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.
Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.
Contemp Clin Trials. 2021 Dec;111:106586. doi: 10.1016/j.cct.2021.106586. Epub 2021 Oct 1.
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.
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.
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.
将烟草治疗服务整合到肺癌筛查(LCS)中,有可能利用“教学时刻”来促进长期吸烟者戒烟,并减少烟草治疗获取方面的差异。本方案文件描述了 Screen ASSIST(辅助筛查支持停止烟草)试验,该试验将确定如何在 LCS 背景下最好地提供循证烟草治疗。
Screen ASSIST 是一项随机临床试验,采用 3 因素完全交叉因子设计,在 Mass General Brigham 医疗保健系统的多个地点招募计划接受 LCS 的当前吸烟者(过去 30 天内有任何吸烟行为)。为了最大限度地扩大覆盖面,招募分 3 个时间点进行:1)在 LCS 预约时,2)在 LCS 就诊时,3)在参与者收到 LCS 结果后。参与者按 LCS 研究地点和招募点分层,并随机分为 8 组,测试干预组件在远程健康咨询持续时间(4 周与 8 周)、尼古丁替代疗法持续时间(2 周与 8 周)以及通过名为“AuntBertha”的服务进行系统筛查和社会决定因素转诊方面的差异(转诊与不转诊)。主要研究结果是在 6 个月随访时自我报告过去 7 天的烟草戒断情况。该试验还将评估系统整合情况,并评估干预措施的实施情况。
Screen ASSIST 将确定 LCS 背景下最有效的烟草戒烟治疗组合,以提高 LCS 的成本效益,并改善长期重度吸烟者的生活质量。