Adaptive Interventions for Smoking Cessation in Lung Cancer Screening Programs

 描述（由申请人提供）：临床试验已经证明了行为，药理学和联合治疗策略对戒烟的有效性，但这些治疗方法的长期戒烟率低得令人沮丧。烟草依赖是一种慢性疾病，这一共识正在形成，但戒烟的慢性疾病管理模式尚未开发。从业人员缺乏关于如何随着时间的推移管理戒烟治疗的指导。适应性干预措施非常适合烟草依赖等疾病，其中患者对治疗的反应各不相同，治疗的有效性可能会随着时间的推移而变化，复发很常见。序贯、多重分配、随机试验（SMART）是一种严格比较不同适应性干预效果的新方法。我们提出了一个SMART，以确定戒烟治疗的最佳顺序，吸烟者对一线治疗（8周尼古丁替代治疗咨询）的反应不完全（戒烟日期后的任何吸烟）和完全，在肺癌筛查计划的设置中进行。美国预防服务工作组建议筛查肺癌高危人群（基于年龄和吸烟史），这使得临床上必须建立有效和有效的系统来大规模治疗吸烟者。我们的团队最近证明了一种戒烟的适应性干预措施的有效性，烟草纵向护理（TLC），提供为期一年的咨询和尼古丁替代治疗，并为戒烟困难或戒烟和复发的吸烟者提供计划。在本提案中，我们的主要目的是测试自适应TLC治疗的有益效果是否可以通过策略性增加药剂师辅助获得处方药安非他酮或伐尼克兰（药物治疗管理）来增强。将使用明尼苏达大学和明尼阿波利斯弗吉尼亚州的电子病历（N=1000）确定有资格接受肺癌筛查的当前吸烟者。所有参与者将接受为期8周的循证一线戒烟治疗。在一年的吸烟干预期间，参与者将有资格进行三次潜在的随机化：1）在4周与8周时确定对治疗的早期反应的时间（所有 参与者），2）基于电话的烟草纵向护理（TLC）与TLC加药剂师管理的药物治疗管理（一线治疗的不完全应答者，主要目的），以及3）每月TLC联系与季度TLC联系（一线治疗的完全应答者，次要目的）。主要结局将是治疗开始后18个月测量的6个月的长期禁欲。次要和探索性目的的分析将包括潜在的调节因素，如治疗缓解量和肺癌筛查结果。SMART的结果将为数百万目前吸烟者的戒烟治疗强度和顺序提供信息，这些吸烟者将每年接受低剂量CT扫描以治疗肺癌。

 DESCRIPTION (provided by applicant): Clinical trials have demonstrated the efficacy of behavioral, pharmacological, and combination treatment strategies for smoking cessation, but these treatments yield frustratingly low rates of long-term abstinence. There is emerging consensus that tobacco dependence is a chronic condition, but chronic disease management models for smoking cessation are under-developed. Practitioners have scant guidance regarding how to manage cessation treatment over time. Adaptive interventions are well-suited to conditions like tobacco dependence where patients vary in response to treatment, effectiveness of treatment may change over time, and relapse is common. Sequential, multiple assignment, randomized trials (SMART) are a novel method to rigorously compare different adaptive intervention effects. We propose a SMART to identify the optimal sequence of smoking cessation treatments for smokers who respond both incompletely (any smoking after quit date) and completely to first-line treatment (8 weeks of counseling with nicotine replacement therapy), conducted in the setting of lung cancer screening programs. The U.S. Preventive Services Task Force recommendation to screen persons at high risk for lung cancer (based on age and smoking history) creates a clinical imperative to establish efficient and effective systems to trea smokers on a large scale. Our team recently demonstrated the efficacy of one adaptive intervention for smoking cessation, Tobacco Longitudinal Care (TLC), that provides counseling and nicotine replacement therapy for one year, incorporating plans for smokers who have difficulty quitting or quit and relapse. In this proposal, our primary aim is to test whether the beneficial effect of adaptive TLC treatment can be augmented by the strategic addition of pharmacist-assisted access to the prescription medications bupropion or varenicline (Medication Therapy Management). Current smokers who are eligible for lung cancer screening will be identified using the electronic medical record at the University of Minnesota and Minneapolis VA (N=1000). All participants will receive 8 weeks of evidence-based first-line smoking cessation treatment. Participants will be eligible for three potential randomizations during one year of smoking intervention: 1) to timing of identifying early response to treatment at 4 vs. 8 weeks (all participants), 2) to telephone-based tobacco longitudinal care (TLC) vs. TLC plus pharmacist-administered Medication Therapy Management (incomplete responders to first-line treatment, Primary Aim), and 3) to monthly TLC contact vs. quarterly TLC contact (complete responders to first-line treatment, Secondary Aim). The primary outcome will be 6 months of prolonged abstinence measured 18 months after the beginning of treatment. Analyses for secondary and exploratory aims will include potential moderators such as amount of response to treatment and lung cancer screening results. Results from this SMART will inform decisions regarding the intensity and sequence of smoking cessation treatments for millions of current smokers who will undergo annual low-dose CT scanning for lung cancer.