Smoking CessationNCT07827066
Multi-Theory Model-Based AI Agent Intervention for Smoking Cessation in Early-Stage Cancer Patients
A study testing MTM-Based AI Agent for smoking cessation and Counseling in people with Smoking Cessation and Early-Stage Cancer, run by Sun Yat-sen University.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Smoking Cessation, Early-Stage Cancer, AI Agent
- What is being tested?
- MTM-Based AI Agent for smoking cessation and Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥18 years, diagnosed with early-stage cancer (AJCC 8th edition clinical stage cTNM 0-II);
- Smoked in the past 30 days, with an average daily consumption of > 1 cigarette, and an exhaled Carbon Monoxide (CO) level ≥ 4 ppm;
- Able to communicate using WeChat;
- Able to understand and read Chinese, and possess conversational Mandarin skills;
- Willing to participate in this study and sign the informed consent form.
Who cannot join
- Individuals who are unable to communicate due to severe mental or physical illness;
- Individuals currently participating in other tobacco control research projects;
- Individuals whose cancer has metastasized.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Construction and Effectiveness of a Multi-Theory Model-Based AI Agent Intervention for Smoking Cessation Among Early-Stage Cancer Patients
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?
Read more
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
- Smoking Cessation, Early-Stage Cancer, AI Agent
- Being tested
- MTM-Based AI Agent for smoking cessation, Counseling
- Keywords
- AI Agent, Multi-Theory Model, Tobacco Cessation, Mobile Health
- Medical subject headings
- Smoking Cessation, Neoplasms, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTM-Based AI Agent for smoking cessationBehavioural
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.
CounselingBehavioural
WeChat-based counseling provided by smoking cessation specialists twice a month, following WHO guidelines.
| Study group | Role | What they receive |
|---|---|---|
| AI Agent Intervention Group | Experimental | 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. Receives: Behavioral: MTM-Based AI Agent for smoking cessation |
| Counseling Group | Active comparator | 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. Receives: Behavioral: Counseling |
| Health Education Group | No intervention | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 month follow-up after randomization
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From randomization through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a three-arm, parallel-group randomized controlled trial (RCT). Eligible participants will be randomized in a 1:1:1 ratio to one of three groups: the AI Agent intervention group, the professional counseling group (active control), or the routine health education group (blank control). All groups will receive their respective interventions (or standard care) concurrently and will be followed up for 6 months.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei XIA, PhD, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827066
- Sponsor's protocol ID
- L2025SYSU-HL-048
- Status last verified
- Sep 2026
- First submitted
- 28 Jul 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Effectiveness of a Multi-Theory Model-Based AI Agent Intervention for Smoking Cessation Among Early-Stage Cancer Patients
- ClinicalTrials.gov ID
- NCT07827066
- Acronym / sponsor ID
- L2025SYSU-HL-048
- Conditions
- Smoking Cessation, Early-Stage Cancer, AI Agent
- Keywords
- AI Agent, Multi-Theory Model, Tobacco Cessation, Mobile Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This study is a three-arm, parallel-group randomized controlled trial (RCT). Eligible participants will be randomized in a 1:1:1 ratio to one of three groups: the AI Agent intervention group, the professional counseling group (active control), or the routine health education group (blank control). All groups will receive their respective interventions (or standard care) concurrently and will be followed up for 6 months.
| Arm | Type | Receives |
|---|---|---|
| AI Agent Intervention Group | Experimental | Behavioral: MTM-Based AI Agent for smoking cessationParticipants 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. |
| Counseling Group | Active comparator | Behavioral: CounselingParticipants 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. |
| Health Education Group | No intervention | –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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years, diagnosed with early-stage cancer (AJCC 8th edition clinical stage cTNM 0-II);
- Smoked in the past 30 days, with an average daily consumption of > 1 cigarette, and an exhaled Carbon Monoxide (CO) level ≥ 4 ppm;
- Able to communicate using WeChat;
- Able to understand and read Chinese, and possess conversational Mandarin skills;
- Willing to participate in this study and sign the informed consent form.
Key exclusion criteria (3 listed)
- Individuals who are unable to communicate due to severe mental or physical illness;
- Individuals currently participating in other tobacco control research projects;
- Individuals whose cancer has metastasized.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MTM-Based AI Agent for smoking cessationAn 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. | Behavioural | AI Agent Intervention Group |
| CounselingWeChat-based counseling provided by smoking cessation specialists twice a month, following WHO guidelines. | Behavioural | Counseling Group |
Primary outcome
Biochemically validated 7-Day Point Prevalence Abstinence Rate
Time frame: 6 month follow-up after randomization
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
7 secondary outcomes
Self-Reported 7-Day Point Prevalence Abstinence Rate
Time frame: 1 week, 1 month, 3 months, and 6-month follow-up
Smoking Reduction Rate
Time frame: 1 week, 1 month, 3 months, and 6-month follow-up
Change in Smoking Self-Efficacy
Time frame: Baseline, 1 week, 1 month, 3 months, and 6-months follow-up
Change in Quality of Life
Time frame: Baseline,1 week, 1 month, 3 months, and 6-months follow-up
Total Duration of AI Agent Use
Time frame: From randomization through 6 months
Mean AI Agent Response Time
Time frame: From randomization through 6 months
Mean AI Agent Session Duration
Time frame: From randomization through 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing MTM-Based AI Agent for smoking cessation and Counseling in people with Smoking Cessation and Early-Stage Cancer, run by Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Xia, PhD (8618823359471, xiaw23@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically validated 7-Day Point Prevalence Abstinence Rate (time frame: 6 month follow-up after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.