- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03200236
The Lung Screening, Tobacco and Health Project
Integrating Evidence-Based Smoking Cessation Interventions Into Lung Cancer Screening Programs: A Randomized Trial
Study Overview
Status
Detailed Description
The investigators have built on the evidence-base of telephone counseling for smoking cessation. This pragmatic approach is designed at the intersection of scalability and intensity, for future implementation within the national tobacco quitline. In collaboration with five geographically and ethnically diverse lung cancer screening programs, the investigators will accrue smokers who have registered for screening,and are at all levels of readiness to quit. Prior to the screening day, the investigators will conduct the baseline (T0) phone interview. Following participants' receipt of their screening result (one week post-screening), the investigators will complete the T1 phone interview, provide brief advice to quit and conduct randomization. Participants will be randomized into one of two groups: ITC, in which participants are provided up to 8 counseling sessions lasting approximately 20 minutes each and access to 8-weeks of free nicotine patches. ITC will include a discussion of screening results throughout counseling sessions. The UC arm will include up to 3 counseling sessions lasting approximately 20 minutes each and access to 2-weeks of free nicotine patches. UC will not include a discussion of screening results throughout counseling sessions. All sessions will be conducted by a Tobacco Treatment Specialist (English or Spanish) and the investigators will assess intervention fidelity. In both groups, the investigators will engage referring physicians by notifying them of their patients' study enrollment and of their patients' smoking status at the 6-month follow-up. The 3-month (T2), 6-month (T3), and 12-month (T4) assessments will assess readiness to quit, quit attempts, 7-day and 30-day abstinence verified by Nicalert or carbon monoxide testing, and intervention process variables. Furthermore, two important aspects of this approach include a cost-effectiveness analysis and use of the Cancer Intervention and Surveillance Modeling Network (CISNET) to evaluate the cost of the interventions relative to their impact on short- and long-term smoking-related outcomes.
The aims are:
- To compare ITC vs. UC standard telephone counseling. H1.1. At 3-, 6-, and 12- months, the ITC arm will have significantly improved biochemically verified 7-day and 30-day abstinence, compared to UC. H1.2. Mediators, including teachable moment factors (e.g., perceived risk based on screening results) and process measures (TC and nicotine patch adherence, primary care appointment) will positively affect cessation outcomes at 3-, 6- and 12-months. H.1.3. Moderators include screening result, readiness to quit, and nicotine dependence.
- To evaluate reach (% of current smokers enrolled) and engagement (% who receive the interventions), both overall and among subgroups (gender, age, nicotine dependence, site). The investigators will assess intervention fidelity and feasibility for implementation, from both community-based and academically-based screening centers.
- To conduct an economic analysis to test the hypothesis that while costlier, ITC will be more effective and have greater reach than UC in the lung screening setting, making it more cost-effective in terms of costs per 3-, 6- and 12-month cessation rates and quit attempts. The investigators will use these results as inputs to the CISNET model to project the long-term impact of the interventions on costs per life year saved and quality-adjusted life years saved, lung cancer deaths averted, lung cancer mortality reduction, and overall population mortality.
This study's strengths include the assessment of effective cessation methods designed for widespread implementation, novel components based on unique features of screening, cost-effectiveness analyses, and leveraging the University of Michigan CISNET model to project the population impact of implementing an effective cessation intervention in lung screening programs. The overall goal is to have a substantial public health impact by providing critical data to address scalability efforts by screening centers, insurers, and policy-makers.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20007
- Georgetown University Medical Center
-
-
Florida
-
Miami, Florida, United States, 33176
- Baptist Health South Florida
-
-
Illinois
-
Moline, Illinois, United States, 61265
- UnityPoint Health --Trinity Medical Center
-
-
Maryland
-
Annapolis, Maryland, United States, 21401
- Anne Arundel Medical Center
-
Hollywood, Maryland, United States, 20636
- MedStar Shah Medical Group
-
-
Massachusetts
-
Burlington, Massachusetts, United States, 01805
- Lahey Hospital and Medical Center
-
-
New Jersey
-
Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Have a >20-pack year smoking history (i.e., smoked at least a pack a day for 20 years)
- Current smokers, regardless of number smoked per day
- Can be smoking cigarettes, cigarillos, or little cigars
- English- or Spanish-speaking
- Ability to provide meaningful consent
- Have registered for CT lung cancer screening at one of our five participating lung screening sites (for enrollment) and have completed CT lung cancer screening (for subsequent follow-ups).
