Comparing Smoking Cessation Interventions among Underserved Patients Referred for Lung Cancer Screening: A Pragmatic Trial Protocol

Rachel Kohn, Anil Vachani, Dylan Small, Alisa J Stephens-Shields, Dorothy Sheu, Vanessa L Madden, Brian A Bayes, Marzana Chowdhury, Sadie Friday, Jannie Kim, Michael K Gould, Mohamed H Ismail, Beth Creekmur, Matthew A Facktor, Charlotte Collins, Kristina K Blessing, Christine M Neslund-Dudas, Michael J Simoff, Elizabeth R Alleman, Leonard H Epstein, Michael A Horst, Michael E Scott, Kevin G Volpp, Scott D Halpern, Joanna L Hart, Stakeholder Advisory Committee, Andrea Ferris, George Fernandez, Amanda Holm, Sarah Evers-Casey, Benjamin Broder, Curt Hammock, Karen Yacobucci, M Regina Clanton, Ryan Coffman, Rachel Kohn, Anil Vachani, Dylan Small, Alisa J Stephens-Shields, Dorothy Sheu, Vanessa L Madden, Brian A Bayes, Marzana Chowdhury, Sadie Friday, Jannie Kim, Michael K Gould, Mohamed H Ismail, Beth Creekmur, Matthew A Facktor, Charlotte Collins, Kristina K Blessing, Christine M Neslund-Dudas, Michael J Simoff, Elizabeth R Alleman, Leonard H Epstein, Michael A Horst, Michael E Scott, Kevin G Volpp, Scott D Halpern, Joanna L Hart, Stakeholder Advisory Committee, Andrea Ferris, George Fernandez, Amanda Holm, Sarah Evers-Casey, Benjamin Broder, Curt Hammock, Karen Yacobucci, M Regina Clanton, Ryan Coffman

Abstract

Smoking burdens are greatest among underserved patients. Lung cancer screening (LCS) reduces mortality among individuals at risk for smoking-associated lung cancer. Although LCS programs must offer smoking cessation support, the interventions that best promote cessation among underserved patients in this setting are unknown. This stakeholder-engaged, pragmatic randomized clinical trial will compare the effectiveness of four interventions promoting smoking cessation among underserved patients referred for LCS. By using an additive study design, all four arms provide standard "ask-advise-refer" care. Arm 2 adds free or subsidized pharmacologic cessation aids, arm 3 adds financial incentives up to $600 for cessation, and arm 4 adds a mobile device-delivered episodic future thinking tool to promote attention to long-term health goals. We hypothesize that smoking abstinence rates will be higher with the addition of each intervention when compared with arm 1. We will enroll 3,200 adults with LCS orders at four U.S. health systems. Eligible patients include those who smoke at least one cigarette daily and self-identify as a member of an underserved group (i.e., is Black or Latinx, is a rural resident, completed a high school education or less, and/or has a household income <200% of the federal poverty line). The primary outcome is biochemically confirmed smoking abstinence sustained through 6 months. Secondary outcomes include abstinence sustained through 12 months, other smoking-related clinical outcomes, and patient-reported outcomes. This pragmatic randomized clinical trial will identify the most effective smoking cessation strategies that LCS programs can implement to reduce smoking burdens affecting underserved populations. Clinical trial registered with clinicaltrials.gov (NCT04798664). Date of registration: March 12, 2021. Date of trial launch: May 17, 2021.

Keywords: lung cancer screening; pragmatic clinical trial; smoking cessation; tobacco cessation; vulnerable populations.

Figures

Figure 1.
Figure 1.
Conceptual model.
Figure 2.
Figure 2.
Pragmatism of the proposed trial based on PRagmatic–Explanatory Continuum Indicator Summary 2 criteria (PRECIS-2) (25, 26).
Figure 3.
Figure 3.
Study schema. CT = computed tomography; LCS = lung cancer screening; PRO = patient-reported outcomes.
Figure 4.
Figure 4.
Stakeholder Advisory Committee members. COPD = chronic obstructive pulmonary disease.

