Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Lung Cancer | Study protocol

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

Authors: Jamie S. Ostroff, Donna R. Shelley, Lou-Anne Chichester, Jennifer C. King, Yuelin Li, Elizabeth Schofield, Andrew Ciupek, Angela Criswell, Rashmi Acharya, Smita C. Banerjee, Elena B. Elkin, Kathleen Lynch, Bryan J. Weiner, Irene Orlow, Chloé M. Martin, Sharon V. Chan, Victoria Frederico, Phillip Camille, Susan Holland, Jessica Kenney

Published in: Trials | Issue 1/2022

Login to get access

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

Footnotes
1
Columbia University, Rutgers University, University of Colorado and the University of Washington
 
Literature
1.
Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, et al. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011;365(5):395–409.PubMedCrossRef
2.
Moyer VA. Screening for lung cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014;160(5):330–8.PubMedCrossRef
3.
US Preventive Services Task Force. Screening for lung cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2021;325(10):962–70.CrossRef
4.
Henderson LM, Rivera MP, Basch E. Broadened eligibility for lung cancer screening: challenges and uncertainty for implementation and equity. JAMA. 2021;325(10):939–41.PubMedCrossRef
5.
Taylor KL, Cox LS, Zincke N, Mehta L, McGuire C, Gelmann E. Lung cancer screening as a teachable moment for smoking cessation. Lung Cancer (Amsterdam, Netherlands). 2007;56(1):125–34.CrossRef
6.
Villanti AC, Jiang Y, Abrams DB, Pyenson BS. A cost-utility analysis of lung cancer screening and the additional benefits of incorporating smoking cessation interventions. PloS One. 2013;8(8):e71379.PubMedPubMedCentralCrossRef
7.
Fucito LM, Czabafy S, Hendricks PS, Kotsen C, Richardson D, Toll BA, et al. 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(8):1150–9.PubMedCrossRef
8.
Black WC, Gareen IF, Soneji SS, Sicks JD, Keeler EB, Aberle DR, et al. Cost-effectiveness of CT screening in the National Lung Screening Trial. N Engl J Med. 2014;371(19):1793–802.PubMedPubMedCentralCrossRef
9.
McMahon PM, Kong CY, Bouzan C, Weinstein MC, Cipriano LE, Tramontano AC, et al. Cost-effectiveness of computed tomography screening for lung cancer in the United States. J Thorac Oncol. 2011;6(11):1841–8.PubMedPubMedCentralCrossRef
10.
US Department of Health and Human Services. Smoking cessation: a report of the surgeon general-executive summary. Atlanta: US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2020.
11.
Ostroff JS, Copeland A, Borderud SP, Li Y, Shelley DR, Henschke CI. Readiness of lung cancer screening sites to deliver smoking cessation treatment: current practices, organizational priority, and perceived barriers. Nicotine Tob Res. 2016;18(5):1067–75.PubMedCrossRef
12.
13.
Clark MM, Cox LS, Jett JR, Patten CA, Schroeder DR, Nirelli LM, et al. Effectiveness of smoking cessation self-help materials in a lung cancer screening population. Lung Cancer (Amsterdam, Netherlands). 2004;44(1):13–21.CrossRef
14.
Ferketich AK, Otterson GA, King M, Hall N, Browning KK, Wewers ME. A pilot test of a combined tobacco dependence treatment and lung cancer screening program. Lung Cancer (Amsterdam, Netherlands). 2012;76(2):211–5.CrossRef
15.
van der Aalst CM, de Koning HJ, van den Bergh KA, Willemsen MC, van Klaveren RJ. The effectiveness of a computer-tailored smoking cessation intervention for participants in lung cancer screening: a randomised controlled trial. Lung Cancer (Amsterdam, Netherlands). 2012;76(2):204–10.CrossRef
16.
Cadham CJ, Cao P, Jayasekera J, Taylor KL, Levy DT, Jeon J, et al. Cost-effectiveness of smoking cessation interventions in the lung cancer screening setting: a simulation study. J Natl Cancer Inst. 2021;113(8):1065–73.PubMedPubMedCentralCrossRef
17.