- Current smokers are eligible to participate regardless of prior lung cancer screening or prior cessation treatment. Smokers not yet ready to quit will be encouraged to participate.
Exclusion Criteria:
- Previously diagnosed with lung cancer
- Diagnosed with lung cancer during the study (although still eligible to receive free telephone counseling and nicotine replacement)
- At the T1 assessment when randomization occurs, individuals who have been quit for 8+ days will not be randomized. We will request that they participate in follow-up assessments of smoking status at 3-, 6- and 12-months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intensive Telephone Counseling
This arm provides a multi-faceted, 8-session intensive telephone counseling (ITC) protocol, tailored on lung cancer screening results, with 8-weeks of free nicotine replacement patches provided (Nicoderm patch, 21mg, 14mg, and 7mg) and primary care engagement.
|
Participants are provided up to 8 counseling sessions lasting approximately 20 minutes each and access to 8-weeks of free nicotine replacement patches.
A counselor-initiated discussion of screening results will also be included throughout the counseling sessions.
|
Active Comparator: Usual Care
This arm provides a multi-faceted, 3-session usual care telephone counseling (UC) protocol, with 2-weeks of free nicotine replacement patches provided (Nicoderm patch, 21mg, 14mg, and 7mg) and primary care engagement.
|
Participants are provided up to 3 counseling sessions lasting approximately 20 minutes each and access to 2-weeks of free nicotine replacement patches.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Smoking cessation rate at 3-months post-randomization
Time Frame: Self-report measured at 3-months post-randomization; biochemical verification measured at 3-months.
|
Comparison between study arms of 7-day and 30-day point prevalence cessation with biochemical verification.
The investigators will also assess quit rates among subgroups (gender, age, nicotine dependence, site).
|
Self-report measured at 3-months post-randomization; biochemical verification measured at 3-months.
|
Smoking cessation rate at 6-months post-randomization
Time Frame: Self-report measured at 6-months post-randomization; biochemical verification measured at 6-months.
|
Comparison between study arms of 7-day and 30-day point prevalence cessation with biochemical verification.
The investigators will also assess quit rates among subgroups (gender, age, nicotine dependence, site).
|
Self-report measured at 6-months post-randomization; biochemical verification measured at 6-months.
|
Smoking cessation rate at 12-months post-randomization
Time Frame: Self-report measured at 12-months post-randomization; biochemical verification measured at 12-month assessment;
|
Comparison between study arms of 7-day and 30-day point prevalence cessation.
The investigators will also assess quit rates among subgroups (gender, age, nicotine dependence, site).
|
Self-report measured at 12-months post-randomization; biochemical verification measured at 12-month assessment;
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Readiness to quit
Time Frame: Measured at baseline (T0), 1-2 days post-receipt of screening result (T1), and 3-months (T2), 6-months (T3), and 12-months post-randomization (T4).
|
Measured using the 10-point contemplation ladder.
|
Measured at baseline (T0), 1-2 days post-receipt of screening result (T1), and 3-months (T2), 6-months (T3), and 12-months post-randomization (T4).
|
Quit attempts
Time Frame: Baseline (T0), 1-2 days post-receipt of screening result (T1),3-, 6- and 12- months post-randomization (T2, T3, T4)
|
The investigators will assess the number and length of prior quit attempts at baseline.
