Adaptive Mobile Interventions to Reduce Cancer Risk Behaviors
2026년 5월 7일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (추정된)
7
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Johannes Thrul, PhD
- 전화번호: 443-318-6633
- 이메일: jthrul@jhu.edu
연구 장소
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Maryland
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Baltimore, Maryland, 미국, 21205
- Johns Hopkins Bloomberg School of Public Health
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연락하다:
- Johannes Thrul, PhD
- 전화번호: 443-318-6633
- 이메일: jthrul@jhu.edu
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
예
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in smoking urge as assessed by a single item
기간: 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
기간: 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)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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단일 항목으로 평가된 개입 메시지 전달 이후 기타 담배 제품 사용
기간: 메시지 전달 후 15분
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메시지 전달 후 15분 이내에 전자 담배 사용을 포함한 기타 담배 제품 사용은 이항 응답 척도(예/아니오)의 단일 항목으로 평가됩니다.
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메시지 전달 후 15분
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단일 항목으로 평가되는 활동 완료
기간: 메시지 전달 후 15분
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EMA 사후 설문조사에서 개입 메시지 권장 사항의 자체 보고 완료, 개입 메시지 전달 후 15분이 지나면 이진 응답 척도(예/아니오)의 단일 항목으로 평가됩니다.
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메시지 전달 후 15분
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단일 항목으로 평가한 자가 보고된 7일 포인트 유병률 금욕
기간: 45일 추적
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자가 보고된 7일 포인트 유병률 금욕(금연, 심지어 퍼프도 안됨)은 이항 응답 척도(예/아니오)에서 단일 항목으로 평가됩니다.
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45일 추적
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Smoking since intervention message delivery as assessed by a single item
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Johannes Thrul, PhD, Johns Hopkins Bloomberg School of Public Health
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 5월 1일
기본 완료 (추정된)
2026년 7월 1일
연구 완료 (추정된)
2026년 7월 1일
연구 등록 날짜
최초 제출
2026년 5월 7일
QC 기준을 충족하는 최초 제출
2026년 5월 7일
처음 게시됨 (실제)
2026년 5월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 7일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .