.invent.2014.07.003; PMCID: PMC Journal - In Process.
- DERIVEDWakefield IL, Streubel O, Llanos AAM, Hudson SV, Schmitz K, Phillips SM, Manne SL, Henry NL, Resnicow K, Fong AJ. Evaluating an online-delivered resistance exercise intervention for racially diverse breast cancer survivors using the RE-AIM framework. Transl Behav Med. 2026 Jan 7;16(1):ibag019. doi: 10.1093/tbm/ibag019.