Testing the effectiveness of a virtual sustained tobacco treatment: Initial reporting of findings from the EAQ171CD randomized clinical trial conducted by ECOG-ACRIN within the NCI Community Oncology Research Program (NCORP).

376 Background: Persistent smoking among patients diagnosed with cancer is associated with adverse clinical outcomes, yet clinical guidelines for tobacco use interventions have not been integrated into community oncology settings. We conducted a trial of a virtual sustained tobacco treatment intervention across community oncology settings nationally. Methods: This randomized clinical trial, conducted through ECOG-ACRIN, compared the effectiveness of sustained telehealth counseling plus medication (Virtual Sustained Treatment; VST) to referral to the NCI quitline (Enhanced Usual Care; EUC) in assisting recently diagnosed cancer patients to quit smoking. The VST group received up to 11 synchronous telehealth sessions (4 weekly, 4 biweekly, 3 monthly) of motivational counseling and up to 12-weeks of free NRT patch and/or lozenge. Eligibility criteria included adults within 4 months of a new cancer diagnosis, cigarette use in the past 30 days, English/Spanish speaking, and access to an internet-enabled device. The primary outcome is 6-month self-reported 7-day point prevalence abstinence. Results: From 08/2019 to 12/2022, 306 patients were randomized from 30 NCORP Community Sites and 7 Minority/Underserved NCORP sites. Participants were 70.9% female; 86.3% White; 8.8% Black; and 2.9% Hispanic; median age 57 years; 25.5% completed a college degree; 50.3% stages 0-2; 46.4% had non-smoking-related tumors. Median cigarettes per day was 12.0; 72.2% (n = 221/306) smoked within 30 minutes of waking; 49.0% (n = 150/306) were in precontemplation/contemplation stage of readiness to quit. 73.8% (222/301) and 72.2% (210/291) completed the 3 and 6-month outcome assessments. Classifying missing smoking status as smokers, 6-month abstinence rates were 28.4% (42/148) in the VST group vs. 14.7% (21/143) in the EUC group (p<.005). For secondary outcomes, there were no significant differences when adjusted for multiple comparisons (α = 0.0025); abstinence at 3-months was 24.7% (38/154) in the VST group vs. 15.0% (22/147) in the EUC group (p=.035); continuous abstinence at 6 months was 18.9% (28/148) in the VST vs 9.1% (13/143) in the EUC (p=.016). 80.8% (126/156) of individuals randomized to VST participated in counseling; of those, 59.5% (75/126) completed at least 6 sessions, 46.0% (58/126) completed at least one monthly booster session, and 85.7% (108/126) were dispensed 4 weeks of NRT. Conclusions: Among recently diagnosed cancer patients, sustained remotely delivered telehealth counseling and free NRT produced a significantly higher 6-month quit rate than a quitline referral. Findings support adopting a policy of widespread sustained tobacco treatment and implementation of tobacco treatment into community oncology care settings nationwide. Clinical trial information: NCT03808818 .