Woods MN, Harris KJ, Mayo MS, Catley D, Scheibmeir M, Ahluwalia JS. Participation of African Americans in a smoking cessation trial: a quantitative and qualitative study. J Natl Med Assoc. 2002;94(7):609–18.PubMedPubMedCentral
18.
Kilbourne AM, Switzer G, Hyman K, Crowley-Matoka M, Fine MJ. Advancing health disparities research within the health care system: a conceptual framework. Am J Public Health. 2006;96(12):2113–21.PubMedPubMedCentralCrossRef
19.
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(2):172–82.PubMedPubMedCentralCrossRef
20.
Collins LM, Baker TB, Mermelstein RJ, Piper ME, Jorenby DE, Smith SS, et al. The multiphase optimization strategy for engineering effective tobacco use interventions. Ann Behav Med. 2011;41(2):208–26.PubMedCrossRef
21.
Collins LM, Dziak JJ, Kugler KC, Trail JB. Factorial experiments: efficient tools for evaluation of intervention components. Am J Prev Med. 2014;47(4):498–504.PubMedPubMedCentralCrossRef
22.
Collins LM, Dziak JJ, Li R. Design of experiments with multiple independent variables: a resource management perspective on complete and reduced factorial designs. Psychol Methods. 2009;14(3):202–24.PubMedPubMedCentralCrossRef
23.
Chakraborty B, Collins LM, Strecher VJ, Murphy SA. Developing multicomponent interventions using fractional factorial designs. Stat Med. 2009;28(21):2687–708.PubMedPubMedCentralCrossRef
24.
Nair V, Strecher V, Fagerlin A, Ubel P, Resnicow K, Murphy S, et al. Screening experiments and the use of fractional factorial designs in behavioral intervention research. Am J Public Health. 2008;98(8):1354–9.PubMedPubMedCentralCrossRef
25.
Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, et al. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011;38(2):65–76.PubMedCrossRef
26.
Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. IS. 2009;4:50.PubMedPubMedCentral
27.
Humphrey L, Deffebach M, Pappas M, Baumann C, Artis K, Mitchell JP, et al. U.S. Preventive Services Task Force Evidence Syntheses, formerly Systematic Evidence Reviews. Screening for lung cancer: systematic review to update the US Preventive Services Task Force Recommendation. Rockville: Agency for Healthcare Research and Quality (US); 2013.
28.
29.
Heckman CJ, Egleston BL, Hofmann MT. Efficacy of motivational interviewing for smoking cessation: a systematic review and meta-analysis. Tob Control. 2010;19(5):410–6.PubMedCrossRef
30.
Lindson N, Thompson TP, Ferrey A, Lambert JD, Aveyard P. Motivational interviewing for smoking cessation. Cochrane Database Syst Rev. 2019;7(7):Cd006936.PubMed
31.
Stead LF, Perera R, Bullen C, Mant D, Lancaster T. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2008;1:Cd000146.
32.
Hughes JR, Solomon LJ, Livingston AE, Callas PW, Peters EN. A randomized, controlled trial of NRT-aided gradual vs. abrupt cessation in smokers actively trying to quit. Drug Alcohol Depend. 2010;111(1-2):105–13.PubMedPubMedCentralCrossRef
33.
Toll BA, Rojewski AM, Duncan LR, Latimer-Cheung AE, Fucito LM, Boyer JL, et al. “Quitting smoking will benefit your health”: the evolution of clinician messaging to encourage tobacco cessation. Clin Cancer Res. 2014;20(2):301–9.PubMedPubMedCentralCrossRef
34.
Latimer-Cheung AE, Fucito LM, Carlin-Menter S, Rodriguez J, Raymond L, Salovey P, et al. How do perceptions about cessation outcomes moderate the effectiveness of a gain-framed smoking cessation telephone counseling intervention? J Health Commun. 2012;17(9):1081–98.PubMedPubMedCentralCrossRef
35.
Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory M, et al. Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium. Health Psychol. 2004;23(5):443–51.PubMedCrossRef
36.
Duffy SA, Cummins SE, Fellows JL, Harrington KF, Kirby C, Rogers E, et al. Fidelity monitoring across the seven studies in the Consortium of Hospitals Advancing Research on Tobacco (CHART). Tob Induc Dis. 2015;13(1):29.PubMedPubMedCentralCrossRef
