Adaptive Mobile Interventions to Reduce Cancer Risk Behaviors

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorJohns Hopkins Bloomberg School of Public Health

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Smartphone-based intervention messages

    Behavioral

    Intervention messages will suggest strategies of coping with smoking urges in the moment.

Treatment groups

7 Participants
are divided into 1 treatment group
Group A: RL-informed interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in smoking urge as assessed by a single item

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).

Time frame
15 minutes after message delivery
2

Change in cigarettes smoked per day in past week as assessed by a single item

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.

Time frame
Baseline, 45-day follow-up
3

System Usability as assessed by the System Usability Scale (SUS)

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.

Time frame
45-day follow-up

Secondary outcomes

1

Smoking since intervention message delivery as assessed by a single item

Smoking in the 15 minutes after message delivery will be assessed by a single item on a binary response scale (yes/no).

Time frame
15 minutes after message delivery
2

Other tobacco product use since intervention message delivery as assessed by a single item

Other tobacco product use, including e-cigarette use, in the 15 minutes after message delivery will be assessed by a single item on a binary response scale (yes/no).

Time frame
15 minutes after message delivery
3

Change in stress as assessed by a single item

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).

Time frame
15 minutes after message delivery
4

Change in negative affect as assessed by a single item

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).

Time frame
15 minutes after message delivery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins Bloomberg School of Public Health

Lead sponsor

Maryland Cigarette Restitution

Collaborator

This trial is not recruiting at the moment. You can still explore other options: