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

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

doi:10.1186/s13063-022-06568-3

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

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

Global Public Health

Research output: Contribution to journal › Article › peer-review

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: ClinicalTrials.govNCT03315910

Original language	English (US)
Article number	664
Journal	Trials
Volume	23
Issue number	1
DOIs	https://doi.org/10.1186/s13063-022-06568-3
State	Published - Dec 2022

Keywords

Implementation science
Lung cancer screening
Pragmatic clinical trial
Smoking cessation
Tobacco treatment

ASJC Scopus subject areas

Medicine (miscellaneous)
Pharmacology (medical)

Access to Document

10.1186/s13063-022-06568-3

Cite this

Ostroff, J. S., Shelley, D. R., Chichester, L. A., King, J. C., Li, Y., Schofield, E., Ciupek, A., Criswell, A., Acharya, R., Banerjee, S. C., Elkin, E. B., Lynch, K., Weiner, B. J., Orlow, I., Martin, C. M., Chan, S. V., Frederico, V., Camille, P., Holland, S., & Kenney, J. (2022). Study protocol of a multiphase optimization strategy trial (MOST) for delivery of smoking cessation treatment in lung cancer screening settings. Trials, 23(1), Article 664. https://doi.org/10.1186/s13063-022-06568-3

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 2022, 'Study protocol of a multiphase optimization strategy trial (MOST) for delivery of smoking cessation treatment in lung cancer screening settings', Trials, vol. 23, no. 1, 664. https://doi.org/10.1186/s13063-022-06568-3

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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: ClinicalTrials.govNCT03315910",

keywords = "Implementation science, Lung cancer screening, Pragmatic clinical trial, Smoking cessation, Tobacco treatment",

author = "Ostroff, {Jamie S.} and Shelley, {Donna R.} and Chichester, {Lou Anne} and King, {Jennifer C.} and Yuelin Li and Elizabeth Schofield and Andrew Ciupek and Angela Criswell and Rashmi Acharya and Banerjee, {Smita C.} and Elkin, {Elena B.} and Kathleen Lynch and Weiner, {Bryan J.} and Irene Orlow and Martin, {Chlo{\'e} M.} and Chan, {Sharon V.} and Victoria Frederico and Phillip Camille and Susan Holland and Jessica Kenney",

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year = "2022",

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doi = "10.1186/s13063-022-06568-3",

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T1 - Study protocol of a multiphase optimization strategy trial (MOST) for delivery of smoking cessation treatment in lung cancer screening settings

AU - Ostroff, Jamie S.

AU - Shelley, Donna R.

AU - Chichester, Lou Anne

AU - King, Jennifer C.

AU - Li, Yuelin

AU - Schofield, Elizabeth

AU - Ciupek, Andrew

AU - Criswell, Angela

AU - Acharya, Rashmi

AU - Banerjee, Smita C.

AU - Elkin, Elena B.

AU - Lynch, Kathleen

AU - Weiner, Bryan J.

AU - Orlow, Irene

AU - Martin, Chloé M.

AU - Chan, Sharon V.

AU - Frederico, Victoria

AU - Camille, Phillip

AU - Holland, Susan

AU - Kenney, Jessica

PY - 2022/12

Y1 - 2022/12

N2 - 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: ClinicalTrials.govNCT03315910

AB - 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: ClinicalTrials.govNCT03315910

KW - Implementation science

KW - Lung cancer screening

KW - Pragmatic clinical trial

KW - Smoking cessation

KW - Tobacco treatment

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