The Lung Screening, Tobacco and Health Project
Condition: Smoking, Tobacco; Tobacco-Related Carcinoma; Tobacco Use; Lung Cancer Screening
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Intensive Telephone Counseling (8 sessions) with nicotine replacement; Usual Care: Telephone counseling (3 sessions) with nicotine replacement
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; Participants are provided up to 3 counseling sessions lasting approximately 20 minutes each and access to 2-weeks of free nicotine replacement patches.
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Lung Cancer Screening; Smoking Cessation; Tobacco Use