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Recruiting NCT07585357

Adaptive Mobile Interventions to Reduce Cancer Risk Behaviors

No phase Interventional Smoking Cessation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Smartphone-based intervention messages.
Who it may be relevant to
Registry conditions: Smoking Cessation. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Behavioral Smartphone-based intervention messages
    Intervention messages will suggest strategies of coping with smoking urges in the moment.

Primary outcome measures

  • Change in smoking urge as assessed by a single item [Time frame: 15 minutes after message delivery]
  • Change in cigarettes smoked per day in past week as assessed by a single item [Time frame: Baseline, 45-day follow-up]
  • System Usability as assessed by the System Usability Scale (SUS) [Time frame: 45-day follow-up]
Secondary outcome measures (12)
  • Smoking since intervention message delivery as assessed by a single item [Time frame: 15 minutes after message delivery]
  • Other tobacco product use since intervention message delivery as assessed by a single item [Time frame: 15 minutes after message delivery]
  • Change in stress as assessed by a single item [Time frame: 15 minutes after message delivery]
  • Change in negative affect as assessed by a single item [Time frame: 15 minutes after message delivery]
  • Message helpfulness as assessed by a single item [Time frame: 15 minutes after message delivery]
  • Activity completion as assessed by a single item [Time frame: 15 minutes after message delivery]
  • Self-reported 7-day point prevalence abstinence as assessed by a single item [Time frame: 45-day follow-up]
  • Change in cigarettes smoked as assessed by a single item [Time frame: Baseline, 45-day follow-up]
  • Tobacco quit attempt as a assessed by a single item [Time frame: 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) [Time frame: Baseline, 45-day follow-up]
  • Change in psychological flexibility as assessed by the CompACT-15 [Time frame: Baseline, 45-day follow-up]
  • Change in smoking-specific experiential avoidance as assessed by the Avoidance and Inflexibility Scale (AIS) [Time frame: Baseline, 45-day follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Johns Hopkins Bloomberg School of Public Health — Baltimore

Identifiers

NCT: NCT07585357 · IRB00033759

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