37.
Moyers TB, Rowell LN, Manuel JK, Ernst D, Houck JM. The motivational interviewing treatment integrity code (MITI 4): Rationale, preliminary reliability and validity. J Subst Abuse Treat. 2016;65:36–42.PubMedPubMedCentralCrossRef
38.
Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam Med. 2004;36(8):588–94.PubMed
39.
40.
41.
Charlson M, Szatrowski TP, Peterson J, Gold J. Validation of a combined comorbidity index. J Clin Epidemiol. 1994;47(11):1245–51.PubMedCrossRef
42.
43.
Heatherton TF, Kozlowski LT, Frecker RC, Rickert W, Robinson J. Measuring the heaviness of smoking: Using self-reported time to the first cigarette of the day and number of cigarettes smoked per day. Addiction. 1989;84(7):791–800.CrossRef
44.
Kessler RC, Andrews G, Colpe LJ, Hiripi E, Mroczek DK, Normand SL, et al. Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychol Med. 2002;32(6):959–76.PubMedCrossRef
45.
Bush K, Kivlahan DR, McDonell MB, Fihn SD, Bradley KA. The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test. Arch Intern Med. 1998;158(16):1789–95.PubMedCrossRef
46.
47.
Park ER, Streck JM, Gareen IF, Ostroff JS, Hyland KA, Rigotti NA, et al. A qualitative study of lung cancer risk perceptions and smoking beliefs among national lung screening trial participants. Nicotine Tob Res. 2014;16(2):166–73.PubMedCrossRef
48.
Apodaca TR, Abrantes AM, Strong DR, Ramsey SE, Brown RA. Readiness to change smoking behavior in adolescents with psychiatric disorders. Addict Behav. 2007;32(6):1119–30.PubMedCrossRef
49.
Etter JF, Perneger TV. Attitudes toward nicotine replacement therapy in smokers and ex-smokers in the general public. Clin Pharmacol Ther. 2001;69(3):175–83.PubMedCrossRef
50.
Brown-Johnson CG, Cataldo JK, Orozco N, Lisha NE, Hickman NJ 3rd, Prochaska JJ. Validity and reliability of the Internalized Stigma of Smoking Inventory: an exploration of shame, isolation, and discrimination in smokers with mental health diagnoses. Am J Addict. 2015;24(5):410–8.PubMedPubMedCentralCrossRef
51.
Malone S, Prewitt K, Hackett R, Lin JC, McKay V, Walsh-Bailey C, et al. The Clinical Sustainability Assessment Tool: Measuring organizational capacity to promote sustainability in healthcare. Implement Sci Commun. 2021;2(1):77.PubMedPubMedCentralCrossRef
52.
53.
Nguyen TD, Attkisson CC, Stegner BL. Assessment of patient satisfaction: development and refinement of a service evaluation questionnaire. Eval Program Plann. 1983;6(3-4):299–313.PubMedCrossRef
54.
Avila-Tang E, Al-Delaimy WK, Ashley DL, Benowitz N, Bernert JT, Kim S, et al. Assessing secondhand smoke using biological markers. Tob Control. 2013;22(3):164–71.PubMedCrossRef
55.
Benowitz NL, Hukkanen J, Jacob P 3rd. Nicotine chemistry, metabolism, kinetics and biomarkers. Handb Exp Pharmacol. 2009;192:29–60.CrossRef
56.
Regan S, Reid ZZ, Kelley JH, Reyen M, Korotkin M, Japuntich SJ, et al. Smoking status confirmation by proxy: validation in a smoking cessation trial. Nicotine Tob Res. 2016;18(1):34–40.PubMed
57.
Biener L, Abrams DB. The Contemplation Ladder: validation of a measure of readiness to consider smoking cessation. Health Psychol. 1991;10(5):360–5.PubMedCrossRef
58.
59.
Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, et al. Psychometric assessment of three newly developed implementation outcome measures. IS. 2017;12(1):108.PubMedPubMedCentral
60.
Creswell JW. Qualitative inquiry and research design: choosing among five traditions. Thousand Oaks: SAGE; 1998.
61.
Reisinger SA, Kamel S, Seiber E, Klein EG, Paskett ED, Wewers ME. Cost-effectiveness of community-based tobacco dependence treatment interventions: initial findings of a systematic review. Prev Chronic Dis. 2019;16:E161.PubMedPubMedCentralCrossRef
62.
