Program for lung cancer screening and tobacco cessation: Study protocol of a sequential, multiple assignment, randomized trial

Abstract

PLUTO will conduct a sequential, multiple assignment, randomized trial to inform the choice and delivery of smoking cessation treatments for smokers in the setting of lung cancer screening, including for smokers who respond both incompletely (any smoking after quit date) and completely to first-line treatment (4 or 8 weeks of counseling with nicotine replacement therapy). Currently, there is little evidence to guide the development of adaptive interventions in tobacco cessation. SMART designs, such as the one we propose, are an ideal experimental design to assess different adaptive intervention strategies. Adaptive interventions for smoking cessation in the context of lung cancer screening have high potential for dissemination and impact. The USPSTF recommends annual low-dose CT screening for patients at high risk Recommendation (Grade B)4; private insurance coverage is mandated for USPSTF Grade A or B recommendations. The Affordable Care Act (ACA) mandates coverage of preventative services including smoking cessation treatment. The ACA requires coverage of at least 2 quit attempts/year, 4 counseling sessions of at least 10 minutes, and all Food and Drug Administration (FDA) approved tobacco cessation meds for a 90 day treatment regimen when prescribed by a health care provider (7 medications: 5 forms of NRT, bupropion, and varenicline).74 Effective smoking cessation treatment, delivered in the context of lung cancer screening programs, may augment the mortality benefit of imaging studies. The novel tobacco treatment system we plan – identification of smokers by using the EMR and proactive invitation to treatment coupled with lung cancer screening – is an opportunity to engage a new cohort of smokers with mechanisms in place to implement delivery of care. Thus, the PLUTO trial takes advantage of a new clinical practice development: recommendation for annual lung cancer screening based on age and smoking history. Strengths are an innovative study design and sequential random assignment of treatment conditions in addition to the main comparative effectiveness outcome that allows more rigorous measurement of effects than a standard randomized controlled trial would afford. The information about timing of assessment, optimal intervention components, and intensity of treatment are ripe for dissemination.