Breast Cancer and Resistance Exercise Program

Breast Cancer Clinical Trial

— B-REP  

Official title:

Breast Cancer and Resistance Exercise Program (B-REP): A Feasibility and Acceptability Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04562233
• Other study ID #: Pro2020002182
• Secondary ID: Pro2020002182132
• Status: Terminated
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: August 24, 2023

Study information

• Verified date: October 2023
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 56
• Est. completion date: August 24, 2023
• Est. primary completion date: August 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Resistance Training

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

References & Publications (7)

Amireault 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. Erratum In: BMC Med Res Methodol. 2016;16:30. — View Citation

Brady 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. — View Citation

Get 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.

McAuley 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. — View Citation

Resnick 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility (participant retention)	Participant retention at assessment timepoints (attendance and completing assessments)	14 weeks including pre-intervention and post-intervention questionnaire completion
Primary	Acceptability (program adherence)	Adherence to physical activity program/intervention (attendance and exercise logs)	12 weeks to complete the intervention
Primary	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.	After the 12 week intervention and captured in follow-up questionnaire for intervention arm participants
Secondary	10 Repetition Maximum Test	Changes in strength measured by 10RM assessment	During the baseline assessment, week 12 assessment and week 24 follow up assessment
Secondary	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.	During the baseline assessment, week 12 assessment and week 24 follow up assessment
Secondary	Accelerometer (ActiGraph)	Objective measure of total physical activity levels with intensity and duration (minutes). No scale.	Prior to intervention start and following the Week 12 and week 24 assessments
Secondary	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.	During the baseline assessment, week 12 assessment and week 24 follow up assessment
Secondary	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.	During the baseline assessment, week 12 assessment and week 24 follow up assessment
Secondary	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.	During the baseline assessment, week 12 assessment and week 24 follow up assessment
Secondary	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.	Completed at baseline assessment, after completion of the intervention at week 12 and at the week 24 follow up