Pilot SMART of a Remotely Delivered, Physical Activity Intervention for Breast Cancer Survivors
2026年8月27日 更新者：Courtney J. Stevens、Dartmouth-Hitchcock Medical Center
A Pilot Sequential, Multiple Assignment, Randomized Trial (SMART) of a Remotely Delivered, Physical Activity Intervention for Breast Cancer Survivors
The goal of this clinical trial is to evaluate the feasibility of randomizing participants to a "step-up" intervention pathway when they perform <150 minutes of MVPA at the 6-week data collection burst. Participants who performed <150 minutes of MVPA at the 6-week data collection burst will be randomized to either continue with the standard intervention or advance to the step-up intervention. The main questions it aims to answer are:
- What percentage of participants who are eligible for the intervention phase enroll in the intervention phase?
- Will participants assigned to the "step-up" intervention pathway demonstrate equal or greater rates of study retention and intervention engagement relative to those assigned to the standard intervention arm?
- What percentage of the sample is performing >150 minutes accelerometer measured MVPA/week at the intervention mid-point (week 6-data collection burst) and end-of-study (week 12-data collection burst)?
- Do at least 50% of participants assigned to the "step-up" intervention pathway achieve a clinically meaningful volume of weekly MVPA by 12-weeks follow-up?
All participants will:
- Be assigned to either the Affect-based exercise prescription or the Effort-based exercise prescription.
- Participate in three meetings with the interventionist (an exercise specialist) 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 consecutive days at 4 points in time: Baseline, 2weeks, 6weeks, and 12weeks.
Some participants (those performing <150 minutes of MVPA at the 6-week data collection burst) will be assigned to the step-up intervention pathway. Participants assigned to the step-up intervention pathway will complete 3 additional follow-up meetings with the interventionist. During these meetings, the interventionist will help participants identify opportunities to be more active, set goals, and problem solve barriers to action.
研究概览
地位
招聘中
条件
研究类型
介入性
注册 (估计的)
55
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Courtney J Stevens, PhD
- 电话号码：6036509643
- 邮箱：courtney.j.stevens@dartmouth.edu
研究联系人备份
- 姓名：Aislinn Mitcham, BA
- 电话号码：6036466545
- 邮箱：aislinn.e.mitcham@hitchcock.org
学习地点
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New Hampshire
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Lebanon、New Hampshire、美国、03756
- 招聘中
- Dartmouth-Hitchcock Clinic
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接触：
- Courtney J Stevens, PhD
- 电话号码：603-646-5451
- 邮箱：courtney.j.stevens@dartmouth.edu
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
-≥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
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Effort-based Exercise Prescription (RPE-Rx) Standard
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Core intervention content will be delivered during the Visit 1, 1-month, and 2-month-check-in meetings.
Definitions of exercise will be provided, participants will be asked to discuss their past experiences with exercise, guidelines for being safe during exercise will be reviewed, and strategies for overcoming potential barriers to exercise will be discussed.
All participants will be given an exercise plan organized according to the FIIT Principle (Frequency, Intensity, Time, and Type).
The intensity component of the exercise plan will differ by study arm, all other elements will be delivered the same for all participants.
All participants will be given the goal of increasing weekly time spent exercising to ≥150 minutes, consistent with recommended guidelines.
All participants will be given a smartwatch to support self-monitoring of exercise and activity levels throughout the 12-week study period.
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实验性的：Affect-based Exercise Prescription (Affect-Rx) Standard
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Core intervention content will be delivered during the Visit 1, 1-month, and 2-month-check-in meetings.
Definitions of exercise will be provided, participants will be asked to discuss their past experiences with exercise, guidelines for being safe during exercise will be reviewed, and strategies for overcoming potential barriers to exercise will be discussed.
All participants will be given an exercise plan organized according to the FIIT Principle (Frequency, Intensity, Time, and Type).
The intensity component of the exercise plan will differ by study arm, all other elements will be delivered the same for all participants.
All participants will be given the goal of increasing weekly time spent exercising to ≥150 minutes, consistent with recommended guidelines.
All participants will be given a smartwatch to support self-monitoring of exercise and activity levels throughout the 12-week study period.
Participants assigned to Affect-Rx will receive instructions to "select a pace of exercise that makes you feel as good as possible."
The exercise intensity prescription section of their exercise plan will include the Feeling Scale as an attachment and participants will be given the instruction to "stay in the green zone" on the Feeling Scale.
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有源比较器：Effort-based Exercise Prescription (RPE-Rx) Step-Up
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分配到 RPE-Rx 的参与者将收到指示，“选择一个节奏，让你很难进行简短的对话”。
他们的运动计划的运动强度处方部分将包括作为附件的感知劳累等级（RPE）量表，并且参与者将收到指示“保持在 RPE 量表上的绿色区域”。
Core intervention content will be delivered during the Visit 1, 1-month, and 2-month-check-in meetings.
Definitions of exercise will be provided, participants will be asked to discuss their past experiences with exercise, guidelines for being safe during exercise will be reviewed, and strategies for overcoming potential barriers to exercise will be discussed.
