Breast Cancer and Resistance Exercise Program (B-REP): A Feasibility and Acceptability Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Feasibility (participant retention)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
- •are able to exercise safely as per physical activity safety screening questionnaire, Get Active Questionnaire
- •read and understand English
- •h) have regular access to an internet-connected device with a video camera.
排除标准
- •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.
结局指标
主要结局
Feasibility (participant retention)
时间窗: 14 weeks including pre-intervention and post-intervention questionnaire completion
Participant retention at assessment timepoints (attendance and completing assessments)
Acceptability (program adherence)
时间窗: 12 weeks to complete the intervention
Adherence to physical activity program/intervention (attendance and exercise logs)
Internet Evaluation and Utility Questionnaire
时间窗: 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.
次要结局
- Accelerometer (ActiGraph)(Prior to intervention start and following the Week 12 and week 24 assessments)
- Senior Fitness Test(During the baseline assessment, week 12 assessment and week 24 follow up assessment)
- 10 Repetition Maximum Test(During the baseline assessment, week 12 assessment and week 24 follow up assessment)
- Godin Leisure Time Exercise Questionnaire(During the baseline assessment, week 12 assessment and week 24 follow up assessment)
- Exercise Self-Efficacy Questionnaire(During the baseline assessment, week 12 assessment and week 24 follow up assessment)
- Barrier Self-Efficacy Questionnaire(During the baseline assessment, week 12 assessment and week 24 follow up assessment)
- Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)(Completed at baseline assessment, after completion of the intervention at week 12 and at the week 24 follow up)
研究者
CINJRegulatory
Administrative
Rutgers, The State University of New Jersey