多阶段优化策略试验（MOST）研究方案：在肺癌筛查环境中提供戒烟治疗。

Study protocol of a multiphase optimization strategy trial (MOST) for delivery of smoking cessation treatment in lung cancer screening settings.

机构信息

Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 641 Lexington Ave., 7th Floor, New York, NY, 10022, USA.

School of Global Public Health, New York University, New York, USA.

出版信息

Trials. 2022 Aug 17;23(1):664. doi: 10.1186/s13063-022-06568-3.

DOI:10.1186/s13063-022-06568-3

PMID:35978334

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9383667/

Abstract

BACKGROUND

There is widespread agreement that the integration of cessation services in lung cancer screening (LCS) is essential for achieving the full benefits of LCS with low-dose computed tomography (LDCT). There is a formidable knowledge gap about how to best design feasible, effective, and scalable cessation services in LCS facilities. A collective of NCI-funded clinical trials addressing this gap is the Smoking Cessation at Lung Examination (SCALE) Collaboration.

METHODS

The Cessation and Screening to Save Lives (CASTL) trial seeks to advance knowledge about the reach, effectiveness, and implementation of tobacco treatment in lung cancer screening. We describe the rationale, design, evaluation plan, and interventions tested in this multiphase optimization strategy trial (MOST). A total of 1152 screening-eligible current smokers are being recruited from 18 LCS sites (n = 64/site) in both academic and community settings across the USA. Participants receive enhanced standard care (cessation advice and referral to the national Quitline) and are randomized to receive additional tobacco treatment components (motivational counseling, nicotine replacement patches/lozenges, message framing). The primary outcome is biochemically validated, abstinence at 6 months follow-up. Secondary outcomes are self-reported smoking abstinence, quit attempts, and smoking reduction at 3 and 6 months. Guided by the Implementation Outcomes Framework (IOF), our evaluation includes measurement of implementation processes (reach, fidelity, acceptability, appropriateness, sustainability, and cost).

CONCLUSION

We will identify effective treatment components for delivery by LCS sites. The findings will guide the assembly of an optimized smoking cessation package that achieves superior cessation outcomes. Future trials can examine the strategies for wider implementation of tobacco treatment in LDCT-LCS sites.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03315910.

摘要

背景

人们普遍认为，将戒烟服务纳入肺癌筛查（LCS）对于实现低剂量计算机断层扫描（LDCT）肺癌筛查的全部益处至关重要。在如何最好地设计可行、有效和可扩展的 LCS 戒烟服务方面，存在着巨大的知识差距。一个由 NCI 资助的临床试验团体正在解决这一差距，这就是“在肺部检查中戒烟（SCALE）”合作组织。

方法

“戒烟与筛查以拯救生命（CASTL）”试验旨在推进关于肺癌筛查中烟草治疗的可及性、有效性和实施情况的知识。我们描述了这个多阶段优化策略试验（MOST）的基本原理、设计、评估计划和测试干预措施。总共从美国的 18 个 LCS 站点（每个站点 64 名参与者）招募了 1152 名符合筛查条件的当前吸烟者（n = 64/站点），这些参与者来自学术和社区环境。参与者接受强化标准护理（戒烟建议和转诊到全国戒烟热线），并随机接受额外的烟草治疗干预（动机咨询、尼古丁替代贴片/口含剂、信息框架）。主要结果是在 6 个月随访时通过生物化学验证的戒烟。次要结果是在 3 个月和 6 个月时自我报告的戒烟、戒烟尝试和吸烟减少。根据实施结果框架（IOF），我们的评估包括对实施过程（可及性、一致性、可接受性、适宜性、可持续性和成本）的测量。