Construction and Effectiveness of a Multi-Theory Model-Based AI Agent Intervention for Smoking Cessation Among Early-Stage Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 156
- 主要终点
- Biochemically validated 7-Day Point Prevalence Abstinence Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
AI Agent Intervention Group
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.
干预措施: MTM-Based AI Agent for smoking cessation (Behavioral)
Counseling Group
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.
干预措施: Counseling (Behavioral)
Health Education Group
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).
结局指标
主要结局
Biochemically validated 7-Day Point Prevalence Abstinence Rate
时间窗: 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
次要结局
- 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)
- Mean AI Agent Response Time(From randomization through 6 months)
- Mean AI Agent Session Duration(From randomization through 6 months)
研究者
Wei XIA, PhD
Associate Professor
Sun Yat-sen University