All participants will be given an exercise plan organized according to the FIIT Principle (Frequency, Intensity, Time, and Type).
The intensity component of the exercise plan will differ by study arm, all other elements will be delivered the same for all participants.
All participants will be given the goal of increasing weekly time spent exercising to ≥150 minutes, consistent with recommended guidelines.
All participants will be given a smartwatch to support self-monitoring of exercise and activity levels throughout the 12-week study period.
Core intervention content will be delivered during check-in meetings scheduled during study weeks 7, 8, 9, and 10.
During these visits, the interventionist will work with the participant to set weekly goals and problem-solving barriers to action.
All participants will continue to receive instructions to follow their assigned exercise prescription (Affect-based Exercise Prescription or Effort-based exercise prescription).
The step-up intervention calls are delivered the same regardless to which exercise prescription format the participant is assigned.
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实验性的：Affect-based Exercise Prescription (Affect-Rx) Step-Up
|
Core intervention content will be delivered during the Visit 1, 1-month, and 2-month-check-in meetings.
Definitions of exercise will be provided, participants will be asked to discuss their past experiences with exercise, guidelines for being safe during exercise will be reviewed, and strategies for overcoming potential barriers to exercise will be discussed.
All participants will be given an exercise plan organized according to the FIIT Principle (Frequency, Intensity, Time, and Type).
The intensity component of the exercise plan will differ by study arm, all other elements will be delivered the same for all participants.
All participants will be given the goal of increasing weekly time spent exercising to ≥150 minutes, consistent with recommended guidelines.
All participants will be given a smartwatch to support self-monitoring of exercise and activity levels throughout the 12-week study period.
Participants assigned to Affect-Rx will receive instructions to "select a pace of exercise that makes you feel as good as possible."
The exercise intensity prescription section of their exercise plan will include the Feeling Scale as an attachment and participants will be given the instruction to "stay in the green zone" on the Feeling Scale.
Core intervention content will be delivered during check-in meetings scheduled during study weeks 7, 8, 9, and 10.
During these visits, the interventionist will work with the participant to set weekly goals and problem-solving barriers to action.
All participants will continue to receive instructions to follow their assigned exercise prescription (Affect-based Exercise Prescription or Effort-based exercise prescription).
The step-up intervention calls are delivered the same regardless to which exercise prescription format the participant is assigned.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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6 周随访时的研究保留
大体时间：6周的跟踪评估。
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在参加研究的参与者人数中完成 6 周随访评估的参与者人数。
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6周的跟踪评估。
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12 周随访时的研究保留
大体时间：12周的随访评估。
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在参加研究的参与者人数中完成 12 周随访评估的参与者人数。
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12周的随访评估。
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Rate of Intervention Enrollment
大体时间：Baseline assessment.
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Number of participants who enroll in the intervention phase out of the number of participants who are eligible for the intervention phase
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Baseline assessment.
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Intervention Engagement
大体时间：12-weeks follow-up assessment.
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Number of intervention sessions completed out of the number of intervention sessions scheduled
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12-weeks follow-up assessment.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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通过参与者满意度调查问卷衡量的对研究参与的满意度
大体时间：12周的随访评估。
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一份包含 8 项的自我报告问卷，用于评估参与者对研究参与的满意度，使用李克特量表（1 至 4）。
将分数相加，然后平均；总分范围为 1-4。分数越高表示满意度越高。
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12周的随访评估。
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使用自愿运动问卷测量自愿运动行为的变化
大体时间：基线、6 周随访和 12 周随访。
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过去一个月和一周内进行的锻炼的 6 项自我报告测量。
两个项目的范围从 1（从不）到 7（经常），四个项目的范围从 0（每周 0 天）到 7（每周 7 天）。
总分范围为 2-21。
分数越高反映自愿锻炼行为水平越高。
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基线、6 周随访和 12 周随访。
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使用国际体力活动问卷 (IPAQ) 简表了解体力活动的变化
大体时间：基线、6 周随访和 12 周随访。
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一项包含 7 项的自我报告测量，计算成人参与者在一周内进行的与健康相关的剧烈和中等强度的体力活动以及静坐时间。
参与者每天报告的 3 类剧烈、中度和步行活动的分钟数乘以每个类别的平均代谢当量 (MET)（分别为 8.0 MET、4.9 MET 和 3.3 MET）。
将每个类别的分数相加，计算过去一周的身体活动分数，量化为总 MET 值。
较高的 METS 表明前一周完成的体力活动总量较高。
0-599 之间的 MET 值被视为“低活性”，600-1499 之间的 MET 值被视为“中度活性”，1500 或更高的 MET 值被视为“高活性”。
这项措施还评估了参与者过去一周的总坐时间。
报告的坐着时间的总分钟数不属于体力活动的一部分
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基线、6 周随访和 12 周随访。
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使用斯坦福休闲活动类别项目 (L-Cat) 测量的过去一个月完成的身体活动类别的变化
大体时间：基线、6 周随访和 12 周随访。
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一项单项自我报告测量，提供六种描述每月身体活动不同水平的陈述。
回答选项范围从 1（我没有进行太多体力活动）到 6（我几乎每天都进行剧烈活动）。
总分范围为 1-6。
分数越高反映出过去一个月完成的体力活动越剧烈、越频繁。
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基线、6 周随访和 12 周随访。
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Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 2 Weeks Follow-up
大体时间：Time Frame: 2-weeks follow-up assessment.
