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

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. 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). 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. ClinicalTrials.gov NCT03315910.

Ostroff JS ，Shelley DR ，Chichester LA ，King JC ，Li Y ，Schofield E ，Ciupek A ，Criswell A ，Acharya R ，Banerjee SC ，Elkin EB ，Lynch K ，Weiner BJ ，Orlow I ，Martin CM ，Chan SV ，Frederico V ，Camille P ，Holland S ，Kenney J ... -  《Trials》

An integrated digital/clinical approach to smoking cessation in lung cancer screening: study protocol for a randomized controlled trial.

Graham AL ，Burke MV ，Jacobs MA ，Cha S ，Croghan IT ，Schroeder DR ，Moriarty JP ，Borah BJ ，Rasmussen DF ，Brookover MJ ，Suesse DB ，Midthun DE ，Hays JT ... -  《Trials》

Study protocol for a telephone-based smoking cessation randomized controlled trial in the lung cancer screening setting: The lung screening, tobacco, and health trial.

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 cost-effective 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. CLINICAL TRIALS REGISTRATION: The trial is registered at clinical trials.gov: NCT03200236.

Taylor KL ，Deros DE ，Fallon S ，Stephens J ，Kim E ，Lobo T ，Davis KM ，Luta G ，Jayasekera J ，Meza R ，Stanton CA ，Niaura RS ，Abrams DB ，McKee B ，Howell J ，Ramsaier M ，Batlle J ，Dornelas E ，Parikh V ，Anderson E ... -  《-》

Accelerating integration of tobacco use treatment in the context of lung cancer screening: Relevance and application of implementation science to achieving policy and practice.

Based on the findings from the National Lung Screening Trial, the U.S. Preventive Services Task Force recommends annual low dose computed tomography (LDCT) lung cancer screening (LCS) among high-risk adults. Approximately 54% of individuals seeking LCS report current cigarette smoking. Effective smoking cessation interventions, offered at the time of LCS, enhances the health benefits of screening that are attributable to reductions in lung cancer overall and tobacco-related mortality. Considering these data, the Centers for Medicare & Medicaid Services' (CMS) 2015 decision to cover LCS with LDCT required that radiology imaging facilities make tobacco cessation interventions available for people who smoke. In February 2022, CMS reversed their 2015 coverage requirement for delivering tobacco use treatment at the time of LDCT; CMS retained the requirement for counseling during the shared decision-making visit prior to the exam. The policy change does not diminish the importance of offering high-quality tobacco cessation services in conjunction with routine LDCT for LCS. However, LCS programs face a range of barriers to implementing tobacco use treatment in their settings. As a result, implementation has lagged. Closing the "evidence to practice" gap is the focus of implementation science, a field that offers a set of rigorous methods and a systematic approach to identifying and overcoming contextual barriers to implementing evidence-based guidelines in a range of clinical settings. In this paper, we describe how implementation science frameworks and methods can be used to help guide LCS programs in their efforts to integrate tobacco use treatment and discuss policy changes needed to further facilitate the delivery of TUT as an essential component of the LCS process.

Shelley D ，Wang VH ，Taylor K ，Williams R ，Toll B ，Rojewski A ，Foley KL ，Rigotti N ，Ostroff JS ... -  《-》

Integrating tobacco treatment into lung cancer screening practices: Study protocol for the Screen ASSIST randomized clinical trial.

Integrating tobacco treatment services into lung cancer screening (LCS) has the potential to leverage a 'teachable moment' to promote cessation among long-term smokers and reduce disparities in tobacco treatment access. This protocol paper describes the Screen ASSIST (Aiding Screening Support In Stopping Tobacco) trial, which will identify how to best deliver evidence-driven tobacco treatment in the context of LCS. Screen ASSIST is a randomized clinical trial with a 3-factor, fully crossed factorial design that enrolls current smokers (any cigarette use in the past 30 days) scheduled to attend LCS at multiple sites in the Mass General Brigham healthcare system. To maximize reach, recruitment is conducted at 3 time points: 1) at the time of LCS scheduling, 2) at the LCS visit, and 3) after the participant has received their LCS results. Participants are stratified by LCS study site and recruitment point and randomly assigned into 8 groups that test intervention components varying on telehealth counseling duration (4 weeks vs. 8 weeks), nicotine replacement therapy duration (2 weeks vs. 8 weeks), and systematic screening and referral for social determinants of health via a service named 'AuntBertha' (referral vs. no referral). The primary study outcome is self-reported past 7-day tobacco abstinence at 6-month follow-up. This trial will also assess systems integration and evaluate implementation of the intervention. Screen ASSIST will identify the most effective combination of tobacco cessation treatments within the LCS context, in order to improve the cost-effectiveness of LCS and quality of life among long-term heavy smokers.

Neil JM ，Marotta C ，Gonzalez I ，Chang Y ，Levy DE ，Wint A ，Harris K ，Hawari S ，Noonan E ，Styklunas G ，Crute S ，Howard SE ，Sheppard J ，Lennes IT ，Jacobson F ，Flores EJ ，Haas JS ，Park ER ，Rigotti NA ... -  《-》