CompletedPhase 3NCT03200236
Official study title

The Lung Screening, Tobacco and Health Project

Study 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.

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Key things to know

Main goalPrevention

This describes the study’s primary purpose.

What is being studiedIntensive Telephone Counseling (8 sessions) with nicotine replacement and Usual Care: Telephone counseling (3 sessions) with nicotine replacement

The study team can explain what participation involves.

Who it may be forSmoking, Tobacco · Tobacco-Related Carcinoma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 2, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?7 U.S. locations

Locations may change over time.

Who runs it?Georgetown University

Study sponsor

01
Study overview

What this study is about

Purpose
Prevention
Study type
Interventional
Phase
Phase 3
Sponsor
Georgetown University
Interventions being studied
Behavioral: Intensive Telephone Counseling (8 sessions) with nicotine replacement; Behavioral: Usual Care: Telephone counseling (3 sessions) with nicotine replacement
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Georgetown University Medical CenterWashington D.C., District of Columbia
  • Baptist Health South FloridaMiami, Florida
  • UnityPoint Health --Trinity Medical CenterMoline, Illinois
  • Anne Arundel Medical CenterAnnapolis, Maryland
  • MedStar Shah Medical GroupHollywood, Maryland
  • Lahey Hospital and Medical CenterBurlington, Massachusetts
  • Hackensack University Medical CenterHackensack, New Jersey

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 2, 2023. Always confirm current availability with the study team.

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