The Optimizing Lung Screening Trial (WF-20817CD)

Abstract

BackgroundOne-half of all people who undergo lung cancer screening (LCS) currently use tobacco. However, few published studies have explored how to implement effective tobacco use treatment optimally during the LCS encounter.Research QuestionWas the Optimizing Lung Screening intervention (OaSiS) effective at reducing tobacco use among patients undergoing LCS in community-based radiology facilities?Study Design and MethodsThe OaSiS study (National Cancer Institute [NCI] Protocol No.: WF-20817CD) is an effectiveness-implementation hybrid type II cluster randomized trial of radiology facilities conducted in partnership with the Wake Forest National Cancer Institute Community Oncology Research Program research base. We randomly assigned 26 radiology facilities in 20 states to the intervention or usual care group. Staff at intervention facilities implemented a variety of strategies targeting the clinic and care team. Eligible patient participants were aged 55 to 77 years undergoing LCS and currently using tobacco. Of 1,094 who completed a baseline survey (523 intervention group, 471 control group) immediately before the LCS appointment, 956 completed the 6-month follow-up (86% retention rate). Fifty-four percent of those who reported not using tobacco at 6 months completed biochemical verification via mailed cotinine assay. Generalized estimating equation marginal models were used in an intention-to-treat analysis to predict 7-day tobacco use abstinence.ResultsThe average self-reported abstinence among participants varied considerably across facilities (0%-27%). Despite a significant increase in average cessation rate over time (0% at baseline to approximately 13% at 6 months; P < .0001), tobacco use did not differ by trial group at 14 days (OR, 0.96; 95% CI, 0.46-1.99; P = .90), 3 months (OR, 1.17; 95% CI, 0.69-1.99; P = .56), or 6 months (OR, 0.97; 95% CI, 0.65-1.43; P = .87).InterpretationThe OaSiS trial participants showed a significant reduction in tobacco use over time, but no difference by trial arm was found.Trial RegistryClinicalTrials.gov; No.: NCT03291587; URL: www.clinicaltrials.gov One-half of all people who undergo lung cancer screening (LCS) currently use tobacco. However, few published studies have explored how to implement effective tobacco use treatment optimally during the LCS encounter. Was the Optimizing Lung Screening intervention (OaSiS) effective at reducing tobacco use among patients undergoing LCS in community-based radiology facilities? The OaSiS study (National Cancer Institute [NCI] Protocol No.: WF-20817CD) is an effectiveness-implementation hybrid type II cluster randomized trial of radiology facilities conducted in partnership with the Wake Forest National Cancer Institute Community Oncology Research Program research base. We randomly assigned 26 radiology facilities in 20 states to the intervention or usual care group. Staff at intervention facilities implemented a variety of strategies targeting the clinic and care team. Eligible patient participants were aged 55 to 77 years undergoing LCS and currently using tobacco. Of 1,094 who completed a baseline survey (523 intervention group, 471 control group) immediately before the LCS appointment, 956 completed the 6-month follow-up (86% retention rate). Fifty-four percent of those who reported not using tobacco at 6 months completed biochemical verification via mailed cotinine assay. Generalized estimating equation marginal models were used in an intention-to-treat analysis to predict 7-day tobacco use abstinence. The average self-reported abstinence among participants varied considerably across facilities (0%-27%). Despite a significant increase in average cessation rate over time (0% at baseline to approximately 13% at 6 months; P < .0001), tobacco use did not differ by trial group at 14 days (OR, 0.96; 95% CI, 0.46-1.99; P = .90), 3 months (OR, 1.17; 95% CI, 0.69-1.99; P = .56), or 6 months (OR, 0.97; 95% CI, 0.65-1.43; P = .87). The OaSiS trial participants showed a significant reduction in tobacco use over time, but no difference by trial arm was found. ClinicalTrials.gov; No.: NCT03291587; URL: www.clinicaltrials.gov FOR EDITORIAL COMMENT, SEE PAGE 292Take-home PointsStudy Question: Are radiology facilities able to promote tobacco use cessation effectively among individuals who undergo lung cancer screening using provider- and systems-level implementation of tobacco use treatment?Results: Thirteen percent of participants who smoke in the Optimizing Lung Screening Trial quit using tobacco at 6 months after implementation (P < .0001), but tobacco use did not differ by trial group at 14 days, 3 months, or 6 months.Interpretation: Radiology facilities varied widely in their adoption and sustainability of evidence-based tobacco use treatment, and this heterogeneity may have influenced site-level variation in quit rates among patients undergoing lung cancer screening. FOR EDITORIAL COMMENT, SEE PAGE 292 Study Question: Are radiology facilities able to promote tobacco use cessation effectively among individuals who undergo lung cancer screening using provider- and systems-level implementation of tobacco use treatment? Results: Thirteen percent of participants who smoke in the Optimizing Lung Screening Trial quit using tobacco at 6 months after implementation (P < .0001), but tobacco use did not differ by trial group at 14 days, 3 months, or 6 months. Interpretation: Radiology facilities varied widely in their adoption and sustainability of evidence-based tobacco use treatment, and this heterogeneity may have influenced site-level variation in quit rates among patients undergoing lung cancer screening. Lung cancer accounts for almost 25% of cancer deaths in the United States.1American Cancer SocietyKey statistics for lung cancer: how common is lung cancer? American Cancer Society website.https://www.cancer.org/cancer/lung-cancer/about/key-statistics.htmlGoogle Scholar In 2011, the US National Lung Screening Trial (NLST) demonstrated that annual low-dose CT imaging reduced lung cancer mortality by 20% compared with chest radiography.2Aberle D.R. Adams A.M. Berg C.D. et al.Reduced lung-cancer mortality with low-dose computed tomographic screening.N Engl J Med. 2011; 365: 395-409Crossref PubMed Scopus (7397) Google Scholar Lung cancer screening (LCS) has the greatest public health benefit when coupled with tobacco use cessation.3Tanner N.T. Kanodra N.M. Gebregziabher M. et al.The association between smoking abstinence and mortality in the National Lung Screening Trial.Am J Respir Crit Care Med. 2016; 193: 534-541Crossref PubMed Scopus (140) Google Scholar,4Meza R. Cao P. Jeon J. et al.Impact of joint lung cancer screening and cessation interventions under the new recommendations of the US Preventive Services Task Force.J Thorac Oncol. 