Lombardi Comprehensive Cancer Center/Legacy Pilot Study to Reduce Adverse Smoking Outcomes in the Context of Lung Cancer Screening



Status:Active, not recruiting
Conditions:Lung Cancer, Cancer, Smoking Cessation
Therapuetic Areas:Oncology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:55 - 80
Updated:4/21/2016
Start Date:January 2014
End Date:August 2016

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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.

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.

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 -
We found this trial at
3
sites
3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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Burlington, Massachusetts 01805
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Burlington, MA
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hackensack, NJ
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