Smoking Cessation Among Underserved Patients Referred for Lung Cancer Screening: A Randomized Clinical Trial

The Centers for Medicare & Medicaid Services requires that health systems offer smoking cessation services to patients undergoing lung cancer screening. However, the most effective methods to achieve smoking cessation among medically underserved patients undergoing lung cancer screening are unknown.

To compare the effectiveness of 4 strategies for promoting smoking cessation among medically underserved persons referred for lung cancer screening.

This randomized clinical trial included currently smoking individuals referred for lung cancer screening at 4 US health systems (5 centers) who identified as Black, Hispanic, living in a rural area, or being of low socioeconomic status. The first participant was enrolled on May 17, 2021, and the date of last follow-up was April 29, 2025.

Patients were randomized to 1 of 4 groups. Participants received either an ask-advise-refer strategy to smoking cessation services (usual care); usual care plus free pharmacotherapy (ie, nicotine replacement and reimbursement for varenicline or bupropion); usual care, free pharmacotherapy, and financial incentives up to $600 contingent on biochemically confirmed smoking cessation; or usual care, free pharmacotherapy, and financial incentives plus a mobile health tool motivating patients to think about their future health.

The primary end point was biochemically confirmed, sustained tobacco abstinence through 6 months, measured with cotinine, anabasine, or carboxyhemoglobin.

Of the 9963 patients assessed for eligibility, 3259 patients were randomized and 3220 were included in the primary analysis. The median (IQR) age was 61.1 (56.6-66.0) years, 1948 (60.3%) were female, 823 (25.5%) were Black, 287 (8.9%) were Hispanic, 1251 (38.8%) lived in rural areas, 1519 (74.9%) had low socioeconomic status, and 1792 (55.5%) reported smoking more than 10 cigarettes per day at enrollment. Sustained tobacco abstinence rates through 6 months were 4.3% with usual care, 5.1% with the addition of pharmacotherapy, 8.8% with the addition of financial incentives, and 7.2% with the addition of mobile health tool. Adding financial incentives increased the adjusted rate of sustained tobacco abstinence compared with usual care (difference, 4.6% [95% CI, 2.1%-7.0%]; P < .001) and usual care plus free pharmacotherapy (difference, 4.1% [95% CI, 1.7%-6.4%]; P < .001). Adding free pharmacotherapy to ask-advise-refer was not superior to ask-advise-refer alone (difference, 0.5% [95% CI, -1.7% to 2.6%]; P = .66).

Among medically underserved adults who currently smoked cigarettes and were referred for lung cancer screening, rates of sustained tobacco abstinence were higher through 6 months with addition of financial incentives compared with ask-advise-refer alone or with addition of free pharmacotherapy.

ClinicalTrials.gov Identifier: NCT04798664.