References

    1. Rostron BL, Chang CM, Pechacek TF. Estimation of cigarette smoking-attributable morbidity in the United States. JAMA Intern Med . 2014;174:1922–1928.
    1. Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, et al. National Lung Screening Trial Research Team Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med . 2011;365:395–409.
    1. Moyer VA, U.S. Preventive Services Task Force Screening for lung cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med . 2014;160:330–338.
    1. Kathuria H, Detterbeck FC, Fathi JT, Fennig K, Gould MK, Jolicoeur DG, et al. Stakeholder research priorities for smoking cessation interventions within lung cancer screening programs: an official American Thoracic Society research statement. Am J Respir Crit Care Med . 2017;196:1202–1212.
    1. Krist AH, Davidson KW, Mangione CM, Barry MJ, Cabana M, Caughey AB, et al. U.S. Preventive Services Task Force Screening for lung cancer: US Preventive Services Task Force recommendation statement. JAMA . 2021;325:962–970.
    1. Humphrey LL, Deffebach M, Pappas M, Baumann C, Artis K, Mitchell JP, et al. Screening for lung cancer with low-dose computed tomography: a systematic review to update the US Preventive Services Task Force recommendation. Ann Intern Med . 2013;159:411–420.
    1. Ma J, Ward EM, Smith R, Jemal A. Annual number of lung cancer deaths potentially avertable by screening in the United States. Cancer . 2013;119:1381–1385.
    1. Steliga MA, Yang P. Integration of smoking cessation and lung cancer screening. Transl Lung Cancer Res . 2019;8:S88–S94.
    1. Tammemägi MC, Berg CD, Riley TL, Cunningham CR, Taylor KL. Impact of lung cancer screening results on smoking cessation. J Natl Cancer Inst . 2014;106:dju084.
    1. Tanner NT, Kanodra NM, Gebregziabher M, Payne E, Halbert CH, Warren GW, et al. The association between smoking abstinence and mortality in the National Lung Screening Trial. Am J Respir Crit Care Med . 2016;193:534–541.
    1. Fucito LM, Czabafy S, Hendricks PS, Kotsen C, Richardson D, Toll BA, Association for the Treatment of Tobacco Use and Dependence/Society for Research on Nicotine and Tobacco Synergy Committee Pairing smoking-cessation services with lung cancer screening: a clinical guideline from the Association for the Treatment of Tobacco Use and Dependence and the Society for Research on Nicotine and Tobacco. Cancer . 2016;122:1150–1159.
    1. Wiener RS, Gould MK, Arenberg DA, Au DH, Fennig K, Lamb CR, et al. ATS/ACCP Committee on Low-Dose CT Lung Cancer Screening in Clinical Practice An official American Thoracic Society/American College of Chest Physicians policy statement: implementation of low-dose computed tomography lung cancer screening programs in clinical practice. Am J Respir Crit Care Med . 2015;192:881–891.
    1. Trinidad DR, Pérez-Stable EJ, White MM, Emery SL, Messer K. A nationwide analysis of US racial/ethnic disparities in smoking behaviors, smoking cessation, and cessation-related factors. Am J Public Health . 2011;101:699–706.
    1. Hill S, Amos A, Clifford D, Platt S. Impact of tobacco control interventions on socioeconomic inequalities in smoking: review of the evidence. Tob Control . 2014;23:e89–e97.
    1. Kaplan RC, Bangdiwala SI, Barnhart JM, Castañeda SF, Gellman MD, Lee DJ, et al. Smoking among U.S. Hispanic/Latino adults: the Hispanic community health study/study of Latinos. Am J Prev Med . 2014;46:496–506.
    1. Health equity style guide for the COVID-19 response: principles and preferred terms for non-stigmatizing, bias-free language Atlanta, GA: Centers for Disease Control and Prevention; 2020. [updated 2020 Aug 11; accessed 2021 Apr 5]. Available from:
    1. Bailey SR, Heintzman J, Jacob RL, Puro J, Marino M. Disparities in smoking cessation assistance in US primary care clinics. Am J Public Health . 2018;108:1082–1090.
