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Online-delivered physical activity intervention. for Breast Cancer (B-REP Trial)

N/A

Waitlist Available

Led By Angela Fong, PhD

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up prior to intervention start and following the week 12 and week 24 assessments

Awards & highlights

B-REP Trial Summary

This trial is testing the feasibility and acceptability of a supervised, online physical activity program for breast cancer survivors. The goal is to see if the program is feasible and acceptable, and if it leads to increased strength and physical activity.

Eligible Conditions

Breast Cancer
Resistance Training

B-REP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ prior to intervention start and following the week 12 and week 24 assessments

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~prior to intervention start and following the week 12 and week 24 assessments

This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to intervention start and following the week 12 and week 24 assessments for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability (program adherence)

Feasibility (participant retention)

Internet Evaluation and Utility Questionnaire

Secondary outcome measures

10 Repetition Maximum Test

Accelerometer (ActiGraph)

Barrier Self-Efficacy Questionnaire

+4 more

B-REP Trial Design

2Treatment groups

Experimental Treatment

Group I: Intervention armExperimental Treatment1 Intervention

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.

Group II: Control ArmExperimental Treatment1 Intervention

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.

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Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor

429 Previous Clinical Trials

64,176 Total Patients Enrolled

15 Trials studying Breast Cancer

1,854 Patients Enrolled for Breast Cancer

Angela Fong, PhDPrincipal InvestigatorRutgers, The State University of New Jersey

1 Previous Clinical Trials

60 Total Patients Enrolled

Media Library

Online-delivered physical activity intervention Clinical Trial Eligibility Overview. Trial Name: NCT04562233 — N/A

Breast Cancer Research Study Groups: Control Arm, Intervention arm

Breast Cancer Clinical Trial 2023: Online-delivered physical activity intervention Highlights & Side Effects. Trial Name: NCT04562233 — N/A

Online-delivered physical activity intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04562233 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current openings for this research endeavor?

"According to the information available on clinicaltrials.gov, this study is open for recruitment and was first announced in December 2020 with a recent update occurring in November 2022."

Answered by AI

What is the scope of recruitment for this clinical trial?

"Correct. Records posted on clinicaltrials.gov verify that this study, which was first uploaded on December 1st 2020, is currently recruiting patients. This research requires 50 participants to be assigned from a single site."

Answered by AI

What is the chief goal of this trial?

"This clinical trial aspires to gauge the acceptability of the program over a 12-week period, via follow-up questionnaires for intervention arm participants. As secondary objectives, this study will also measure Barrier Self-Efficacy using a 0%-100% scale; Functional Assessment of Cancer Therapy - Breast cancer with responses ranging from 'not at all' to 'very much'; and Accelerometer (ActiGraph) data regarding physical activity intensity and duration."

Answered by AI

Recent research and studies

BMC Medical Research MethodologyJournal

The Use of the Godin-shephard Leisure-time Physical Activity Questionnaire in Oncology Research: A Systematic Review

Amireault, Steve, Gaston Godin, Jason Lacombe, and Catherine M. Sabiston. 2015. “The Use of the Godin-shephard Leisure-time Physical Activity Questionnaire in Oncology Research: A Systematic Review”. BMC Medical Research Methodology. Springer Science and Business Media LLC. doi:10.1186/s12874-015-0045-7.

Nursing ResearchJournal

Testing the Reliability and Validity of the Self-efficacy for Exercise Scale

Resnick, Barbara, and Louise S. Jenkins. 2000. “Testing the Reliability and Validity of the Self-efficacy for Exercise Scale”. Nursing Research. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00006199-200005000-00007.

Journal of Clinical OncologyJournal

Reliability and Validity of the Functional Assessment of Cancer Therapy-breast Quality-of-life Instrument.

Brady, M J, D F Cella, F Mo, A E Bonomi, D S Tulsky, S R Lloyd, S Deasy, M Cobleigh, and G Shiomoto. 1997. “Reliability and Validity of the Functional Assessment of Cancer Therapy-breast Quality-of-life Instrument.”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.1997.15.3.974.

Journal of Behavioral MedicineJournal