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Adaptive Mobile Interventions to Reduce Cancer Risk Behaviors

7. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

7

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Johannes Thrul, PhD
  • Telefonnummer: 443-318-6633
  • E-mail: jthrul@jhu.edu

Studiesteder

  • Forenede Stater
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21205
        • Johns Hopkins Bloomberg School of Public Health
        • Kontakt:
          • Johannes Thrul, PhD
          • Telefonnummer: 443-318-6633
          • E-mail: jthrul@jhu.edu

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: Smartphone-based intervention messages
Intervention messages will suggest strategies of coping with smoking urges in the moment.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in smoking urge as assessed by a single item
Tidsramme: 15 minutes after message delivery
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).
15 minutes after message delivery
Change in cigarettes smoked per day in past week as assessed by a single item
Tidsramme: Baseline, 45-day follow-up
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.
Baseline, 45-day follow-up
System Usability as assessed by the System Usability Scale (SUS)
Tidsramme: 45-day follow-up
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.
45-day follow-up

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Anden brug af tobaksvarer siden levering af interventionsbesked vurderet af en enkelt vare
Tidsramme: 15 minutter efter levering af besked
Anden brug af tobaksprodukter, herunder brug af e-cigaret, inden for 15 minutter efter levering af besked vil blive vurderet af et enkelt element på en binær svarskala (ja/nej).
15 minutter efter levering af besked
Aktivitetsgennemførelse vurderet af et enkelt element
Tidsramme: 15 minutter efter levering af besked
Selvrapporteret afslutning af anbefaling af interventionsbesked i EMA-postundersøgelser, anmodet 15 minutter efter levering af interventionsbesked, vil blive vurderet af et enkelt punkt på en binær svarskala (ja/nej).
15 minutter efter levering af besked
Selvrapporteret 7-dages punktprævalens abstinens vurderet ved et enkelt punkt
Tidsramme: 45 dages opfølgning
Selvrapporteret 7-dages punktprævalensabstinens (ingen rygning, ikke engang et sug) vil blive vurderet ved et enkelt punkt på en binær svarskala (ja/nej).
45 dages opfølgning
Smoking since intervention message delivery as assessed by a single item
Tidsramme: 15 minutes after message delivery
Smoking in the 15 minutes after message delivery will be assessed by a single item on a binary response scale (yes/no).
15 minutes after message delivery
Change in stress as assessed by a single item
Tidsramme: 15 minutes after message delivery
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).
15 minutes after message delivery
Change in negative affect as assessed by a single item
Tidsramme: 15 minutes after message delivery
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).
15 minutes after message delivery
Message helpfulness as assessed by a single item
Tidsramme: 15 minutes after message delivery
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).
15 minutes after message delivery
Change in cigarettes smoked as assessed by a single item
Tidsramme: Baseline, 45-day follow-up
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.
Baseline, 45-day follow-up
Tobacco quit attempt as a assessed by a single item
Tidsramme: 45-day follow-up
A tobacco quit attempt since the baseline assessment will be assessed by a single item on a binary response scale (yes/no).
45-day follow-up
Change in frequency and intensity of smoking urges as assessed by two items of the Mood and Physical Symptoms Scale (MPSS)
Tidsramme: Baseline, 45-day follow-up
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.
Baseline, 45-day follow-up
Change in psychological flexibility as assessed by the CompACT-15
Tidsramme: Baseline, 45-day follow-up
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.
Baseline, 45-day follow-up
Change in smoking-specific experiential avoidance as assessed by the Avoidance and Inflexibility Scale (AIS)
Tidsramme: Baseline, 45-day follow-up
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.
Baseline, 45-day follow-up
Tobacco product switching as assessed by 5 questions
Tidsramme: Baseline, 45-day follow-up
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.
Baseline, 45-day follow-up

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Samarbejdspartnere

Maryland Cigarette Restitution

Efterforskere

  • Ledende efterforsker: Johannes Thrul, PhD, Johns Hopkins Bloomberg School of Public Health

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

1. juli 2026

Studieafslutning (Anslået)

1. juli 2026

Datoer for studieregistrering

Først indsendt

7. maj 2026

Først indsendt, der opfyldte QC-kriterier

7. maj 2026

Først opslået (Faktiske)

13. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB00033759

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Johns Hopkins Bloomberg School of Public Health

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

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