Adaptive Mobile Interventions to Reduce Cancer Risk Behaviors
10 de septiembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
9
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Maryland
-
Baltimore, Maryland, Estados Unidos, 21205
- Johns Hopkins Bloomberg School of Public Health
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
Intervention messages will suggest strategies of coping with smoking urges in the moment.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in smoking urge as assessed by a single item
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Uso de otros productos de tabaco desde la entrega del mensaje de intervención evaluado por un solo ítem
Periodo de tiempo: 15 minutos después de la entrega del mensaje
|
El uso de otros productos de tabaco, incluido el uso de cigarrillos electrónicos, en los 15 minutos posteriores a la entrega del mensaje se evaluará mediante un solo ítem en una escala de respuesta binaria (sí/no).
|
15 minutos después de la entrega del mensaje
|
|
Finalización de la actividad evaluada por un solo ítem
Periodo de tiempo: 15 minutos después de la entrega del mensaje
|
La finalización autoinformada de la recomendación del mensaje de intervención en las encuestas posteriores a la EMA, solicitada 15 minutos después de la entrega del mensaje de intervención, se evaluará mediante un solo ítem en una escala de respuesta binaria (sí/no).
|
15 minutos después de la entrega del mensaje
|
|
Abstinencia de prevalencia puntual de 7 días autoinformada evaluada por un solo ítem
Periodo de tiempo: Seguimiento de 45 días
|
La abstinencia de prevalencia puntual de 7 días autoinformada (no fumar, ni siquiera una bocanada) se evaluará mediante un solo ítem en una escala de respuesta binaria (sí/no).
|
Seguimiento de 45 días
|
|
Smoking since intervention message delivery as assessed by a single item
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Johannes Thrul, PhD, Johns Hopkins Bloomberg School of Public Health
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
6 de julio de 2026
Finalización primaria (Actual)
9 de septiembre de 2026
Finalización del estudio (Actual)
9 de septiembre de 2026
Fechas de registro del estudio
Enviado por primera vez
7 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
7 de mayo de 2026
Publicado por primera vez (Actual)
13 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB00033759
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Johns Hopkins Bloomberg School of Public Health
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .