Increasing Physical Activity Among Breast Cancer Survivors: Use of the ORBIT Model to Refine and Test a Novel Approach to Exercise Promotion Based on Affect-regulation (Study 2)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 6 Weeks Follow-up
研究概览
简要总结
The goal of this clinical trial is to test the effect of an affect-based exercise prescription on moderate-vigorous physical activity participation among survivors of breast cancer who completed primary treatment within the last 5 years. The main questions it aims to answer are:
- Do at least 50% of participants assigned to the affect-based exercise prescription engage in ≥90 minutes of moderate-vigorous physical activity by the end of 12-weeks follow-up?
- What level of satisfaction do breast cancer survivors who receive the affect-based exercise prescription report relative to breast cancer survivors who receive an effort-based exercise prescription.
- What proportion of participants assigned to the affect-based exercise prescription stay enrolled in the study relative to the number of participants who stay enrolled in the effort-based exercise prescription.
All participants will:
- Be assigned to either the Affect-based exercise prescription or the Effort-based exercise prescription.
- Participate in two meetings with a member of the study team meant to help them get started increasing weekly exercise. These meetings are the same for all participants.
- Be asked to wear an activity monitor and respond to brief surveys for 10 straight days at 4 points in time: Baseline, 2weeks, 6weeks, and 12weeks.
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
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old
- •Within 5 years of completing primary cancer treatment (surgery, chemotherapy, and radiation) for Stage 0-III breast cancer
- •<60 mins/week moderate-vigorous physical activity (MVPA) with no major changes for the past 6- months
- •Own an Android or iPhone smartphone (or tablet) and willing to use it to complete app-based surveys during assessment periods
- •Willing to wear the ActiGraph monitor during assessment periods
- •Access to internet to complete REDCap survey assessments
排除标准
- •Non-English speaking/not able to read English
- •Evidence of major contraindications for exercise (informed by the 2020 Physical Activity Readiness-Questionnaire (PAR-Q)+)
- •Currently pregnant
- •History of severe mental illness or currently taking mood stabilizing medications (antipsychotics, anticonvulsants, or lithium)
- •Evidence of moderate-severe depressive symptoms (indicated by a score≥ 10 on the Patient Health Questionnaire-8)
- •Evidence of moderate-severe cognitive impairment (indicated by a score < 3 on a 6-item cognitive screener)
- •Evidence of clinically significant substance use as indicated by a score of ≥ 2 on the CAGE- AID screener.
研究组 & 干预措施
Effort-based Exercise Prescription (RPE-Rx)
干预措施: Effort-based exercise prescription (Behavioral)
Affect-based Exercise Prescription (Affect-Rx)
干预措施: Core Exercise Promotion Program (Behavioral)
Affect-based Exercise Prescription (Affect-Rx)
干预措施: Affect-based exercise prescription (Behavioral)
Effort-based Exercise Prescription (RPE-Rx)
干预措施: Core Exercise Promotion Program (Behavioral)
结局指标
主要结局
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 6 Weeks Follow-up
时间窗: 6-weeks follow-up assessment.
The research grade ActiGraph wGT3X-BT model is a valid measure of physical activity intensity and duration among multiple populations, including breast cancer survivors. Minutes of moderate-vigorous physical activity will be collected from the ActiGraph wGT3X-BT every day for 10-days. Average minutes of moderate-vigorous physical activity completed per day of valid wear time will be calculated.
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 2 Weeks Follow-up
时间窗: 2-weeks follow-up assessment.
The research grade ActiGraph wGT3X-BT model is a valid measure of physical activity intensity and duration among multiple populations, including breast cancer survivors. Minutes of moderate-vigorous physical activity will be collected from the ActiGraph wGT3X-BT every day for 10-days. Average minutes of moderate-vigorous physical activity completed per day of valid wear time will be calculated.
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 12 Weeks Follow-up
时间窗: 12-weeks follow-up assessment.
The research grade ActiGraph wGT3X-BT model is a valid measure of physical activity intensity and duration among multiple populations, including breast cancer survivors. Minutes of moderate-vigorous physical activity will be collected from the ActiGraph wGT3X-BT every day for 10-days. Average minutes of moderate-vigorous physical activity completed per day of valid wear time will be calculated.
次要结局
- Satisfaction With Study Participation as Measured by the Participant Satisfaction Questionnaire(12-weeks follow-up assessment.)
- Study Retention at 2-weeks Follow-up(2-weeks follow-up assessment.)
- Study Retention at 6-weeks Follow-up(6-weeks follow-up assessment.)
- Study Retention at 12-weeks Follow-up(12-weeks follow-up assessment.)
- Acceptability of the Affect-regulated Exercise Prescription Measured Using the Treatment Acceptability and Preferences (TAP) Measure(12-weeks follow-up assessment.)
- Change in Voluntary Exercise Behavior Measured Using The Voluntary Exercise Questionnaire(Baseline, 6-weeks follow-up, and 12-weeks follow-up.)
- Change in Physical Activity Category Completed in the Past Month Measured Using the Stanford Leisure-Time Activity Categorical Item (L-Cat)(Baseline, 6-weeks follow-up, and 12-weeks follow-up.)
- Change in Physical Activity using The International Physical Activity Questionnaire (IPAQ)-Short Form(Baseline, 6-weeks follow-up, and 12-weeks follow-up.)
研究者
Courtney J. Stevens
Assistant Professor of Psychiatry
Dartmouth-Hitchcock Medical Center