Lombardi Comprehensive Cancer Center/Legacy Pilot Study to Reduce Adverse Smoking Outcomes in the Context of Lung Cancer Screening
Conditions
Smoking - Lung Cancer
Conditions: official terms
Lung Neoplasms
Conditions: Keywords
lung cancer screening
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Telephone Counseling Type: Behavioral
Name: Minimal Treatment Type: Behavioral
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: 80 Years
Minimum Age: 55 Years
Gender: Both
Criteria: Inclusion Criteria:

1. 55-80 years old

2. current smoker

3. > 30-pack years

4. English-speaking

5. ability to provide meaningful consent

6. enrolled to undergo lung cancer screening. -

Exclusion Criteria:

1. history of lung cancer

2. current treatment for other cancer -
Locations
Georgetown University Medical Center
Washington, District of Columbia, United States
Status: Recruiting
Contact: Kathryn L. Taylor, PhD - 202-687-0649 - taylorkl@georgetown.edu
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Status: Recruiting
Contact: Shawn Regis, PhD - shawn.m.regis@lahey.org
Hackensack University Medical Center
Hackensack, New Jersey, United States
Status: Recruiting
Contact: Stephanie Concannon - sconcannon@hackensackumc.org
Start Date
January 2014
Completion Date
December 2015
Sponsors
Georgetown University
Source
Georgetown University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page