Nich C, Carroll KM. Intention-to-treat meets missing data: implications of alternate strategies for analyzing clinical trials data. Drug Alcohol Depend. 2002;68(2):121–30.PubMedPubMedCentralCrossRef
63.
Benjamini Y, Yekutieli D. The control of the false discovery rate in multiple testing under dependency. Ann Stat. 2001;29(4):1165–88.CrossRef
64.
Dziak JJ, Nahum-Shani I, Collins LM. Multilevel factorial experiments for developing behavioral interventions: power, sample size, and resource considerations. Psychol Methods. 2012;17(2):153–75.PubMedPubMedCentralCrossRef
65.
Cohen J. Statistical Power Analysis for the behavioral sciences. Hillsdale: L. Erlbaum Associates; 1988.
66.
Drummond MF, Sculpher MJ, Torrance GW, O’Brien BJ, Stoddart GL. Methods for the economic evaluation of health care programmes. New York: Oxford University Press; 2005.
67.
Briggs A, Gray A. The distribution of health care costs and their statistical analysis for economic evaluation. J Health Serv Res Policy. 1998;3(4):233–45.PubMedCrossRef
68.
Gold MR, Siegel JE, Russel LB, Weinstein MC. Cost-effectiveness in health and medicine. New York: Oxford University Press; 1996.
69.
70.
Bazeley BCP, Jackson K. Qualitative data analysis with NVivo (2nd ed.). Qual Res Psychol. 2015;12(4):492–4.CrossRef
71.
Stone PJ. Thematic text analysis: new agendas for analyzing text content. In: Roberts C, editor. Text analysis for the social sciences. Mahwah: Lawrence Erlbaum Associates; 1997.
72.
Morse J. Designing funded qualitative research. In: Denzin NK, Lincoln YS, editors. Handbook of qualitative research. Thousand Oaks: Sage; 1994. p. 220–35.
73.
Charmaz K. Constructing grounded theory. 2nd ed. Thousand Oaks: Sage Publications Ltd; 2014. p. 109–60.
74.
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research Electronic Data Capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81.PubMedCrossRef
75.
Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012;50(3):217–26.PubMedPubMedCentralCrossRef
76.
Waltz TJ, Powell BJ, Chinman MJ, Smith JL, Matthieu MM, Proctor EK, et al. Expert Recommendations for Implementing Change (ERIC): protocol for a mixed methods study. IS. 2014;9:39.PubMedPubMedCentral
Metadata
Title
Study protocol of a multiphase optimization strategy trial (MOST) for delivery of smoking cessation treatment in lung cancer screening settings
Authors
Jamie S. Ostroff
Donna R. Shelley
Lou-Anne Chichester
Jennifer C. King
Yuelin Li
Elizabeth Schofield
Andrew Ciupek
Angela Criswell
Rashmi Acharya
Smita C. Banerjee
Elena B. Elkin
Kathleen Lynch
Bryan J. Weiner
Irene Orlow
Chloé M. Martin
Sharon V. Chan
Victoria Frederico
Phillip Camille
Susan Holland
Jessica Kenney
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06568-3

Other articles of this Issue 1/2022

Trials 1/2022 Go to the issue

Research

Update on the clinical trial landscape: analysis of ClinicalTrials.gov registration data, 2000–2020

Research

Predictors of participants’ retention—socioeconomic factors or nonadherence: insights from a urological clinical prospective study

Study protocol

Study protocol for pragmatic trials of Internet-delivered guided and unguided cognitive behavior therapy for treating depression and anxiety in university students of two Latin American countries: the Yo Puedo Sentirme Bien study

Correction

Correction: G-CuP: the effect of a forced oral glucose intake on alcohol craving and mesolimbic cue reactivity in alcohol dependence—study protocol of a randomized, double-blind, placebo-controlled crossover study

Study protocol

Adaptive interventions to optimise the mobile phone-based smoking cessation support: study protocol for a sequential, multiple assignment, randomised trial (SMART)

Study protocol

Analgesic efficacy and safety of nalbuphine versus morphine for perioperative tumor ablation: a randomized, controlled, multicenter trial