Breast CancerB-REPNCT04562233
Breast Cancer and Resistance Exercise Program
A study testing Online-delivered physical activity intervention. and Printed, individualized resistance-based physical activity program. in people with Breast Cancer and Resistance Training, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Resistance Training
- What is being tested?
- Online-delivered physical activity intervention. and Printed, individualized resistance-based physical activity program.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 24 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18 years and older
- self-identify as Black or African American or Afro-Latina/e
- a confirmed diagnosed of breast cancer < 10 years prior to study start
- does not have a concurrent cancer diagnosis
- have completed active treatment > 6 months prior to study commencement (hormonal therapy is acceptable)
- who are inactive, defined as engaging in < 30 minutes of moderate-to-vigorous physical activity per day for 3 days per week
Show all 9Show fewer
- are able to exercise safely as per physical activity safety screening questionnaire, Get Active Questionnaire
- read and understand English
- have regular access to an internet-connected device with a video camera.
Who cannot join
- respiratory, joint, or cardiovascular problems precluding physical activity as per physical activity safety screening questionnaire
- metastatic disease
- planned elective surgery during the duration of the intervention and/or follow-up that would interfere with participation (e.g., breast reconstruction surgery)
- does not have someone to supervise them while they exercised remotely.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
About this study
Official title: Breast Cancer and Resistance Exercise Program (B-REP): A Feasibility and Acceptability Trial
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.
Read the detailed description
The project will use a 2-arm randomized controlled trial study. The intervention will include a 12, weekly, supervised, online-delivered, individualized resistance-based exercise program. The attention control arm will include a printed, individualized resistance-based physical activity program. A total of 50 breast cancer survivors will be recruited from Rutgers Cancer Institute of New Jersey (CINJ) and randomized to one of two study arms. The intervention arm will test the feasibility and acceptability of the intervention compared to the control arm, which will receive a printed or digital copy of an individualized physical activity program. Participants from both arms will receive an accelerometer (ActiGraph GT3X+), resistance bands (TheraBand®), and additional free weights (if required). Outcome measures will be assessed at baseline (pre-intervention), Week 12 (post-intervention) and Week 24 (follow-up). Data collection will occur both in-person and online. Data will be both objective (10RM, functional strength, physical activity measured by accelerometers, physical function assessments, and attendance) and subjective (self-reported physical activity program adherence, satisfaction, physical activity levels, health-related quality of life, and exercise and barrier self-efficacy).
Additionally, 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 participants will be asked to discuss their experiences in the program.
- Conditions
- Breast Cancer, Resistance Training
- Being tested
- Online-delivered physical activity intervention., Printed, individualized resistance-based physical activity program.
- Keywords
- online, breast cancer, physical activity, breast neoplasm, resistance exercise, survivor
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online-delivered physical activity intervention.Behavioural
Participants randomized to the intervention arm will engage in 12, weekly, supervised, exercise sessions using Zoom with the exercise trainer.
Printed, individualized resistance-based physical activity program.Behavioural
Without the supervision of an exercise trainer, participants will be given a printed, individualized resistance-based physical activity program to complete over the course of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | 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. Receives: Behavioral: Online-delivered physical activity intervention. |
| Control Arm | Other | 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. Receives: Behavioral: Printed, individualized resistance-based physical activity program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (participant retention)
Participant retention at assessment timepoints (attendance and completing assessments)
Measured: 14 weeks including pre-intervention and post-intervention questionnaire completion
Acceptability (program adherence)
Adherence to physical activity program/intervention (attendance and exercise logs)
Measured: 12 weeks to complete the intervention
Internet Evaluation and Utility Questionnaire
Satisfaction will be measured as participants' experience and perceptions of an internet intervention. Scale values: Not at all, slightly, somewhat, mostly \& very. Higher scores are associated with a greater level of satisfaction.
Measured: After the 12 week intervention and captured in follow-up questionnaire for intervention arm participants
Secondary outcomes (7)
10 Repetition Maximum Test
Changes in strength measured by 10RM assessment
Measured: During the baseline assessment, week 12 assessment and week 24 follow up assessment
Godin Leisure Time Exercise Questionnaire
Self-report exercise frequency (times per week) and intensity (mild, moderate, and vigorous). Higher scores indicate that individuals are more active.
Measured: During the baseline assessment, week 12 assessment and week 24 follow up assessment
Accelerometer (ActiGraph)
Objective measure of total physical activity levels with intensity and duration (minutes). No scale.
