Adaptive Mobile Interventions to Reduce Cancer Risk Behaviors
2026年9月10日 更新者：Johns Hopkins Bloomberg School of Public Health
Tobacco use remains the leading cause of preventable death, causing over 400,000 annual deaths in the United States alone. Smartphone-based interventions, particularly those leveraging real-time adaptive messaging, represent a promising yet underutilized approach to delivering personalized tobacco and cannabis treatment. The investigator's ongoing NCI funded micro-randomized trial (MRT; R01 CA246590) has shown initial feasibility in reducing smoking urges through situationally tailored cognitive-behavioral therapy (CBT) and mindfulness-based acceptance and commitment-based therapy (ACT) messages triggered by real-time contextual data (e.g., geolocation, momentary stress). To advance from a static MRT framework to a dynamic, data-driven just-in-time adaptive intervention (JITAI), this project aims to develop, test, and refine a reinforcement learning (RL) algorithm that can continuously adapt to user needs in real-time, enhancing treatment outcomes for various tobacco and cannabis products.
To ensure optimal usability and engagement, the investigators will conduct user-centered testing with the developed RL-based intervention delivery in one cohort (N=7) over 45 days. This will include usability assessment via the System Usability Scale, analysis of app interaction metrics, and semi-structured interviews to gather feedback for refining message content, timing, and design.
研究概览
研究类型
介入性
注册 (实际的)
9
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。
学习地点
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Maryland
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Baltimore、Maryland、美国、21205
- Johns Hopkins Bloomberg School of Public Health
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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
接受健康志愿者
是的
描述
Inclusion Criteria:
- live in the U.S.;
- are between 18 and 40 years of age;
- own a smartphone with iOS and Android operating system and GPS capabilities;
- are carrying smartphone every day;
- are willing to participate in the study for 44 days and give the research team access to the phone GPS data;
- have smoked ≥100 cigarettes in the participant's life and currently smoke at least 3 cigarettes per day on 5 or more days of the week;
- are planning to quit smoking within the next 30 days.
Exclusion Criteria:
- None
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：治疗
- 分配：不适用
- 介入模型：单组作业
- 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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实验性的：RL-informed intervention
Participants complete a 14-day Ecological Momentary Assessment (EMA) training phase using a smartphone app (MetricWire), during which the participant responds to up to 3 randomly prompted and cigarette-triggered EMA surveys per day while the app passively collects GPS data.
These data are used to identify high-risk locations and time periods and to inform a previously trained reinforcement learning (RL) algorithm.
During the subsequent 30-day intervention phase, the RL algorithm delivers personalized intervention messages (cognitive-behavioral therapy [CBT], acceptance and commitment therapy [ACT], or attention control) triggered by geofence entry at high-risk locations.
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Intervention messages will suggest strategies of coping with smoking urges in the moment.
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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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Change in smoking urge as assessed by a single item
大体时间：15 minutes after message delivery
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The primary outcome will be change in participants' rating of smoking urge in EMA-post surveys, prompted 15 minutes after intervention message delivery, and controlling for the ratings in EMA-pre surveys.
Urge will be assessed by a single item on a 5-point scale, ranging from 1-5; (1-very low, to 5-very high).
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15 minutes after message delivery
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Change in cigarettes smoked per day in past week as assessed by a single item
大体时间：Baseline, 45-day follow-up
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The primary outcome will be change in self-reported number of cigarettes smoked per day in the past week from baseline to 45-day follow-up.
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Baseline, 45-day follow-up
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System Usability as assessed by the System Usability Scale (SUS)
大体时间：45-day follow-up
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The primary outcome will be assessment of the intervention app usability assessed by a slightly modified version of the 10-item System Usability Scale ("system" wording changed to "app").
Each item is assessed on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree).
The SUS total score ranges from 0-100, with higher scores indicating greater usability.
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45-day follow-up
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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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自干预信息传递以来的其他烟草产品使用情况，由单个项目评估
大体时间：消息传递后 15 分钟
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信息传递后 15 分钟内的其他烟草产品使用情况，包括电子烟的使用情况，将通过二元反应量表（是/否）上的单个项目进行评估。
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消息传递后 15 分钟
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以单个项目评估的活动完成情况
大体时间：消息传递后 15 分钟
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在 EMA 后调查中自我报告完成干预消息推荐，在干预消息传递后 15 分钟提示将通过二进制响应量表（是/否）上的单个项目进行评估。
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消息传递后 15 分钟
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通过单个项目评估的自我报告的 7 天点普遍戒断
大体时间：45 天随访
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自我报告的 7 天点流行戒烟（不吸烟，甚至不吸一口烟）将通过二元反应量表（是/否）上的单个项目进行评估。
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45 天随访
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Smoking since intervention message delivery as assessed by a single item
大体时间：15 minutes after message delivery
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Smoking in the 15 minutes after message delivery will be assessed by a single item on a binary response scale (yes/no).
