Multi-Theory Model-Based AI Agent Intervention for Smoking Cessation in Early-Stage Cancer Patients

NCT07827066 | Not Yet Recruiting

• 1 other identifier: L2025SYSU-HL-048
• Study Type: interventional
• Target: 156
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Smoking Cessation; Early-Stage Cancer; AI Agent

Keywords

AI Agent; Multi-Theory Model; Tobacco Cessation; Mobile Health

Outcome Measures

Primary Outcomes (1)

• 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

  6 month follow-up after randomization

Secondary Outcomes (7)

• Self-Reported 7-Day Point Prevalence Abstinence Rate

  1 week, 1 month, 3 months, and 6-month follow-up

• Smoking Reduction Rate

  1 week, 1 month, 3 months, and 6-month follow-up

• Change in Smoking Self-Efficacy

  Baseline, 1 week, 1 month, 3 months, and 6-months follow-up

• Change in Quality of Life

  Baseline,1 week, 1 month, 3 months, and 6-months follow-up

• Total Duration of AI Agent Use

  From randomization through 6 months

Study Arms (3)

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.

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.

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).

Interventions

MTM-Based AI Agent for smoking cessation BEHAVIORAL

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.

AI Agent Intervention Group

Counseling BEHAVIORAL

WeChat-based counseling provided by smoking cessation specialists twice a month, following WHO guidelines.

Counseling Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

MeSH Terms

Conditions

Smoking Cessation; Neoplasms; Tobacco Use Cessation

Interventions

Counseling

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Wei Xia, PhD

CONTACT

8618823359471; xiaw23@mail.sysu.edu.cn

Jiebing Luo

CONTACT

8618885639072; luojiebing2002@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: September 18, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.