Reach, Acceptability, and Effectiveness of Proactive Outreach and Varenicline With Cancer-Focused Counseling for Patients With Cancer: A Pilot Randomized Comparative Effectiveness Trial

PURPOSE More research is needed on the acceptability and effectiveness of cigarette smoking cessation treatments for patients with cancer. This pilot comparative effectiveness trial contrasted varenicline therapy combined with cancer-focused counseling versus standard smoking cessation treatment to assess the reach, acceptability, and preliminary effectiveness of targeted treatment offered proactively to adult patients with cancer. METHODS Electronic health records identified adult patients via quarterly reports (January-September, 2024) with cancer diagnoses who smoked tobacco in the past year (N = 574) for tobacco use treatment outreach. Eligible patients were enrolled from March to November, 2024, in an effectiveness trial comparing standard smoking cessation treatment (2 weeks of nicotine patch + 3 counseling calls) with enhanced treatment (12 weeks of varenicline + 7 cancer-targeted counseling calls). Follow-up outcome calls were conducted 12 and 26 weeks after a target quit date. Participants reporting no smoking at 26 weeks postquit were asked to provide a saliva or breath sample to confirm abstinence. RESULTS Among patients eligible at the time of phone outreach (n = 406), 52 (12.8%) were enrolled in the trial. In both Standard Care (n = 26) and Enhanced Care (n = 26), at least 23 (88.5%) participants completed some counseling and received study medications. Satisfaction ratings were higher in Enhanced than Standard Care. At 12 weeks postquit, self-reported 7-day point-prevalence abstinence was reported by six (23.1%) Standard Care and nine (34.6%) Enhanced Care participants (odds ratio OR, 1.76 95% CI, 0.52 to 5.97). At 26-weeks postquit, two (7.7%) Standard Care and seven (26.9%) Enhanced Care participants had biochemically confirmed abstinence (OR, 4.4 95% CI, 0.82 to 23.8). CONCLUSION This pilot study produced evidence supporting the reach, acceptability, and potential effect sizes of enhanced and cancer-focused smoking cessation counseling and medication treatment for adult patients with cancer.