2022; 17: 160-166Abstract Full Text Full Text PDF PubMed Scopus (12) Google Scholar Offering moderately effective tobacco use treatments (TUTs) at the time patients who use tobacco undergo LCS could lead to 13% of individuals quitting,5Evans W.K. Gauvreau C.L. Flanagan W.M. et al.Clinical impact and cost-effectiveness of integrating smoking cessation into lung cancer screening: a microsimulation model.CMAJ Open. 2020; 8: e585-e592Crossref PubMed Scopus (18) Google Scholar with an additional 1.2% reduction in lung cancer incidence and more life-years saved vs screening alone.6Cadham C.J. Cao P. Jayasekera J. et al.Cost-effectiveness of smoking cessation interventions in the lung cancer screening setting: a simulation study.J Natl Cancer Inst. 2021; 113: 1065-1073Crossref PubMed Scopus (31) Google Scholar Meza et al4Meza R. Cao P. Jeon J. et al.Impact of joint lung cancer screening and cessation interventions under the new recommendations of the US Preventive Services Task Force.J Thorac Oncol. 2022; 17: 160-166Abstract Full Text Full Text PDF PubMed Scopus (12) Google Scholar further demonstrated that TUT with low-dose CT screening substantially reduces lung cancer deaths and increases life-years. For example, adding a cessation intervention of modest effectiveness (15%) to low-dose CT screening results in life-year gains that are comparable with increasing screening uptake from 30% to 100%. In 2015, the Centers for Medicare and Medicaid Services (CMS) required that all patients who use tobacco and undergo LCS receive information on the importance of tobacco use cessation and TUT.7Tammemägi M.C. Berg C.D. Riley T.L. Cunningham C.R. Taylor K.L. Impact of lung cancer screening results on smoking cessation.J Natl Cancer Inst. 2014; 106: dju084Crossref PubMed Scopus (158) Google Scholar CMS also advised that TUT be offered at a shared decision-making visit to discuss screening and at the time of screening. In 2022, CMS removed the requirement that radiology facilities make tobacco use cessation interventions available to those who use tobacco. Nonetheless, LCS serves as an excellent opportunity to expand reach of TUT, given that one-half of all those who undergo LCS currently use tobacco. Few published studies have explored how to optimize the implementation and effectiveness of cessation support during the LCS encounter. The Optimizing Lung Screening Intervention (OaSiS) Trial is a cluster randomized trial to reduce tobacco use among participants undergoing LCS at community-based radiology facilities affiliated with the National Cancer Institute Community Oncology Research Program (NCORP).8Foley K.L. Miller Jr., D.P. Weaver K. et al.The OaSiS trial: a hybrid type II, national cluster randomized trial to implement smoking cessation during CT screening for lung cancer.Contemp Clin Trials. 2020; 91105963Crossref PubMed Scopus (8) Google Scholar This trial is part of the Smoking Cessation at Lung Examination Collaboration.9Joseph A.M. Rothman A.J. Almirall D. et al.Lung cancer screening and smoking cessation clinical trials. SCALE (Smoking Cessation within the Context of Lung Cancer Screening) Collaboration.Am J Respir Crit Care Med. 2018; 197: 172-182Crossref PubMed Scopus (90) Google Scholar,10National Cancer InstituteSmoking cessation at lung examination: the SCALE Collaboration. National Cancer Institute website.https://cancercontrol.cancer.gov/brp/tcrb/scale-collaborationGoogle Scholar The Smoking Cessation at Lung Examination Collaboration is an effort combining eight federally funded research studies targeting how best to support tobacco use treatment for patients undergoing LCS. The OaSiS study (Identifier: WF-20817CD) is an effectiveness-implementation hybrid (type II) cluster randomized trial of radiology facilities conducted in partnership with the Wake Forest NCORP Research Base.8Foley K.L. Miller Jr., D.P. Weaver K. et al.The OaSiS trial: a hybrid type II, national cluster randomized trial to implement smoking cessation during CT screening for lung cancer.Contemp Clin Trials. 2020; 91105963Crossref PubMed Scopus (8) Google Scholar A hybrid type II design was chosen because it places equal value on examining effectiveness and implementation outcomes in a single trial. Given that TUT is an evidence-based strategy that has not yet been tested rigorously and repeatedly in the LCS environment, this design gave the opportunity to it in a new and under M. hybrid combining of clinical effectiveness and implementation research to public health PubMed Scopus Google Scholar We all NCORP and cancer care research an for the trial and their NCORP with radiology facilities completed a survey that LCS the and of LCS and of tobacco cessation support within the radiology Cancer care research information from the of the radiology and from health and from the health to the be in the radiology to an LCS of at within the 6 months, to be to be and to be able to a who as the study and to promote tobacco use Radiology facilities were not from on cessation support A health with more radiology to in this trial. 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