    1. Vijayaraghavan M, Benmarhnia T, Pierce JP, White MM, Kempster J, Shi Y, et al. Income disparities in smoking cessation and the diffusion of smoke-free homes among U.S. smokers: results from two longitudinal surveys. PLoS One . 2018;13:e0201467.
    1. Kulak JA, Cornelius ME, Fong GT, Giovino GA. Differences in quit attempts and cigarette smoking abstinence between Whites and African Americans in the United States: literature review and results from the International Tobacco Control US Survey. Nicotine Tob Res . 2016;18:S79–S87.
    1. Taylor KL, Cox LS, Zincke N, Mehta L, McGuire C, Gelmann E. Lung cancer screening as a teachable moment for smoking cessation. Lung Cancer . 2007;56:125–134.
    1. Reid JL, Hammond D, Boudreau C, Fong GT, Siahpush M, ITC Collaboration Socioeconomic disparities in quit intentions, quit attempts, and smoking abstinence among smokers in four Western countries: findings from the International Tobacco Control Four Country Survey. Nicotine Tob Res . 2010;12:S20–S33.
    1. Joseph AM, Rothman AJ, Almirall D, Begnaud A, Chiles C, Cinciripini PM, 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;197:172–182.
    1. Slatore CG, Baumann C, Pappas M, Humphrey LL. Smoking behaviors among patients receiving computed tomography for lung cancer screening: systematic review in support of the U.S. Preventive Services Task Force. Ann Am Thorac Soc . 2014;11:619–627.
    1. Brain K, Carter B, Lifford KJ, Burke O, Devaraj A, Baldwin DR, et al. Impact of low-dose CT screening on smoking cessation among high-risk participants in the UK Lung Cancer Screening Trial. Thorax . 2017;72:912–918.
    1. Loudon K, Zwarenstein M, Sullivan F, Donnan P, Treweek S. Making clinical trials more relevant: improving and validating the PRECIS tool for matching trial design decisions to trial purpose. Trials . 2013;14:115.
    1. Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG, et al. A Pragmatic-Explanatory Continuum Indicator Summary (PRECIS): a tool to help trial designers. J Clin Epidemiol. 2009;62:464–475.
    1. Overview of the United States Minneapolis, MN: Cedar Lake Ventures; 2018. [updated 2018 Sep 4; accessed 2021 Jun 30]. Available from:
    1. Halpern SD, French B, Small DS, Saulsgiver K, Harhay MO, Audrain-McGovern J, et al. Randomized trial of four financial-incentive programs for smoking cessation. N Engl J Med. 2015;372:2108–2117.
    1. Halpern SD, Harhay MO, Saulsgiver K, Brophy C, Troxel AB, Volpp KG. A pragmatic trial of e-cigarettes, incentives, and drugs for smoking cessation. N Engl J Med . 2018;378:2302–2310.
    1. Jamal A, King BA, Neff LJ, Whitmill J, Babb SD, Graffunder CM. Current cigarette smoking among adults: United States, 2005-2015. MMWR Morb Mortal Wkly Rep . 2016;65:1205–1211.
    1. Meza R, Jeon J, Toumazis I, ten Haaf K, Cao P, Bastani M, et al. Cancer Intervention and Surveillance Modeling Network (CISNET) Lung Cancer Working Group Evaluation of the benefits and harms of lung cancer screening with low-dose computed tomography: a collaborative modeling study for the US Preventive Services Task Force. Rockville, MD: Agency for Healthcare Research and Quality; 2020. AHRQ Publication No. 20-05266-EF-2.
    1. Schroeder SA. What to do with a patient who smokes. JAMA . 2005;294:482–487.
    1. Coe JW, Brooks PR, Vetelino MG, Wirtz MC, Arnold EP, Huang J, et al. Varenicline: an α4β2 nicotinic receptor partial agonist for smoking cessation. J Med Chem . 2005;48:3474–3477.
    1. Henningfield JE, Fant RV, Buchhalter AR, Stitzer ML. Pharmacotherapy for nicotine dependence. CA Cancer J Clin . 2005;55:281–299; quiz 322–323, 325.
    1. Wilkes S. The use of bupropion SR in cigarette smoking cessation. Int J Chron Obstruct Pulmon Dis . 2008;3:45–53.
    1. Leone FT, Zhang Y, Evers-Casey S, Evins AE, Eakin MN, Fathi J, et al. Initiating pharmacologic treatment in tobacco-dependent adults: an official American Thoracic Society clinical practice guideline. Am J Respir Crit Care Med . 2020;202:e5–e31.