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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.
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Time Frame: 2-weeks follow-up assessment.
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Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 6 Weeks Follow-up.
大体时间：Time Frame: 6-weeks follow-up assessment
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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.
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Time Frame: 6-weeks follow-up assessment
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Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 12 Weeks Follow-up
大体时间：[Time Frame: 12-weeks follow-up assessment.
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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.
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[Time Frame: 12-weeks follow-up assessment.
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Intervention Acceptability Measured Using the Treatment Acceptability and Preferences (TAP) Measure
大体时间：12-weeks follow-up assessment.
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A 4-item self-report questionnaire used to measure intervention acceptability using a Likert scale ranging from 0 (not at all) to 4 (very much).
Total scores range from 0 - 16. Higher scores indicate greater acceptability.
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12-weeks follow-up assessment.
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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使用 PROMIS 疲劳简表 8a 测量的癌症相关疲劳加班变化
大体时间：基线和 12 周随访评估。
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过去 7 天的 8 项自我报告测量，响应选项范围从 1（完全不）到 5（非常），疲劳干扰范围从 1（从不）到 5（总是）。
总分范围为 8 - 40。
分数越高反映越疲劳。
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基线和 12 周随访评估。
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使用 PROMIS 全球健康量表测量的健康相关生活质量的变化
大体时间：基线和 12 周随访评估。
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10 项自我报告测量，第 1-9 项的回答选项范围为 1（差/从不/根本没有）到 5（极好/完全/总是）和 0（无疼痛）到 10（可想象的最严重疼痛）对于第 10 项。
总分范围为 9 - 45。分数越高代表健康相关的生活质量越好。
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基线和 12 周随访评估。
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使用 PROMIS 身体机能简表 8a 测量的身体机能随时间变化
大体时间：基线和 12 周随访评估。
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一项 8 项自我报告措施，回答选项范围从 1（无法做）到 5（没有任何困难），以及健康限制特定活动的程度，范围从 1（不能做）到 5（根本不做） ）。
总分范围为 8 - 40。
分数越高反映身体机能越好。
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基线和 12 周随访评估。
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使用 PROMIS 焦虑表测量焦虑随时间的变化
大体时间：基线和 12 周随访评估。
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一项包含 8 项的自我报告措施，回答选项范围为 1（从不）到 5（总是）。
总分范围为 8 - 40。
分数越高反映焦虑程度越高。
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基线和 12 周随访评估。
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使用 PROMIS 抑郁表改变抑郁症状的加班情况
大体时间：基线和 12 周随访评估。
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一项包含 8 项的自我报告措施，回答选项范围为 1（从不）到 5（总是）。
总分范围为 8 - 40。
分数越高反映抑郁症状水平越高。
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基线和 12 周随访评估。
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使用 PROMIS 睡眠障碍量表改变睡眠障碍的加班情况
大体时间：基线和 12 周随访评估。
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一项 8 项自我报告测量，其响应选项表明参与者可能经历的睡眠障碍程度。
第一个问题询问睡眠质量，范围从 1（非常好）到 5（非常差）。
问题2-8进一步询问睡眠体验的具体情况，范围从1（完全没有）到5（非常多）。
总分范围为 8 - 40。
分数越高反映睡眠障碍程度越高或睡眠质量越差。
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基线和 12 周随访评估。
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使用运动意图量表测量的运动意图加班变化
大体时间：基线、6 周随访和 12 周随访。
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衡量下周锻炼意愿的 5 项自我报告。
回答选项范围从 1（完全不可能）到 7（非常有可能）。
对响应进行求和，然后求平均值；总分范围为 1-7。
分数越高代表下周锻炼的意愿越强烈。
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基线、6 周随访和 12 周随访。
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使用身体活动享受量表-简式 (PACE-S) 改变身体活动享受的加班
大体时间：基线、6 周随访和 12 周随访。
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4 项自我报告措施，回答选项范围从 1（强烈不同意）到 5（强烈同意）。
总分范围为 4 - 20。
分数越高反映出进行身体活动时的愉悦程度越高。
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基线、6 周随访和 12 周随访。
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月30日
初级完成 (估计的)
2027年4月3日
研究完成 (估计的)
2027年6月3日
研究注册日期
首次提交
2026年7月10日
首先提交符合 QC 标准的
2026年7月10日
首次发布 (实际的)
2026年7月15日
研究记录更新
最后更新发布 (实际的)
2026年8月31日
上次提交的符合 QC 标准的更新
2026年8月27日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.