Breast Cancer Clinical Trial

Breast Cancer and Resistance Exercise Program

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 OneDrive (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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

aged 18 years and older;
a confirmed diagnosed of breast cancer < 5 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
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.

Exclusion Criteria:

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);
did not have someone to supervise them while they exercised remotely.

Study is for people with:

Breast Cancer

Estimated Enrollment:

50

Study ID:

NCT04562233

Recruitment Status:

Recruiting

Sponsor:

Rutgers, The State University of New Jersey

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There is 1 Location for this study

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Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08903, United States More Info
Bianca Anuforo, MPH
Contact
Angela Fong, PhD
Contact

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

50

Study ID:

NCT04562233

Recruitment Status:

Recruiting

Sponsor:


Rutgers, The State University of New Jersey

How clear is this clinincal trial information?

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