MedTrace Logo

Tobacco Education and Lung Health Study (TEAL)

NCT06290869 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1188

Last updated 2026-02-17

No results posted yet for this study

Summary

Primary Objective To compare two smoking cessation interventions among individuals undergoing lung cancer screening. Primary outcomes are: 3-month self-reported abstinence from cigarettes and 6-month self-reported and bioverified abstinence from cigarettes.

Secondary Objectives 1) To evaluate reach and engagement overall and by subgroup (e.g., race and ethnicity, underinsured, readiness to quit). 2) To conduct an economic analysis to evaluate intervention costs from the health system perspective.

Conditions

  • Smoking Cessation

Interventions

BEHAVIORAL

Phone-based Tobacco Treatment, Nicotine Replacement, and Stepped Care Intervention

In the MedStar Health System (MHS) arm, we offer 5 phone sessions with a tobacco treatment specialist (TTS) during the first 3 months of treatment plus combination nicotine replacement (patches and lozenges). For those who have not quit at 3 months, 50% will be randomly assigned to stepped care (3 phone sessions with RN/NP + prescription medications as needed) vs. the continued TTS + NRT intervention. Those who have quit at 3 months will be offered 3 relapse prevention phone sessions with the TTS. Thus, all are offered 8 sessions. The TTS will use motivational interviewing to address ambivalence about quitting, education about the risks of continued smoking, encouragement to use and adhere to NRT, and the impact of the screening result (the teachable moment) by framing it as a potential motivator or opportunity to reduce future health risks and to maximize quality of life.

BEHAVIORAL

E-Referral to the Tobacco Quitline

In the Quitline E-Referral arm, an e-referral will be generated from the EHR by our staff, will be signed by the LCS ordering provider and sent to the quitline through the closed-looped quitline's success.58-61,123 The quitline is an important comparator, given that it is an evidence-based and low-cost intervention already employed by many LCS sites system and the standard quitline protocol will then occur: 5 proactive contact attempts, up to 5 sessions, and up to 8 weeks of free NRT (depending on supplies). Quitline counselors are highly trained to conduct cessation treatment and extensive research has validated the quitline's success. The quitline is an important comparator, given that it is an evidence-based and low-cost intervention already employed by many LCS sites.

Sponsors & Collaborators

  • Georgetown University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-22
Primary Completion
2027-12-01
Completion
2028-03-01

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06290869 on ClinicalTrials.gov