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Adaptive Mobile Interventions to Reduce Cancer Risk Behaviors

10. september 2026 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

9

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Maryland
      • Baltimore, Maryland, Forente stater, 21205
        • Johns Hopkins Bloomberg School of Public Health

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske 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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: Smartphone-based intervention messages
Intervention messages will suggest strategies of coping with smoking urges in the moment.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
Tidsramme
Annen bruk av tobakksprodukter siden levering av intervensjonsmelding, vurdert av en enkelt vare
Tidsramme: 15 minutter etter levering av melding
Annen bruk av tobakksprodukter, inkludert bruk av e-sigarett, i løpet av 15 minutter etter meldingslevering vil bli vurdert av ett enkelt element på en binær svarskala (ja/nei).
15 minutter etter levering av melding
Aktivitetsgjennomføring vurdert av ett enkelt element
Tidsramme: 15 minutter etter levering av melding
Selvrapportert fullføring av anbefaling av intervensjonsmelding i EMA-post-undersøkelser, bedt om 15 minutter etter levering av intervensjonsmelding, vil bli vurdert av ett enkelt element på en binær svarskala (ja/nei).
15 minutter etter levering av melding
Selvrapportert 7-dagers punktprevalensavholdenhet vurdert ved ett enkelt element
Tidsramme: 45 dagers oppfølging
Selvrapportert 7-dagers poengprevalensavholdenhet (ingen røyking, ikke engang et drag) vil bli vurdert av et enkelt element på en binær svarskala (ja/nei).
45 dagers oppfølging
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Samarbeidspartnere

Maryland Cigarette Restitution

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

6. juli 2026

Primær fullføring (Faktiske)

9. september 2026

Studiet fullført (Faktiske)

9. september 2026

Datoer for studieregistrering

Først innsendt

7. mai 2026

Først innsendt som oppfylte QC-kriteriene

7. mai 2026

Først lagt ut (Faktiske)

13. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRB00033759

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Johns Hopkins Bloomberg School of Public Health

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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