Measured: Prior to intervention start and following the Week 12 and week 24 assessments
Senior Fitness Test
Functional assessments including senior fitness test, which includes the 6 minute walk test, chair sit to stand test and arm curl test. Scores are compared to age-matched, national averages.
Measured: During the baseline assessment, week 12 assessment and week 24 follow up assessment
Exercise Self-Efficacy Questionnaire
Confidence to exercise over the next three months rated on a scale of 0% to 100% confidence. High scores indicate higher perceived confidence to exercise.
Measured: During the baseline assessment, week 12 assessment and week 24 follow up assessment
Barrier Self-Efficacy Questionnaire
Confidence to overcome commonly-reported barriers rated on a scale of 0% to 100%. Higher scores indicated higher perceived confidence to overcome barriers.
Measured: During the baseline assessment, week 12 assessment and week 24 follow up assessment
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Scale measures physical wellbeing, social/family wellbeing, emotional wellbeing and functional wellbeing with items specifically for breast cancer (additional concerns). Scale - Not at all, a little bit, some-what, quite a bit, very much. Higher scores indicate better outcomes.
Measured: Completed at baseline assessment, after completion of the intervention at week 12 and at the week 24 follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start1 Dec 2020
- Primary completion24 Aug 2023
- Study completion24 Aug 2023
Why it stopped: PI left
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CINJRegulatory, Rutgers, The State University of New Jersey
- Investigators
- Angela Fong, PhD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562233
- Sponsor's protocol ID
- Pro2020002182
- Other IDs
- Pro2020002182, 132012
- Acronym
- B-REP
- Status last verified
- Oct 2023
- First submitted
- 18 Sep 2020
- Last updated
- 13 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual data that underlie results will be shared after de-identification for analysis purposes. Data sources include: 1) clinical and physical assessment data collected at the CINJ, 2) patient-reported questionnaire data collected through REDCap in a personal device or study-specific iPad, 3) observational data collected from recording one-on-one exercise sessions, and 4) Interview audio from zoom and transcribed interviews The final dataset will not contain any information that could identify individuals. Data will be shared using secure, Rutgers email between the PI and Co-Is.
Publications
Ritterband 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.
PubMed 21538678Amireault 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.
PubMed 26264621Brady 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.
PubMed 9060536Resnick 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.
PubMed 10882320McAuley 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.
PubMed 8433355Get Active Questionnaire. Ottawa, Canada: Canadian Society of Exercise Physiology, 2016.
Hilgart 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.
Wakefield 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.
PubMed 41990365Fong AJ, Llanos AAM, Hudson SV, Schmitz K, Lu SE, Phillips SM, Manne SL. Online-delivered resistance exercise intervention among racially diverse breast cancer survivors: Feasibility, acceptability, and exploratory outcomes of B-REP. Support Care Cancer. 2024 Aug 1;32(8):565. doi: 10.1007/s00520-024-08769-9.
PubMed 39090218
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer and Resistance Exercise Program (B-REP): A Feasibility and Acceptability Trial
- ClinicalTrials.gov ID
- NCT04562233
- Acronym / sponsor ID
- B-REP / Pro2020002182
- Conditions
- Breast Cancer, Resistance Training
- Keywords
- online, breast cancer, physical activity, breast neoplasm, resistance exercise, survivor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 24 Aug 2023 (actual)
- Study completion
- 24 Aug 2023 (actual)
- First posted
- 24 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The project will use a 2-arm randomized controlled trial study. The intervention will include a 12, weekly, supervised, online-delivered, individualized resistance-based exercise program. The attention control arm will include a printed, individualized resistance-based physical activity program. A total of 50 breast cancer survivors will be recruited from Rutgers Cancer Institute of New Jersey (CINJ) and randomized to one of two study arms. The intervention arm will test the feasibility and acceptability of the intervention compared to the control arm, which will receive a printed or digital copy of an individualized physical activity program. Participants from both arms will receive an accelerometer (ActiGraph GT3X+), resistance bands (TheraBand®), and additional free weights (if required). Outcome measures will be assessed at baseline (pre-intervention), Week 12 (post-intervention) and Week 24 (follow-up). Data collection will occur both in-person and online. Data will be both objective (10RM, functional strength, physical activity measured by accelerometers, physical function assessments, and attendance) and subjective (self-reported physical activity program adherence, satisfaction, physical activity levels, health-related quality of life, and exercise and barrier self-efficacy).
