An interventional study of MTM-Based AI Agent for smoking cessation and Counseling in Smoking Cessation, Early-Stage Cancer and AI Agent, sponsored by Sun Yat-sen University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment
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.
1,581 studies on the registry are indexed under Smoking Cessation; 198 are open to participants now.
This study's planned enrollment of 156 is close to the median of 164 across 1,423 interventional studies indexed under Smoking Cessation.
Browse Smoking Cessation studies →Sun Yat-sen University is the lead sponsor of 1,690 studies on the registry; 619 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: MTM-Based AI Agent for smoking cessation
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.
Behavioral: Counseling
Participants receive standard care only, which consists of routine brief smoking cessation advice from physicians during their regular hospital visits. This group does not receive any additional active intervention, education, or follow-up counseling from the research team, except for data collection at scheduled follow-up points (baseline, 1 week, 1 month, 3 months, and 6 months).
An AI agent powered by a Large Language Model with Retrieval-Augmented Generation (RAG). It provides 24/7 personalized smoking cessation support based on the Multi-Theory Model (MTM). Key Functions: Initiation Phase: Participatory dialogue to weigh pros/cons and goal setting to build behavioral confidence. Maintenance Phase: Emotional transformation support, habit tracking (practice for change), and social/physical environment resource matching (e.g., peer support). Dynamic Adaptation: Adjusts content and push frequency based on user interaction and quitting stage.
WeChat-based counseling provided by smoking cessation specialists twice a month, following WHO guidelines.
Biochemically validated 7-Day Point Prevalence Abstinence Rate
Participants are considered abstinent if they self-report having smoked 0 cigarettes (not even a puff) in the past 7 days, confirmed by a biochemical validation of exhaled Carbon Monoxide (CO) concentration \< 4 ppm and saliva cotinine concentration \< 115 ng/ml
Time frame: 6 month follow-up after randomization
Self-Reported 7-Day Point Prevalence Abstinence Rate
The proportion of participants who self-report having smoked no cigarettes in the past 7 days, without biochemical verification at interim time points.
Time frame: 1 week, 1 month, 3 months, and 6-month follow-up
Smoking Reduction Rate
Defined as a reduction in daily cigarette consumption by ≥50% compared to baseline levels.
Time frame: 1 week, 1 month, 3 months, and 6-month follow-up
Change in Smoking Self-Efficacy
Measured using the Smoking Self-Efficacy Questionnaire (SEQ-12). The scale contains 12 items rated on a 5-point Likert scale. Total scores range from 12 to 60, with higher scores indicating greater confidence in the ability to refrain from smoking in various situations.
Time frame: Baseline, 1 week, 1 month, 3 months, and 6-months follow-up
Change in Quality of Life
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The EQ-5D-5L assesses five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses will be converted to an EQ-5D-5L index score using the prespecified value set, with higher scores indicating better health-related quality of life. The outcome will be reported as the change in EQ-5D-5L index score from baseline.
Time frame: Baseline,1 week, 1 month, 3 months, and 6-months follow-up
Total Duration of AI Agent Use
AI agent use will be assessed using automatically recorded backend system logs. The cumulative duration of AI agent use for each participant during the follow-up period will be calculated. The unit of measure is minutes.
Time frame: From randomization through 6 months
Mean AI Agent Response Time
Mean AI agent response time will be calculated using backend system timestamps as the average time between submission of a participant message and generation of the corresponding AI agent response. The unit of measure is seconds.
Time frame: From randomization through 6 months
Mean AI Agent Session Duration
Mean session duration will be calculated from backend system logs as the total duration of AI agent use divided by the number of usage sessions for each participant. The unit of measure is minutes per session.
Time frame: From randomization through 6 months
No study locations are listed for this record.
Plan to share: Yes — The data will be shared one year after the results of the study'are published. The researchers can access the data by contacting the PI at xiaw23@mail.sysu.edu.cn with the research purpose described.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: One year after the results of the study are published
Access criteria: The researchers can access the data by contacting the PI at xiaw23@mail.sysu.edu.cn with the research purpose described.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Aug 2027, 10 months later.
Of 546 non-industry interventional studies with no phase under Smoking Cessation, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's planned 10 months is below that.
Counting every sponsor, half of 563 studies reached it within 24 months; a quarter within 12 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.