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Not Yet Recruiting NCT07827066

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

Conditions: Smoking Cessation, Early-Stage Cancer, AI Agent

Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 156
Sponsor: Sun Yat-sen University

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.

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07827066). StuddyBuddy aggregates publicly available trial information.