Additionally, 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 participants will be asked to discuss their experiences in the program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Online-delivered physical activity 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. |
| Control Arm | Other | Behavioral: Printed, individualized resistance-based physical activity program.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- aged 18 years and older
- self-identify as Black or African American or Afro-Latina/e
- a confirmed diagnosed of breast cancer < 10 years prior to study start
- does not have a concurrent cancer diagnosis
- have completed active treatment > 6 months prior to study commencement (hormonal therapy is acceptable)
Key exclusion criteria (4 listed)
- respiratory, joint, or cardiovascular problems precluding physical activity as per physical activity safety screening questionnaire
- metastatic disease
- planned elective surgery during the duration of the intervention and/or follow-up that would interfere with participation (e.g., breast reconstruction surgery)
- does not have someone to supervise them while they exercised remotely.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online-delivered physical activity intervention.Participants randomized to the intervention arm will engage in 12, weekly, supervised, exercise sessions using Zoom with the exercise trainer. | Behavioural | Intervention arm |
| Printed, individualized resistance-based physical activity program.Without the supervision of an exercise trainer, participants will be given a printed, individualized resistance-based physical activity program to complete over the course of 12 weeks. | Behavioural | Control Arm |
Primary outcome
Feasibility (participant retention)
Time frame: 14 weeks including pre-intervention and post-intervention questionnaire completion
Participant retention at assessment timepoints (attendance and completing assessments)
Acceptability (program adherence)
Time frame: 12 weeks to complete the intervention
Adherence to physical activity program/intervention (attendance and exercise logs)
Internet Evaluation and Utility Questionnaire
Time frame: After the 12 week intervention and captured in follow-up questionnaire for intervention arm participants
Satisfaction will be measured as participants' experience and perceptions of an internet intervention. Scale values: Not at all, slightly, somewhat, mostly \& very. Higher scores are associated with a greater level of satisfaction.
7 secondary outcomes
10 Repetition Maximum Test
Time frame: During the baseline assessment, week 12 assessment and week 24 follow up assessment
Godin Leisure Time Exercise Questionnaire
Time frame: During the baseline assessment, week 12 assessment and week 24 follow up assessment
Accelerometer (ActiGraph)
Time frame: Prior to intervention start and following the Week 12 and week 24 assessments
Senior Fitness Test
Time frame: During the baseline assessment, week 12 assessment and week 24 follow up assessment
Exercise Self-Efficacy Questionnaire
Time frame: During the baseline assessment, week 12 assessment and week 24 follow up assessment
Barrier Self-Efficacy Questionnaire
Time frame: During the baseline assessment, week 12 assessment and week 24 follow up assessment
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Time frame: Completed at baseline assessment, after completion of the intervention at week 12 and at the week 24 follow up
Results and safety
The study was stopped early (reason given: PI left). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Background: PubMed 21538678Ritterband 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.
- Background: PubMed 26264621Amireault 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.
- Background: PubMed 9060536Brady 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.
- Background: PubMed 10882320Resnick 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.
- Background: PubMed 8433355McAuley 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.
- 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.
- Derived from this study: PubMed 41990365Wakefield 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.
- Derived from this study: PubMed 39090218Fong AJ, Llanos AAM, Hudson SV, Schmitz K, Lu SE, Phillips SM, Manne SL. Online-delivered resistance exercise intervention among racially diverse breast cancer survivors: Feasibility, acceptability, and exploratory outcomes of B-REP. Support Care Cancer. 2024 Aug 1;32(8):565. doi: 10.1007/s00520-024-08769-9.
- Individual participant dataSharing planned: Yes. Individual data that underlie results will be shared after de-identification for analysis purposes. Data sources include: 1) clinical and physical assessment data collected at the CINJ, 2) patient-reported questionnaire data collected through REDCap in a personal device or study-specific iPad, 3) observational data collected from recording one-on-one exercise sessions, and 4) Interview audio from zoom and transcribed interviews The final dataset will not contain any information that could identify individuals. Data will be shared using secure, Rutgers email between the PI and Co-Is.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Fong, PhD principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online-delivered physical activity intervention. and Printed, individualized resistance-based physical activity program. in people with Breast Cancer and Resistance Training, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI left). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (participant retention) (time frame: 14 weeks including pre-intervention and post-intervention questionnaire completion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04562233, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.