Smoking, TobaccoPhase 3NCT03200236
The Lung Screening, Tobacco and Health Project
A Phase 3 study testing Intensive Telephone Counseling (8 sessions) with nicotine replacement in people with Smoking, Tobacco and Tobacco-Related Carcinoma, run by Georgetown University at 7 sites in United States.
Trial summary
The purpose of this study is to compare intensive telephone counseling (ITC) plus the nicotine patch vs. standard telephone counseling plus the nicotine patch (Usual Care; UC) among current smokers undergoing lung cancer screening. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Tobacco, Tobacco-Related Carcinoma, Tobacco Use
- What is being tested?
- Intensive Telephone Counseling (8 sessions) with nicotine replacement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,114 participants
- Where
- 7 sitesUnited States
- Study dates
- 3 May 2017to 30 Jan 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Anne Arundel Medical Center
Annapolis, Maryland, 21401
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
Hackensack University Medical Center
Hackensack, New Jersey, 07601
MedStar Shah Medical Group
Hollywood, Maryland, 20636
Baptist Health South Florida
Miami, Florida, 33176
UnityPoint Health --Trinity Medical Center
Moline, Illinois, 61265
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
Official title: Integrating Evidence-Based Smoking Cessation Interventions Into Lung Cancer Screening Programs: A Randomized Trial
The purpose of this study is to compare intensive telephone counseling (ITC) plus the nicotine patch vs. standard telephone counseling plus the nicotine patch (Usual Care; UC) among current smokers undergoing lung cancer screening. Smoking-related outcomes will be examined at three, six and twelve months post-randomization.
Read the 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.
- Being tested
- Intensive Telephone Counseling (8 sessions) with nicotine replacement, Usual Care: Telephone counseling (3 sessions) with nicotine replacement
- Keywords
- Lung Cancer Screening, Smoking Cessation, Tobacco Use
- Medical subject headings
- Tobacco Smoking, Tobacco Use, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Telephone Counseling (8 sessions) with nicotine replacementBehavioural
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.
Usual Care: Telephone counseling (3 sessions) with nicotine replacementBehavioural
Participants are provided up to 3 counseling sessions lasting approximately 20 minutes each and access to 2-weeks of free nicotine replacement patches.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Telephone Counseling | Experimental | 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. Receives: Behavioral: Intensive Telephone Counseling (8 sessions) with nicotine replacement |
| Usual Care | Active comparator | 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. Receives: Behavioral: Usual Care: Telephone counseling (3 sessions) with nicotine replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation rate at 3-months post-randomization
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).
Measured: Self-report measured at 3-months post-randomization; biochemical verification measured at 3-months.
Smoking cessation rate at 6-months post-randomization
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).
Measured: Self-report measured at 6-months post-randomization; biochemical verification measured at 6-months.
Smoking cessation rate at 12-months post-randomization
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).
Measured: Self-report measured at 12-months post-randomization; biochemical verification measured at 12-month assessment;
Secondary outcomes (6)
Readiness to quit
Measured using the 10-point contemplation ladder.
Measured: 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
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.
Measured: Baseline (T0), 1-2 days post-receipt of screening result (T1),3-, 6- and 12- months post-randomization (T2, T3, T4)
TC intervention fidelity
Measurement of counselor adherence to the TC protocol, which will be assessed on 10% of randomly selected participants.
Measured: Through study completion, an average of 3 months post-randomization.
Patient reach and patient engagement
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)
Measured: Through study completion, an average of 3 months post-randomization.
Costs per arm for study outcomes
Patient time costs in the interventions; fixed costs (space, overhead) and variable costs (intervention delivery and patient participation) by arm
Measured: Through study completion, an average of 3 months post-randomization.
Cigarettes smoked per day
Number of cigarettes per day
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start3 May 2017
- Primary completion30 Jan 2021
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Smoking, TobaccoStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Hackensack Meridian Health, Baptist Health South Florida, Lahey Hospital & Medical Center, University of Michigan, National Cancer Institute (NCI), Unity Point Health, MedStar Shah Medical Group, Anne Arundel Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200236
- Sponsor's protocol ID
- 2016-0651
- Other IDs
- R01CA207228-01
- Status last verified
- Mar 2023
- First submitted
- 19 Jun 2017
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified patient data will be shared with the National Cancer Institute as part of the SCALE collaboration.
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.
PubMed 31129371Cadham 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.
PubMed 33484569Cadham 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.
PubMed 31446996Taylor 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.
PubMed 35818122Cao 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.
PubMed 35818125Williams 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.
PubMed 35448154Williams 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.
PubMed 35143041Eyestone 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.
PubMed 34077535Kim 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.
PubMed 33964415Cordon 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.
PubMed 33868901
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Evidence-Based Smoking Cessation Interventions Into Lung Cancer Screening Programs: A Randomized Trial
- ClinicalTrials.gov ID
- NCT03200236
- Acronym / sponsor ID
- 2016-0651
- Keywords
- Lung Cancer Screening, Smoking Cessation, Tobacco Use
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,114 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Hackensack Meridian Health, Baptist Health South Florida, Lahey Hospital & Medical Center, University of Michigan, National Cancer Institute (NCI), Unity Point Health, MedStar Shah Medical Group, Anne Arundel Medical Center
- Study start
- 3 May 2017 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 27 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare intensive telephone counseling (ITC) plus the nicotine patch vs. standard telephone counseling plus the nicotine patch (Usual Care; UC) among current smokers undergoing lung cancer screening. Smoking-related outcomes will be examined at three, six and twelve months post-randomization.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Telephone Counseling | Experimental | Behavioral: Intensive Telephone Counseling (8 sessions) with nicotine replacementThis 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. |
| Usual Care | Active comparator | Behavioral: Usual Care: Telephone counseling (3 sessions) with nicotine replacementThis 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Telephone Counseling (8 sessions) with nicotine replacementParticipants 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. | Behavioural | Intensive Telephone Counseling |
| Usual Care: Telephone counseling (3 sessions) with nicotine replacementParticipants are provided up to 3 counseling sessions lasting approximately 20 minutes each and access to 2-weeks of free nicotine replacement patches. | Behavioural | Usual Care |
Primary outcome
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).
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).
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).
6 secondary outcomes
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).
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)
TC intervention fidelity
Time frame: 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.
Costs per arm for study outcomes
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Background: PubMed 31129371Taylor 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.
- Background: PubMed 33484569Cadham 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.
- Background: PubMed 31446996Cadham 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.
- Results publication: PubMed 35818122Taylor 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.
- Results publication: PubMed 35818125Cao 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.
- Results publication: PubMed 35448154Williams 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.
- Results publication: PubMed 35143041Williams 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.
- Results publication: PubMed 34077535Eyestone 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.
- Results publication: PubMed 33964415Kim 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.
- Results publication: PubMed 33868901Cordon 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.
- Individual participant dataSharing planned: Yes. Deidentified patient data will be shared with the National Cancer Institute as part of the SCALE collaboration.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intensive Telephone Counseling (8 sessions) with nicotine replacement in people with Smoking, Tobacco and Tobacco-Related Carcinoma, run by Georgetown University at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking cessation rate at 3-months post-randomization (time frame: Self-report measured at 3-months post-randomization; biochemical verification measured at 3-months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03200236, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.