Clinical trial NCT04562233: Breast Cancer and Resistance Exercise Program
Official title: Breast Cancer and Resistance Exercise Program (B-REP): A Feasibility and Acceptability Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Resistance Training
Keywords: online
breast cancer
physical activity
breast neoplasm
resistance exercise
survivor
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility (participant retention)
timeFrame: 14 weeks including pre-intervention and post-intervention questionnaire completion
measure: Acceptability (program adherence)
timeFrame: 12 weeks to complete the intervention
measure: Internet Evaluation and Utility Questionnaire
timeFrame: After the 12 week intervention and captured in follow-up questionnaire for intervention arm participants
Secondary outcomes:
measure: 10 Repetition Maximum Test
timeFrame: During the baseline assessment, week 12 assessment and week 24 follow up assessment
measure: Godin Leisure Time Exercise Questionnaire
timeFrame: During the baseline assessment, week 12 assessment and week 24 follow up assessment
measure: Accelerometer (ActiGraph)
timeFrame: Prior to intervention start and following the Week 12 and week 24 assessments
measure: Senior Fitness Test
timeFrame: During the baseline assessment, week 12 assessment and week 24 follow up assessment
measure: Exercise Self-Efficacy Questionnaire
timeFrame: During the baseline assessment, week 12 assessment and week 24 follow up assessment
measure: Barrier Self-Efficacy Questionnaire
timeFrame: During the baseline assessment, week 12 assessment and week 24 follow up assessment
measure: Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
timeFrame: Completed at baseline assessment, after completion of the intervention at week 12 and at the week 24 follow up
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Angela Fong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Get Active Questionnaire. Ottawa, Canada: Canadian Society of Exercise Physiology, 2016.
citation: 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.