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15 minutes after message delivery
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Change in stress as assessed by a single item
大体时间：15 minutes after message delivery
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Change in rating of stress in EMA-post surveys, prompted 15 minutes after intervention message delivery, and controlling for the ratings in EMA-pre surveys.
Stress will be assessed by a single item on a 5-point scale ranging from 1-5 (1-very low, to 5-very high).
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15 minutes after message delivery
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Change in negative affect as assessed by a single item
大体时间：15 minutes after message delivery
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Change in rating of negative affect in EMA-post surveys, prompted 15 minutes after intervention message delivery, and controlling for the ratings in EMA-pre surveys.
Negative affect will be assessed by a single item on a 5-point scale ranging from 1-5 (1-very low, to 5-very high).
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15 minutes after message delivery
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Message helpfulness as assessed by a single item
大体时间：15 minutes after message delivery
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Rating of message helpfulness in EMA-post surveys, prompted 15 minutes after intervention message delivery.
This will be assessed by a single item on a 5-point scale ranging from 1-5 (1-not at all helpful, to 5-extremely helpful).
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15 minutes after message delivery
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Change in cigarettes smoked as assessed by a single item
大体时间：Baseline, 45-day follow-up
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Change (reduction) in cigarettes smoked by at least 50% between baseline and 45-day follow-up.
Reduction will be calculated based on self-reported number of cigarettes/day in the past week.
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Baseline, 45-day follow-up
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Tobacco quit attempt as a assessed by a single item
大体时间：45-day follow-up
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A tobacco quit attempt since the baseline assessment will be assessed by a single item on a binary response scale (yes/no).
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45-day follow-up
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Change in frequency and intensity of smoking urges as assessed by two items of the Mood and Physical Symptoms Scale (MPSS)
大体时间：Baseline, 45-day follow-up
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Change in frequency and intensity of smoking urges will be assessed by two craving items from the Assessed with the Mood and Physical Symptoms Scale (MPSS) - subscale MPSS(C).
Both items will be assessed on a 6-point scale from 0 (not at all / no urges) to 5 (all the time / extremely strong).
Score range 0-10.
Lower score better.
Both items will be combined into the MPSS(C) subscale for analysis.
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Baseline, 45-day follow-up
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Change in psychological flexibility as assessed by the CompACT-15
大体时间：Baseline, 45-day follow-up
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Change in psychological flexibility from baseline to 45-day follow-up will be assessed by the CompACT-15.
The CompACT-15 total score ranges from 0-90, with higher scores indicating better psychological flexibility.
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Baseline, 45-day follow-up
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Change in smoking-specific experiential avoidance as assessed by the Avoidance and Inflexibility Scale (AIS)
大体时间：Baseline, 45-day follow-up
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Change in smoking-specific experiential avoidance from baseline to 45-day follow-up will be assessed by the Avoidance and Inflexibility Scale (AIS).
Items are scored on a scale of 1-5 and combined into a total score.
Score range 13-65, higher total score indicates a more avoidant and inflexible response to internal states associated with smoking.
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Baseline, 45-day follow-up
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Tobacco product switching as assessed by 5 questions
大体时间：Baseline, 45-day follow-up
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Switching to other tobacco products including e-cigarettes from baseline to 45-day follow-up will be assessed using questions about past 7-day use of cigarettes, e-cigarettes, cigars / cigarillos / little cigars, smokeless tobacco, and hookah / waterpipe.
Participants will be coded as having switched if the participant does not report cigarette smoking, but use of another tobacco product at a follow-up assessment.
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Baseline, 45-day follow-up
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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。
调查人员
- 首席研究员：Johannes Thrul, PhD、Johns Hopkins Bloomberg School of Public Health
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7月6日
初级完成 (实际的)
2026年9月9日
研究完成 (实际的)
2026年9月9日
研究注册日期
首次提交
2026年5月7日
首先提交符合 QC 标准的
2026年5月7日
首次发布 (实际的)
2026年5月13日
研究记录更新
最后更新发布 (实际的)
2026年9月11日
上次提交的符合 QC 标准的更新
2026年9月10日
最后验证
2026年9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.