Jordan M Neil1, Caylin Marotta2, Irina Gonzalez3, Yuchiao Chang2, Douglas E Levy4, Amy Wint2, Kimberly Harris2, Saif Hawari3, Elise Noonan3, Grace Styklunas3, Sydney Crute3, Sydney E Howard5, Joanne Sheppard6, Inga T Lennes6, Francine Jacobson7, Efren J Flores8, Jennifer S Haas5, Elyse R Park9, Nancy A Rigotti10. 1. Department of Family and Preventive Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States of America; TSET Health Promotion Research Center, Stephenson Cancer Center, Oklahoma City, OK, United States of America; Health Promotion and Resiliency and Intervention Research Program; Mongan Institute Health Policy Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America. Electronic address: Jordan-Neil@ouhsc.edu. 2. Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America. 3. Health Promotion and Resiliency and Intervention Research Program; Mongan Institute Health Policy Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America. 4. Health Promotion and Resiliency and Intervention Research Program; Mongan Institute Health Policy Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America; Tobacco Research and Treatment Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America. 5. Health Promotion and Resiliency and Intervention Research Program; Mongan Institute Health Policy Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America; Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America. 6. Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America. 7. Department of Radiology, Brigham and Women's Faulkner Hospital, Harvard Medical School, Boston, MA, United States of America. 8. Health Promotion and Resiliency and Intervention Research Program; Mongan Institute Health Policy Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America; Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America. 9. Health Promotion and Resiliency and Intervention Research Program; Mongan Institute Health Policy Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America; Tobacco Research and Treatment Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America; Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America. 10. Health Promotion and Resiliency and Intervention Research Program; Mongan Institute Health Policy Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America; Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America; Tobacco Research and Treatment Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.
Abstract
BACKGROUND: Integrating tobacco treatment services into lung cancer screening (LCS) has the potential to leverage a 'teachable moment' to promote cessation among long-term smokers and reduce disparities in tobacco treatment access. This protocol paper describes the Screen ASSIST (Aiding Screening Support In Stopping Tobacco) trial, which will identify how to best deliver evidence-driven tobacco treatment in the context of LCS. METHODS: Screen ASSIST is a randomized clinical trial with a 3-factor, fully crossed factorial design that enrolls current smokers (any cigarette use in the past 30 days) scheduled to attend LCS at multiple sites in the Mass General Brigham healthcare system. To maximize reach, recruitment is conducted at 3 time points: 1) at the time of LCS scheduling, 2) at the LCS visit, and 3) after the participant has received their LCS results. Participants are stratified by LCS study site and recruitment point and randomly assigned into 8 groups that test intervention components varying on telehealth counseling duration (4 weeks vs. 8 weeks), nicotine replacement therapy duration (2 weeks vs. 8 weeks), and systematic screening and referral for social determinants of health via a service named 'AuntBertha' (referral vs. no referral). The primary study outcome is self-reported past 7-day tobacco abstinence at 6-month follow-up. This trial will also assess systems integration and evaluate implementation of the intervention. DISCUSSION: Screen ASSIST will identify the most effective combination of tobacco cessation treatments within the LCS context, in order to improve the cost-effectiveness of LCS and quality of life among long-term heavy smokers.
BACKGROUND: Integrating tobacco treatment services into lung cancer screening (LCS) has the potential to leverage a 'teachable moment' to promote cessation among long-term smokers and reduce disparities in tobacco treatment access. This protocol paper describes the Screen ASSIST (Aiding Screening Support In Stopping Tobacco) trial, which will identify how to best deliver evidence-driven tobacco treatment in the context of LCS. METHODS: Screen ASSIST is a randomized clinical trial with a 3-factor, fully crossed factorial design that enrolls current smokers (any cigarette use in the past 30 days) scheduled to attend LCS at multiple sites in the Mass General Brigham healthcare system. To maximize reach, recruitment is conducted at 3 time points: 1) at the time of LCS scheduling, 2) at the LCS visit, and 3) after the participant has received their LCS results. Participants are stratified by LCS study site and recruitment point and randomly assigned into 8 groups that test intervention components varying on telehealth counseling duration (4 weeks vs. 8 weeks), nicotine replacement therapy duration (2 weeks vs. 8 weeks), and systematic screening and referral for social determinants of health via a service named 'AuntBertha' (referral vs. no referral). The primary study outcome is self-reported past 7-day tobacco abstinence at 6-month follow-up. This trial will also assess systems integration and evaluate implementation of the intervention. DISCUSSION: Screen ASSIST will identify the most effective combination of tobacco cessation treatments within the LCS context, in order to improve the cost-effectiveness of LCS and quality of life among long-term heavy smokers.
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