At all follow-up assessments, the investigators will assess the number and length of quit attempts that have occurred since the previous assessment.
|
Baseline (T0), 1-2 days post-receipt of screening result (T1),3-, 6- and 12- months post-randomization (T2, T3, T4)
|
TC intervention fidelity
Time Frame: Through study completion, an average of 3 months post-randomization.
|
Measurement of counselor adherence to the TC protocol, which will be assessed on 10% of randomly selected participants.
|
Through study completion, an average of 3 months post-randomization.
|
Patient reach and patient engagement
Time Frame: Through study completion, an average of 3 months post-randomization.
|
Reach: % of eligible smokers enrolled in trial; Engagement: % who receive the TC and the nicotine patch interventions), both overall and among subgroups (gender, age, nicotine dependence, site)
|
Through study completion, an average of 3 months post-randomization.
|
Costs per arm for study outcomes
Time Frame: Through study completion, an average of 3 months post-randomization.
|
Patient time costs in the interventions; fixed costs (space, overhead) and variable costs (intervention delivery and patient participation) by arm
|
Through study completion, an average of 3 months post-randomization.
|
Cigarettes smoked per day
Time Frame: Measured at baseline (T0), 1-2 days post-receipt of screening result (T1), 3-months post-randomization (T2), 6 months post randomization (T3) and 12 months post randomization (T4)
|
Number of cigarettes per day
|
Measured at baseline (T0), 1-2 days post-receipt of screening result (T1), 3-months post-randomization (T2), 6 months post randomization (T3) and 12 months post randomization (T4)
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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. Study protocol for a telephone-based smoking cessation randomized controlled trial in the lung cancer screening setting: The lung screening, tobacco, and health trial. Contemp Clin Trials. 2019 Jul;82:25-35. doi: 10.1016/j.cct.2019.05.006. Epub 2019 May 23.
- 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. A Randomized Trial of Telephone-Based Smoking Cessation Treatment in the Lung Cancer Screening Setting. J Natl Cancer Inst. 2022 Oct 6;114(10):1410-1419. doi: 10.1093/jnci/djac127.
- Cadham CJ, Cao P, Jayasekera J, Taylor KL, Levy DT, Jeon J, Elkin EB, Foley KL, Joseph A, Kong CY, Minnix JA, Rigotti NA, Toll BA, Zeliadt SB, Meza R, Mandelblatt J; CISNET-SCALE Collaboration. Cost-Effectiveness of Smoking Cessation Interventions in the Lung Cancer Screening Setting: A Simulation Study. J Natl Cancer Inst. 2021 Aug 2;113(8):1065-1073. doi: 10.1093/jnci/djab002.
- Cadham CJ, Jayasekera JC, Advani SM, Fallon SJ, Stephens JL, Braithwaite D, Jeon J, Cao P, Levy DT, Meza R, Taylor KL, Mandelblatt JS; CISNET-SCALE Collaboration. Smoking cessation interventions for potential use in the lung cancer screening setting: A systematic review and meta-analysis. Lung Cancer. 2019 Sep;135:205-216. doi: 10.1016/j.lungcan.2019.06.024. Epub 2019 Jul 6.
- Cao P, Smith L, Mandelblatt JS, Jeon J, Taylor KL, Zhao A, Levy DT, Williams RM, Meza R, Jayasekera J. Cost-Effectiveness of a Telephone-Based Smoking Cessation Randomized Trial in the Lung Cancer Screening Setting. JNCI Cancer Spectr. 2022 Jul 1;6(4):pkac048. doi: 10.1093/jncics/pkac048.
- Williams RM, Eyestone E, Smith L, Philips JG, Whealan J, Webster M, Li T, Luta G, Taylor KL, On Behalf Of The Lung Screening Tobacco Health Trial. Engaging Patients in Smoking Cessation Treatment within the Lung Cancer Screening Setting: Lessons Learned from an NCI SCALE Trial. Curr Oncol. 2022 Mar 23;29(4):2211-2224. doi: 10.3390/curroncol29040180.
- Williams RM, Cordon M, Eyestone E, Smith L, Luta G, McKee BJ, Regis SM, Abrams DB, Niaura RS, Stanton CA, Parikh V, Taylor KL; Lung Screening, Tobacco, Health Trial. Improved motivation and readiness to quit shortly after lung cancer screening: Evidence for a teachable moment. Cancer. 2022 May 15;128(10):1976-1986. doi: 10.1002/cncr.34133. Epub 2022 Feb 10.
