Clinical trial NCT03200236: The Lung Screening, Tobacco and Health Project
Official title: Integrating Evidence-Based Smoking Cessation Interventions Into Lung Cancer Screening Programs: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking, Tobacco
Tobacco-Related Carcinoma
Tobacco Use
Lung Cancer Screening
Keywords: Lung Cancer Screening
Smoking Cessation
Tobacco Use
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: Hackensack Meridian Health
name: Baptist Health South Florida
name: Lahey Hospital & Medical Center
name: University of Michigan
name: National Cancer Institute (NCI)
name: Unity Point Health
name: MedStar Shah Medical Group
name: Anne Arundel Medical Center
First posted: 2017-06-27
Enrollment: 1114
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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:

1. 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.
2. 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.
3. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Smoking cessation rate at 3-months post-randomization
timeFrame: Self-report measured at 3-months post-randomization; biochemical verification measured at 3-months.
measure: Smoking cessation rate at 6-months post-randomization
timeFrame: Self-report measured at 6-months post-randomization; biochemical verification measured at 6-months.
measure: Smoking cessation rate at 12-months post-randomization
timeFrame: Self-report measured at 12-months post-randomization; biochemical verification measured at 12-month assessment;
Secondary outcomes:
measure: Readiness to quit
timeFrame: 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).
measure: Quit attempts
timeFrame: Baseline (T0), 1-2 days post-receipt of screening result (T1),3-, 6- and 12- months post-randomization (T2, T3, T4)
measure: TC intervention fidelity
timeFrame: Through study completion, an average of 3 months post-randomization.
measure: Patient reach and patient engagement
timeFrame: Through study completion, an average of 3 months post-randomization.
measure: Costs per arm for study outcomes
timeFrame: Through study completion, an average of 3 months post-randomization.
measure: Cigarettes smoked per day
timeFrame: 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)
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Miami
country: United States
facility: Baptist Health South Florida
state: Florida
city: Moline
country: United States
facility: UnityPoint Health --Trinity Medical Center
state: Illinois
city: Annapolis
country: United States
facility: Anne Arundel Medical Center
state: Maryland
city: Hollywood
country: United States
facility: MedStar Shah Medical Group
state: Maryland
city: Burlington
country: United States
facility: Lahey Hospital and Medical Center
state: Massachusetts
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
Study officials:
References:
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