Integrating Evidence-Based Smoking Cessation Interventions into Lung Cancer Screening Programs: A Randomized Trial

摘要 通过CT筛查和早期疾病治疗，肺癌死亡率可降低20%。只有在接受肺部筛查的高危吸烟者得到戒烟帮助的情况下，筛查才能实现最大的健康影响。虽然已知有几种有效的戒烟干预措施，但其中许多都不能在各种基于社区的肺癌筛查计划中推广，也不能在不寻求戒烟治疗的吸烟者中推广。我们的目标是开发一种可扩展的、具有成本效益的戒烟干预措施，以便广泛实施，为个人和社会带来最大的好处和最低的成本。在RE-AIM框架的指导下，我们提出了一个务实的电话咨询RCT，设计在可伸缩性和强度的交叉点上，用于未来在全国烟草戒烟线内的实施。我们经验丰富的团队将对在5个不同筛查地点登记进行筛查的1330名吸烟者进行随机试验，比较：1)常规护理(UC)：电话咨询，其中吸烟者接受最多3次咨询和免费NRT的标准方案；2)多方面、8次会议、强化电话咨询(ITC)方案，根据筛查结果量身定做，免费NRT。双方都会收到戒烟的简短建议，初级保健参与，包括说英语和西班牙语的人，烟草治疗专家将进行电话咨询。ITC分支机构的目标是利用肺部筛查的可教时刻提供的增加的动机，并抵消在正常结果后戒烟动机降低的可能性。此外，我们方法的两个重要方面包括成本效益分析和使用癌症干预和监测建模网络(CISNET)来评估干预成本对与吸烟相关的短期和长期结果的影响。通过纳入所有吸烟者，无论他们是否愿意戒烟，个性化他们与烟草相关的健康风险，并提供基于证据的戒烟干预措施，我们预计ITC的分支机构将产生显著更高的戒烟率，具有广泛实施的良好潜力，从而产生具有成本效益的干预措施。其目的是：1)比较强化电话咨询(ITC)和常规护理(UC)标准电话咨询在经过生化验证的7天、30天和持续禁欲方面的差异。将对干预调解人和主持人进行评估。2)评估干预措施的覆盖范围和参与度。3)对ITC和UC进行成本-效果分析，以每3个月、6个月和12个月的戒毒率和戒烟尝试的成本为依据。该模型将预测干预措施对每一寿命年节省的成本和经质量调整的节省的寿命年、降低肺癌死亡率和总体人口死亡率的长期影响。这项研究将通过提供关键数据来解决筛查中心、保险公司和政策制定者的可扩展性努力，从而对公共卫生产生重大影响。

Abstract Lung cancer mortality can be reduced by 20% via CT screening and treatment of early stage disease. Maximum health impact from screening will only be achieved if high-risk smokers undergoing lung screening receive assistance to stop smoking. While there are several known effective cessation interventions, many of these are not scalable within diverse community-based lung cancer screening programs or with smokers who are not seeking cessation treatment. Our goal is to develop a scalable and cost-effective cessation intervention for widespread implementation to yield the greatest benefits and the lowest costs to both individuals and society. Guided by the RE-AIM Framework, we are proposing a pragmatic telephone counseling RCT, designed at the intersection of scalability and intensity, for future implementation within the national tobacco quitline. Our experienced team will conduct a randomized trial of 1330 smokers who have registered for screening at 5 diverse screening sites, comparing: 1) usual care (UC): telephone counseling, in which smokers receive a standard protocol of up to 3 counseling sessions and free NRT, vs. 2) a multi-faceted, 8-session, intensive telephone counseling (ITC) protocol, tailored on screening result, with free NRT. Both arms receive brief advice to quit, with primary care engagement, both English and Spanish speakers are included, and tobacco treatment specialists will conduct the telephone counseling. The goal of the ITC arm is to leverage the increased motivation provided by the teachable moment of lung screening and to counteract the potential for reduced motivation to quit following a normal result. Further, two important aspects of our approach include a cost-effectiveness analysis and use of the Cancer Intervention and Surveillance Modeling Network (CISNET) to evaluate the costs of the interventions relative to their impact on short- and long-term smoking-related outcomes. By including all smokers, regardless of readiness to quit, personalizing their tobacco-related health risks, and providing an evidence-based cessation intervention, we expect that the ITC arm will yield substantially higher quit rates with excellent potential for widespread implementation, resulting in a cost-effective intervention. The aims are: 1) To compare intensive telephone counseling (ITC) vs. usual care (UC) standard telephone counseling on biochemically verified 7-day, 30-day, and sustained abstinence. Intervention mediators and moderators will be assessed. 2) To evaluate reach and engagement of the interventions. 3) To conduct a cost-effectiveness analysis of ITC vs UC, in terms of cost per 3-, 6- and 12-month abstinence rates and quit attempts. The CISNET model will project the long-term impact of the interventions on cost per life year saved and quality-adjusted life years saved, lung cancer mortality reduction, and overall population mortality. This study will have a substantial public health impact by providing critical data to address scalability efforts by screening centers, insurers, and policy-makers.