- Eyestone E, Williams RM, Luta G, Kim E, Toll BA, Rojewski A, Neil J, Cinciripini PM, Cordon M, Foley K, Haas JS, Joseph AM, Minnix JA, Ostroff JS, Park E, Rigotti N, Sorgen L, Taylor KL. Predictors of Enrollment of Older Smokers in Six Smoking Cessation Trials in the Lung Cancer Screening Setting: The Smoking Cessation at Lung Examination (SCALE) Collaboration. Nicotine Tob Res. 2021 Nov 5;23(12):2037-2046. doi: 10.1093/ntr/ntab110.
- Kim E, Williams RM, Eyestone E, Cordon M, Smith L, Davis K, Luta G, Anderson ED, McKee B, Batlle J, Ramsaier M, Howell J, Parikh V, Geronimo M, Stanton C, Niaura R, Abrams D, Taylor KL; Lung Screening, Tobacco and Health Trial. Predictors of attrition in a smoking cessation trial conducted in the lung cancer screening setting. Contemp Clin Trials. 2021 Jul;106:106429. doi: 10.1016/j.cct.2021.106429. Epub 2021 May 6.
- Cordon M, Eyestone E, Hutchison S, Dunlap D, Smith L, Williams RM, Kim E, Kao JY, Hurtado-de-Mendoza A, Stanton C, Davis K, Frey J, McKee B, Parikh V, Taylor KL; Lung Screening, Tobacco, and Health Study. A qualitative study exploring older smokers' attitudes and motivation toward quitting during the COVID-19 pandemic. Prev Med Rep. 2021 Mar 11;22:101359. doi: 10.1016/j.pmedr.2021.101359. eCollection 2021 Jun.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Nicotine
Other Study ID Numbers
- 2016-0651
- R01CA207228-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tobacco Use
-
University of VirginiaVirginia Foundation for Healthy YouthRecruitingTobacco Use | Electronic Cigarette Use | Tobacco Use CessationUnited States
-
Vanderbilt University Medical CenterCompletedTobacco Use | Tobacco Use Cessation
-
Juul Labs, Inc.CompletedTobacco Use | Tobacco Smoking | Electronic Cigarette Use | Cigarette Use, ElectronicUnited States
-
Juul Labs, Inc.CompletedTobacco Use | Tobacco Smoking | Electronic Cigarette Use | Cigarette Use, ElectronicUnited States
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
-
Washington University School of MedicineNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Nicotine Dependence | Tobacco Dependence | Smoking, Tobacco | Nicotine Use Disorder | Nicotine Dependence, Cigarettes | Smoking, Cigarette | Nicotine Dependence Tobacco Product | Tobacco; Use, Rehabilitation | Smoking (Tobacco) Addiction and other conditionsUnited States
-
British American Tobacco (Investments) LimitedCompletedTobacco Use | Tobacco SmokingUnited States
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)RecruitingTobacco Use | Tobacco Smoking | Tobacco Use Disorder | Tobacco Use Cessation | Tobacco DependenceUnited States
-
Philip Morris Products S.A.CompletedSmoking | Tobacco Use | Tobacco SmokingUnited Kingdom
Clinical Trials on Intensive Telephone Counseling (8 sessions) with nicotine replacement
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)Completed
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedTobacco Use Disorder | Stage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Limited Stage Small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB...United States
-
H. Lee Moffitt Cancer Center and Research InstituteNational Cancer Institute (NCI)CompletedSmoking Cessation | Cervical Cancer | Tobacco UseUnited States
-
Soroka University Medical CenterNovartisUnknown
-
University of Wisconsin, MadisonNational Cancer Institute (NCI); Aurora Health Care; Dean Health System; Mercy...CompletedSmoking | Smoking Cessation | Nicotine Dependence | Motivation | AdherenceUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Completed
-
NYU Langone HealthCompleted
-
University of MinnesotaNational Cancer Institute (NCI)Completed
-
H. Lee Moffitt Cancer Center and Research InstituteCompletedSmoking | Tobacco Use | Lung CancerUnited States
-
Boston Medical CenterNational Cancer Institute (NCI)CompletedHIV Infections | Smoking CessationUnited States, China