    1. Koh HK, Sebelius KG. Promoting prevention through the Affordable Care Act. N Engl J Med . 2010;363:1296–1299.
    1. Ku L, Bruen BK, Steinmetz E, Bysshe T. Medicaid tobacco cessation: big gaps remain in efforts to get smokers to quit. Health Aff (Millwood) . 2016;35:62–70.
    1. Sheffer CE, Anders M, Brackman SL, Steinberg MB, Barone C. Tobacco intervention practices of primary care physicians treating lower socioeconomic status patients. Am J Med Sci . 2012;343:388–396.
    1. Russell LB, Volpp KG, Kwong PL, Cosgriff BS, Harhay MO, Zhu J, et al. Cost-Effectiveness of Four Financial-Incentive Programs for Smoking Cessation. Ann Am Thorac Soc . 2021;18:1997–2006.
    1. Higgins ST, Bickel WK, Hughes JR. Influence of an alternative reinforcer on human cocaine self-administration. Life Sci. 1994;55:179–187.
    1. Silverman K, Chutuape MA, Bigelow GE, Stitzer ML. Voucher-based reinforcement of cocaine abstinence in treatment-resistant methadone patients: effects of reinforcement magnitude. Psychopharmacology (Berl) . 1999;146:128–138.
    1. Audrain-McGovern J, Rodriguez D, Epstein LH, Cuevas J, Rodgers K, Wileyto EP. Does delay discounting play an etiological role in smoking or is it a consequence of smoking? Drug Alcohol Depend . 2009;103:99–106.
    1. Hart JL, Pflug E, Madden V, Halpern SD. Thinking forward: future-oriented thinking among patients with tobacco-associated thoracic diseases and their surrogates. Am J Respir Crit Care Med . 2016;193:321–329.
    1. Bickel WK, Odum AL, Madden GJ. Impulsivity and cigarette smoking: delay discounting in current, never, and ex-smokers. Psychopharmacology (Berl) . 1999;146:447–454.
    1. Gilbert DT, Wilson TD. Prospection: experiencing the future. Science . 2007;317:1351–1354.
    1. Zeliadt SB, Heffner JL, Sayre G, Klein DE, Simons C, Williams J, et al. Attitudes and perceptions about smoking cessation in the context of lung cancer screening. JAMA Intern Med . 2015;175:1530–1537.
    1. Lin H, Epstein LH. Living in the moment: effects of time perspective and emotional valence of episodic thinking on delay discounting. Behav Neurosci . 2014;128:12–19.
    1. Athamneh LN, Stein MD, Lin EH, Stein JS, Mellis AM, Gatchalian KM, et al. Setting a goal could help you control: comparing the effect of health goal versus general episodic future thinking on health behaviors among cigarette smokers and obese individuals. Exp Clin Psychopharmacol . 2021;29:59–72.
    1. Stein JS, Tegge AN, Turner JK, Bickel WK. Episodic future thinking reduces delay discounting and cigarette demand: an investigation of the good-subject effect. J Behav Med . 2018;41:269–276.
    1. Patel H, Amlung M. Acute and extended exposure to episodic future thinking in a treatment seeking addiction sample: a pilot study. J Subst Abuse Treat . 2020;116:108046.
    1. O’Donnell S, Daniel TO, Koroschetz J, Kilanowski C, Otminski A, Bickel WK, et al. Do process simulations during episodic future thinking enhance the reduction of delay discounting for middle income participants and those living in poverty? J Behav Decis Making . 2019;32:231–240.
    1. Asch DA, Ziolek TA, Mehta SJ. Misdirections in informed consent: impediments to health care innovation. N Engl J Med. 2017;377:1412–1414.
    1. Faden RR, Kass NE, Goodman SN, Pronovost P, Tunis S, Beauchamp TL. An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics. Hastings Cent Rep . 2013;43:S16–S27.
    1. Gould MK, Smith-Bindman R, Kelly K, Altman DE, Barjaktarevic I, Creekmur B, et al. Methods for the Watch the Spot Trial: a pragmatic trial of more- versus less-intensive strategies for active surveillance of small pulmonary nodules. Ann Am Thorac Soc . 2019;16:1567–1576.
    1. Courtright KR, Halpern SD, Joffe S, Ellenberg SS, Karlawish J, Madden V, et al. Willingness to participate in pragmatic dialysis trials: the importance of physician decisional autonomy and consent approach. Trials . 2017;18:474.
