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 ... -  《-》

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》

Preliminary evaluation of a telephone-based smoking cessation intervention in the lung cancer screening setting: A randomized clinical trial.

Incorporating effective smoking cessation interventions into lung cancer screening (LCS) programs will be essential to realizing the full benefit of screening. We conducted a pilot randomized trial to determine the feasibility and efficacy of a telephone-counseling (TC) smoking cessation intervention vs. usual care (UC) in the LCS setting. In collaboration with 3 geographically diverse LCS programs, we enrolled current smokers (61.5% participation rate) who were: registered to undergo LCS, 50-77 years old, and had a 20+ pack-year smoking history. Eligibility was not based on readiness to quit. Participants completed pre-LCS (T0) and post-LCS (T1) telephone assessments, were randomized to TC (N=46) vs. UC (N=46), and completed a final 3-month telephone assessment (T2). Both study arms received a list of evidence-based cessation resources. TC participants also received up to 6 brief counseling calls with a trained cessation counselor. Counseling calls incorporated motivational interviewing and utilized the screening result as a motivator for quitting. The outcome was biochemically verified 7-day point prevalence cessation at 3-months post-randomization. Participants (56.5% female) were 60.2 (SD=5.4) years old and reported 47.1 (SD=22.2) pack years; 30% were ready to stop smoking in the next 30 days. TC participants completed an average of 4.4 (SD=2.3) sessions. Using intent-to-treat analyses, biochemically verified quit rates were 17.4% (TC) vs. 4.3% (UC), p<.05. This study provides preliminary evidence that telephone-based cessation counseling is feasible and efficacious in the LCS setting. As millions of current smokers are now eligible for lung cancer screening, this setting represents an important opportunity to exert a large public health impact on cessation among smokers who are at very high risk for multiple tobacco-related diseases. If this evidence-based, brief, and scalable intervention is replicated, TC could help to improve the overall cost-effectiveness of LCS. NCT02267096, https://clinicaltrials.gov.

Taylor KL ，Hagerman CJ ，Luta G ，Bellini PG ，Stanton C ，Abrams DB ，Kramer JA ，Anderson E ，Regis S ，McKee A ，McKee B ，Niaura R ，Harper H ，Ramsaier M ... -  《-》

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》

A Randomized Trial of Telephone-Based Smoking Cessation Treatment in the Lung Cancer Screening Setting.

Lung cancer mortality is reduced via low-dose computed tomography screening and treatment of early-stage disease. Evidence-based smoking cessation treatment in the lung screening setting can further reduce mortality. We report the results of a cessation trial from the National Cancer Institute's Smoking Cessation at Lung Examination collaboration. Eligible patients (n = 818) aged 50-80 years were randomly assigned (May 2017-January 2021) to the intensive vs minimal arms (8 vs 3 phone sessions plus 8 vs 2 weeks of nicotine patches, respectively). Bio-verified (primary) and self-reported 7-day abstinence rates were assessed at 3, 6, and 12 months post random assignment. Logistic regression analyses evaluated the effects of study arm. All statistical tests were 2-sided. Participants reported 48.0 (SD = 17.2) pack-years, and 51.6% were not ready to quit in less than 30 days. Self-reported 3-month quit rates were statistically significantly higher in the intensive vs minimal arm (14.3% vs 7.9%; odds ratio [OR] = 2.00, 95% confidence interval [CI] = 1.26 to 3.18). Bio-verified abstinence was lower but with similar relative differences between arms (9.1% vs 3.9%; OR = 2.70, 95% CI = 1.44 to 5.08). Compared with the minimal arm, the intensive arm was more effective among those with greater nicotine dependence (OR = 3.47, 95% CI = 1.55 to 7.76), normal screening results (OR = 2.58, 95% CI = 1.32 to 5.03), high engagement in counseling (OR = 3.03, 95% CI = 1.50 to 6.14), and patch use (OR = 2.81, 95% CI = 1.39 to 5.68). Abstinence rates did not differ statistically significantly between arms at 6 months (OR = 1.2, 95% CI = 0.68 to 2.11) or 12 months (OR = 1.4, 95% CI = 0.82 to 2.42). Delivering intensive telephone counseling and nicotine replacement with lung screening is an effective strategy to increase short-term smoking cessation. Methods to maintain short-term effects are needed. Even with modest quit rates, integrating cessation treatment into lung screening programs may have a large impact on tobacco-related mortality.

Taylor KL ，Williams RM ，Li T ，Luta G ，Smith L ，Davis KM ，Stanton CA ，Niaura R ，Abrams D ，Lobo T ，Mandelblatt J ，Jayasekera J ，Meza R ，Jeon J ，Cao P ，Anderson ED ，Georgetown Lung Screening, Tobacco, and Health Trial ... -  《-》