Lombardi Comprehensive Cancer Center/Legacy Pilot Study to Reduce Adverse Smoking Outcomes in the Context of Lung Cancer Screening
Condition: Smoking; Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      In 2011, the National Lung Screening Trial (NLST) reported that lung cancer mortality was
      reduced by 20% with spiral computed tomography (CT) compared to chest X-ray. It is estimated
      that 8 million people in the US are at high risk for lung cancer and that lung screening
      could prevent 12,000 deaths annually. Cost effectiveness models suggest that concurrent
      smoking cessation programs will be essential in order to realize the full benefit of
      screening. However, there are no clinical guidelines or evidence-based cessation protocols
      with demonstrated effectiveness in this setting. The investigators are addressing this gap by
      rigorously testing whether two scalable and pragmatic interventions can significantly boost
      intention to quit and cessation rates.
    

Detailed description: 
      Although abstinence from tobacco remains the best method of lung cancer prevention, recent
      evidence from the National Lung Screening Trial indicated that lung cancer mortality was
      reduced by 20% with spiral computed tomography (CT) compared to chest X-ray. As a result, the
      United States Preventive Services Task Force now recommends lung cancer screening for high
      risk individuals (long-term current and former smokers, 55-80 years old). It is estimated
      that 8 million people in the US are at high risk and that lung screening could prevent 12,000
      deaths annually. Cost effectiveness models suggest that concurrent smoking cessation programs
      will be essential in order to realize the full benefit of screening. However, there are no
      clinical guidelines or evidence-based cessation protocols with demonstrated effectiveness in
      this setting. The investigators propose to address this gap by rigorously testing whether two
      scalable and pragmatic interventions (minimal and moderate in intensity) can significantly
      boost intention to quit and cessation rates. The investigators will capitalize on the
      critical 'teachable moment' of learning of one's screening result. Incorporation of an
      individual's screening result into a cessation intervention will test the innovative question
      of whether intention to quit can be enhanced and reduced intention to quit can be minimized,
      when an individualized, motivational telephone-based intervention is provided. Method: The
      investigators will accrue current smokers from the lung cancer screening programs at three
      sites: Georgetown University Hospital, Lahey Hospital, and Hackensack University Hospital.
      Prior to screening, 100 participants will be consented, enrolled, and will complete the
      baseline (T0) phone interview. Within 1-2 days of receiving the result, participants will be
      randomly assigned to Minimal Treatment (MT) vs. Telephone Counseling (TC). Both arms will
      receive the minimal treatment intervention (a list of print, online, quitline, and in-person
      cessation resources). The TC arm will receive 3-6 sessions of stepped-care, proactive,
      telephone counseling with the same Tobacco Treatment Specialist for both sites. Both arms
      will be assessed at 3-months post randomization for tobacco use outcomes. The specific aims
      are: 1) To conduct a two-arm randomized cessation intervention trial (MT vs. TC) with current
      smokers undergoing screening. 2) The investigators will explore moderators and mediators of
      the interventions' effect on cessation outcomes. Moderators include the screening result,
      race, gender, age, and nicotine dependence. Mediators include teachable moment factors,
      baseline intention to quit, and process measures. Summary: This proof of concept study will
      determine intervention feasibility, effect sizes needed for a larger study, and potential
      moderators and mediators of the intervention. The long-term goal is to evaluate the
      intervention in a multisite trial and ultimately, to disseminate it for use by lung cancer
      screening programs. The innovation of this proposal is in joining disease prevention (smoking
      cessation) with early detection in a medical setting that has relevance for a substantial
      proportion of current smokers, suggesting that even a small increase in cessation has the
      potential for a very large public health benefit.
    

Intervention name(s): Telephone Counseling; Minimal Treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The TC arm includes a stepped care approach, 3-6 phone sessions, depending on each participant's needs. Within 1-2 days post-T1 assessment, the intervention will begin. Sessions 1-3 (15 min each) will occur approximately weekly over 3-4 weeks, scheduled at participants' convenience and at strategic therapeutic times (e.g., shortly pre/post-quit date). Continuing smokers or newly quit former smokers who would benefit from relapse prevention sessions will receive up to 3 additional sessions, to be completed within 3-4 weeks. The provision of 3-6 sessions is more intensive than several other telephone counseling interventions. A dose response relationship between quitting and number of sessions has been shown in non-volunteer smokers, and based on our pilot data, the investigators expect that a more intensive intervention will be needed for some participants.; A list of self-help materials (print-, web-, phone-based), the national telephone quitline phone number, and local in person cessation resources will be given to all participants.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lung cancer screening