Adaptive Mobile Interventions to Reduce Cancer Risk Behaviors
10 september 2026 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
9
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Maryland
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Baltimore, Maryland, Förenta staterna, 21205
- Johns Hopkins Bloomberg School of Public Health
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Ja
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in smoking urge as assessed by a single item
Tidsram: 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
Tidsram: 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)
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Annan tobaksvaruanvändning sedan interventionsmeddelande leverans bedömd av en enskild artikel
Tidsram: 15 minuter efter meddelandeleverans
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Annan användning av tobaksprodukter, inklusive användning av e-cigaretter, inom 15 minuter efter meddelandeleverans kommer att bedömas av ett enda objekt på en binär svarsskala (ja/nej).
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15 minuter efter meddelandeleverans
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Aktivitetens slutförande bedöms av ett enda objekt
Tidsram: 15 minuter efter meddelandeleverans
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Självrapporterat slutförande av rekommendation för interventionsmeddelande i EMA-postenkäter, efterfrågat 15 minuter efter leverans av interventionsmeddelande kommer att bedömas av ett enda objekt på en binär svarsskala (ja/nej).
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15 minuter efter meddelandeleverans
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Självrapporterad 7-dagars-punktsprevalensabstinens bedömd av ett enda objekt
Tidsram: 45 dagars uppföljning
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Självrapporterad 7-dagars prevalensavhållsamhet (ingen rökning, inte ens ett bloss) kommer att bedömas av ett enda objekt på en binär svarsskala (ja/nej).
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45 dagars uppföljning
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Smoking since intervention message delivery as assessed by a single item
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Johannes Thrul, PhD, Johns Hopkins Bloomberg School of Public Health
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
6 juli 2026
Primärt slutförande (Faktisk)
9 september 2026
Avslutad studie (Faktisk)
9 september 2026
Studieregistreringsdatum
Först inskickad
7 maj 2026
Först inskickad som uppfyllde QC-kriterierna
7 maj 2026
Första postat (Faktisk)
13 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB00033759
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
Johns Hopkins Bloomberg School of Public Health
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- ANALYTIC_CODE
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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