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、药物和联合治疗策略对戒烟的有效性，但这些治疗方法产生的长期戒烟率低得令人沮丧。烟草依赖是一种慢性病，这一点正在形成共识，但戒烟的慢性病管理模式还不够发达。从业者对如何随着时间的推移管理戒烟治疗缺乏指导。适应性干预非常适合烟草依赖等情况，在这种情况下，患者对治疗的反应不同，治疗的有效性可能会随着时间的推移而改变，而且复发很常见。序贯、多任务、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。我们提出了一种SMART方法，为在肺癌筛查计划中进行的一线治疗(尼古丁替代疗法咨询8周)既有不完全反应(戒烟后任何吸烟)又完全有反应的吸烟者确定最佳戒烟治疗顺序。美国预防服务工作组建议对肺癌高危人群进行筛查(基于年龄和吸烟史)，建立高效有效的系统来大规模治疗吸烟者是临床上的当务之急。我们的团队最近展示了一种适应性戒烟干预措施的有效性，即烟草纵向护理(TLC)，它提供为期一年的咨询和尼古丁替代疗法，纳入了针对难以戒烟或戒烟和复发的吸烟者的计划。在这项提案中，我们的主要目的是测试适应性TLC治疗的有益效果是否可以通过战略性地增加处方药安非他酮或伐伦克林(药物治疗管理)的药剂师辅助获得而得到增强。目前有资格进行肺癌筛查的吸烟者将使用明尼苏达大学和明尼阿波利斯大学的电子医疗记录进行识别(N=1000)。所有参与者都将接受为期8周的循证一线戒烟治疗。参与者将有资格在一年的吸烟干预期间接受三个潜在的随机试验：1)确定治疗早期反应的时间在4周与8周(均为 2)电话烟草纵向护理(TLC)与TLC加药剂师管理的药物治疗管理(对一线治疗的不完全应答者，主要目标)，以及3)每月TLC联系与季度TLC联系(对一线治疗的完全应答者，次级目标)。主要结果将是在治疗开始后18个月测量的6个月的长期禁欲。对次级和探索性目标的分析将包括潜在的调节因素，如对治疗的应答量和肺癌筛查结果。SMART的结果将为数百万目前将接受每年低剂量肺癌CT扫描的吸烟者提供戒烟治疗强度和顺序的决策依据。

 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.