Background: Lung cancer screening and tobacco treatment for patients at high-risk for lung cancer may greatly reduce mortality from smoking, and there is an urgent need to improve smoking cessation therapies for this population.
Aims: The purpose of this study is to test the efficacy of two separate, sequential interventions to promote tobacco cessation/reduction compared to standard care in smokers considered high-risk for lung cancer.
Methods: The study will recruit 276 current smokers attending a lung cancer screening clinic or considered high-risk for lung cancer based on age and smoking history across two sites. Patients first will be randomized to either standard tobacco treatment (8 weeks of nicotine patch and five individual counselling sessions) or standard tobacco treatment plus personalized gain-framed messaging. At the 8-week visit, all patients will be re-randomized to receive biomarker feedback or no biomarker feedback. Repeated assessments during treatment will be used to evaluate changes in novel biomarkers: skin carotenoids, lung function, and plasma bilirubin that will be used for biomarker feedback. We hypothesize that personalized gain-framed messages and receiving biomarker feedback related to tobacco cessation/reduction will improve quit rates and prevent relapse compared to standard care. Primary outcomes include 7-day point-prevalence abstinence verified with expired carbon monoxide at 8 weeks and mean cigarettes per day in the past week at 6 months.
Conclusions: Study findings will inform the development of novel interventions for patients at risk for lung cancer to improve smoking cessation rates.