Study protocol for a telephone-based smoking cessation randomized controlled trial in the lung cancer screening setting: The lung screening, tobacco, and health trial
Study protocol for a telephone-based smoking cessation randomized controlled trial in the lung cancer screening setting: The lung screening, tobacco, and health trial
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DOI：
10.1016/j.cct.2019.05.006
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发表时间：
2019-07-01
影响因子：
2.2
通讯作者：
Anderson, Eric
中科院分区：
文献类型：
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作者：
Taylor, Kathryn L.;Deros, Danielle E.;Anderson, Eric
通过低剂量 CT 肺癌筛查 (LCS) 和早期疾病治疗，可将肺癌死亡率降低 20%。在 LCS 环境中向高风险吸烟者提供烟草使用治疗可能会带来超出 LCS 影响的健康益处。作为美国国家癌症研究所肺部检查戒烟 (SCALE) 合作的九项试验之一，肺部筛查、烟草和健康 (LSTH) 试验的目标是开发一种可扩展且具有成本效益的戒烟干预措施，供 LCS 项目随后实施。在 RE-AIM 框架的指导下，LSTH 试验是一项双臂随机对照试验 (N = 1330)，招募在七个合作地点之一注册 LCS 的讲英语和西班牙语的吸烟者。参与者被随机分配到常规护理组（UC；三次主动电话咨询会议/两周尼古丁贴片）与强化电话咨询组（ITC；八次主动电话咨询会议/八周尼古丁贴片，加上 LCS 结果的讨论以增加戒烟动机）。电话咨询由烟草治疗专家提供。为了提高护理的连续性，转诊医生会在干预后收到有关参与者入组和吸烟状况的通知。结果包括：1) 自我报告的 7 天、30 天和持续戒断情况，以及随机化后 3、6 和 12 个月的生化验证，2) 干预措施的覆盖范围和参与度，以及 3) 干预措施的成本效益。癌症干预和监测建模网络 (CISNET) 将模拟六项 SCALE 试验对每生命年节省成本、质量调整生命年节省、肺癌死亡率降低和人口死亡率的长期影响。
Lung cancer mortality can be reduced by 20% via low dose CT lung cancer screening (LCS) and treatment of early-stage disease. Providing tobacco use treatment to high risk cigarette smokers in the LCS setting may result in health benefits beyond the impact of LCS. As one of the nine trials in the National Cancer Institute's Smoking Cessation at Lung Examination (SCALE) collaboration, the goal of the Lung Screening, Tobacco, and Health (LSTH) trial is to develop a scalable and costeffective cessation intervention for subsequent implementation by LCS programs. Guided by the RE-AIM Framework, the LSTH trial is a two-arm RCT (N = 1330) enrolling English- and Spanish-speaking smokers registered for LCS at one of seven collaborating sites. Participants are randomly assigned to Usual Care (UC; three proactive telephone counseling sessions/two weeks of nicotine patches) vs. Intensive Telephone Counseling (ITC; eight proactive sessions/eight weeks of nicotine patches, plus discussion of the LCS results to increase motivation to quit). Telephone counseling is provided by tobacco treatment specialists. To increase continuity of care, referring physicians are notified of participant enrollment and smoking status following the intervention. Outcomes include: 1) self-reported 7-day, 30-day, and sustained abstinence, and biochemically-verified at 3-, 6-, and 12-months post-randomization, 2) reach and engagement of the interventions, and 3) cost-effectiveness of the interventions. The Cancer Intervention and Surveillance Modeling Network (CISNET) will model long-term impacts of six SCALE trials on the cost per life year saved, quality-adjusted life years saved, lung cancer mortality reduction, and population mortality.