    1. Kraybill A, Dember LM, Joffe S, Karlawish J, Ellenberg SS, Madden V, et al. Patient and physician views about protocolized dialysis treatment in randomized trials and clinical care. AJOB Empir Bioeth. 2016;7:106–115.
    1. Wendler D. What should be disclosed to research participants? Am J Bioeth . 2013;13:3–8.
    1. West R, Hajek P, Stead L, Stapleton J. Outcome criteria in smoking cessation trials: proposal for a common standard. Addiction . 2005;100:299–303.
    1. Hughes JR, Keely JP, Niaura RS, Ossip-Klein DJ, Richmond RL, Swan GE. Measures of abstinence in clinical trials: issues and recommendations. Nicotine Tob Res . 2003;5:13–25.
    1. Biener L, Abrams DB. The contemplation ladder: validation of a measure of readiness to consider smoking cessation. Health Psychol . 1991;10:360–365.
    1. Lee S, Cappella JN, Lerman C, Strasser AA. Effects of smoking cues and argument strength of antismoking advertisements on former smokers’ self-efficacy, attitude, and intention to refrain from smoking. Nicotine Tob Res . 2013;15:527–533.
    1. Thomas D, Mackinnon AJ, Bonevski B, Abramson MJ, Taylor S, Poole SG, et al. Development and validation of a 21-item challenges to stopping smoking (CSS-21) scale. BMJ Open . 2016;6:e011265.
    1. Koffarnus MN, Bickel WK. A 5-trial adjusting delay discounting task: accurate discount rates in less than one minute. Exp Clin Psychopharmacol . 2014;22:222–228.
    1. Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L) Qual Life Res . 2011;20:1727–1736.
    1. Proschan MA. A multiple comparison procedure for three- and four-armed controlled clinical trials. Stat Med . 1999;18:787–798.
    1. Permutt T. Do covariates change the estimand? Stat Biopharm Res . 2020;12:45–53.
    1. Heatherton TF, Kozlowski LT, Frecker RC, Fagerström KO. The Fagerström test for nicotine dependence: a revision of the Fagerström Tolerance Questionnaire. Br J Addict . 1991;86:1119–1127.
    1. Pistelli F, Aquilini F, Falaschi F, Puliti D, Ocello C, Lopes Pegna A, et al. moking cessation in the ITALUNG Lung Cancer Screening: what does “teachable moment” mean? Nicotine Tob Res . 2020;22:1484–1491.
    1. Cai B, Small DS, Have TR. Two-stage instrumental variable methods for estimating the causal odds ratio: analysis of bias. Stat Med . 2011;30:1809–1824.
    1. Newhouse JP, McClellan M. Econometrics in outcomes research: the use of instrumental variables. Annu Rev Public Health . 1998;19:17–34.
    1. Angrist JD, Imbens GW, Rubin DB. Identification of causal effects using instrumental variables. J Am Stat Assoc . 1996;91:444–455.
    1. EQUATOR Network. Enhancing the quality and transparency of health research Oxford, UK: University of Oxford; 2020. [accessed 2020 Oct 23]. Available from:
    1. Largent EA, Halpern SD, Fernandez Lynch H. Waivers and alterations of research informed consent during the COVID-19 pandemic. Ann Intern Med . 2021;174:415–416.
    1. Mobile fact sheet Washington, DC: Pew Research Center; 2021. [accessed 2021 Jun 1]. Available from:
    1. Detailed languages spoken at home and ability to speak English for the population 5 years and over: 2009–2013 Suitland, MD: U.S. Census Bureau; 2015. [accessed 2021 Feb 22]. Available from:
    1. Okereke IC, Nishi S, Zhou J, Goodwin JS. Trends in lung cancer screening in the United States, 2016-2017. J Thorac Dis . 2019;11:873–881.
    1. Fava JL, Velicer WF, Prochaska JO. Applying the transtheoretical model to a representative sample of smokers. Addict Behav . 1995;20:189–203.
    1. Cappella JN, Lerman C, Romantan A, Baruh L. News about genetics and smoking: priming, family smoking history, and news story believability on inferences of genetic susceptibility to tobacco addiction. Communic Res . 2005;32:478–502.
    1. EuroQol Group. EuroQol: a new facility for the measurement of health-related quality of life. Health Policy . 1990;16:199–208.

Source: PubMed

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

3
Abonneren