Clinical trial · Interventional
Multi-Theory Model-Based AI Agent Intervention for Smoking Cessation in Early-Stage Cancer Patients
Construction and Effectiveness of a Multi-Theory Model-Based AI Agent Intervention for Smoking Cessation Among Early-Stage Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to evaluate the effectiveness of a Multi-Theory Model (MTM)-based AI agent intervention for smoking cessation in early-stage cancer patients (clinical stage cTNM 0\~II) who currently smoke. The main questions it aims to answer are: Does the AI agent intervention improve the biochemically verified 7-day point prevalence abstinence rate at the 6-month follow-up compared to control groups? Is the AI agent intervention feasible and acceptable for early-stage cancer patients? Researchers will compare the AI agent intervention group to an professional counseling group and a routine health education groupto see if the AI agent yields higher smoking cessation rates and better maintenance of abstinence. Participants will: Be randomly assigned to one of three groups to receive either AI agent support via WeChat, professional counseling via Phone, or routine health education. Interact with the AI agent (if in the intervention group) which provides personalized guidance, emotional support, and resource matching based on the Multi-Theory Model constructs (e.g., participatory dialogue, emotional transformation). Complete questionnaires regarding smoking behavior, nicotine dependence, self-efficacy, and quality of life at baseline and follow-ups (1 week, 1 month, 3 months, and 6 months). Provide exhaled carbon monoxide (CO) and saliva cotinine samples for biochemical verification if they report successful smoking cessation.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AI Agent | — | UNRESOLVED | — |
| Early-Stage Cancer | — | UNRESOLVED | — |
| Smoking Cessation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Counseling | Behavioral | — | UNRESOLVED |
| MTM-Based AI Agent for smoking cessation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- AI Agent Intervention Group
- description
- Participants in this group will access a customized "Smoking Cessation AI Agent" via the WeChat platform. The agent utilizes a Large Language Model with Retrieval-Augmented Generation (RAG) to provide professional, evidence-based support grounded in the Multi-Theory Model (MTM). Key features include: 24/7 Personalized Interaction: Offers open-ended dialogue, personalized advice, and proactive pushes (e.g., health education cards, check-in incentives). Stage-Matched Guidance: Initiation Phase: Focuses on participatory dialogue to weigh pros/cons and behavioral confidence building through goal setting. Maintenance Phase: Focuses on emotional transformation (managing withdrawal/emotions), practice for change, and modifying the social/physical environment (e.g., matching cessation resources, peer support). Dynamic Adaptation: The agent dynamically adjusts its strategies based on the user's interaction frequency and quitting progress.
- interventionNames
- Behavioral: MTM-Based AI Agent for smoking cessation
- type
- ACTIVE_COMPARATOR
- label
- Counseling Group
- description
- Participants in this group receive smoking cessation counseling by WeChat from specialists. Proactive Intervention: Specialists contact participants twice a month. Content: Brief counseling (approx. 30 seconds to 5 minutes) based on WHO guidelines, including assessing smoking status, difficulties, and progress, and providing customized advice (e.g., motivation boosting, coping strategies for withdrawal). Reactive Support: Participants can proactively contact the specialists during working hours (Mon-Fri, 8:00-17:00) for inquiries.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥18 years, diagnosed with early-stage cancer (AJCC 8th edition clinical stage cTNM 0-II); 2. Smoked in the past 30 days, with an average daily consumption of \> 1 cigarette, and an exhaled Carbon Monoxide (CO) level ≥ 4 ppm; 3. Able to communicate using WeChat; 4. Able to understand and read Chinese, and possess conversational Mandarin skills; 5. Willing to participate in this study and sign the informed consent form. Exclusion Criteria: 1. Individuals who are unable to communicate due to severe mental or physical illness; 2. Individuals currently participating in other tobacco control research projects; 3. Individuals whose cancer has metastasized.
References
Publications (0)
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