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.
調査の概要
研究の種類
介入
入学 (実際)
9
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Maryland
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Baltimore、Maryland、アメリカ、21205
- Johns Hopkins Bloomberg School of Public Health
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in smoking urge as assessed by a single item
時間枠：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
時間枠：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)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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介入メッセージ配信以降の他のたばこ製品の使用は、単一項目で評価
時間枠：メッセージ配信後 15 分
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メッセージ配信後 15 分間の、電子タバコの使用を含むその他のタバコ製品の使用は、バイナリ応答スケール (はい/いいえ) で 1 つの項目によって評価されます。
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メッセージ配信後 15 分
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単一項目で評価されるアクティビティの完了
時間枠：メッセージ配信後 15 分
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介入メッセージ配信の 15 分後に促された EMA 投稿調査での介入メッセージ推奨の自己申告による完了は、バイナリ応答スケール (はい/いいえ) で単一の項目によって評価されます。
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メッセージ配信後 15 分
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単一の項目で評価された、自己申告の7日間のポイント有病率の禁酒
時間枠：45日間のフォローアップ
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自己申告による 7 日間のポイント有病率の禁酒 (禁煙、一服もしない) は、バイナリ応答スケール (はい/いいえ) で 1 つの項目によって評価されます。
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45日間のフォローアップ
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Smoking since intervention message delivery as assessed by a single item
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Johannes Thrul, PhD、Johns Hopkins Bloomberg School of Public Health
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年7月6日
一次修了 (実際)
2026年9月9日
研究の完了 (実際)
2026年9月9日
試験登録日
最初に提出
2026年5月7日
QC基準を満たした最初の提出物
2026年5月7日
最初の投稿 (実際)
2026年5月13日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月11日
QC基準を満たした最後の更新が送信されました
2026年9月10日
最終確認日
2026年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。