Tobacco Education and Lung Health Study (TEAL)

NCT06290869 | Recruiting Phase 3

• 1 other identifier: STUDY00006070
• Study Type: interventional
• Target: 1,188
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

high risk for lung cancer

Outcome Measures

Primary Outcomes (2)

• Biochemically verified smoking abstinence- MHS vs. QL-E arms

  Biochemically verified 7-day point prevalence abstinence rates, comparing the Health System (MHS) arm and the Quitline (QL-E) arm

  6-month assessment

• Biochemically verified smoking abstinence--continued MHS arm vs Stepped Care

  Biochemically verified 7-day abstinence rates between the Stepped Care arm and the Continued MHS arm

  6-month assessment

Secondary Outcomes (5)

• self-reported smoking status

  3-month and 6-month assessments

• cigarettes per day

  3-month and 6-month assessments

• readiness to quit

  3-month and 6-month assessments

• Patient reach and patient engagement

  Assessed through study completion, an average of six months.

• Costs per arm from the health system perspective

  Assessed through study completion, an average of six months.

Study Arms (2)

MedStar Health System

EXPERIMENTAL

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

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

E-Referral to the Tobacco Quitline

ACTIVE COMPARATOR

Standard tobacco quitline protocol, including coaching, nicotine replacement, and web-, and text-based resources.

Behavioral: E-Referral to the Tobacco Quitline

Interventions

E-Referral to the Tobacco Quitline BEHAVIORAL

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.

E-Referral to the Tobacco Quitline

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

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.

MedStar Health System

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• eligible for a screening or diagnostic scan,
• USPSTF eligibility criteria (50-80 years old and \>20-pack years);
• currently smoking cigarettes (\>1 in the past 30 days);
• English speaking;
• able to provide meaningful consent.

You may not qualify if:

• prior lung cancer,
• hearing impairment,
• cognitive impairment,
• household member already enrolled.

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

RECRUITING

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Central Study Contacts

Kathryn L Taylor, PhD

CONTACT

2022159402; taylorkl@georgetown.edu

Randi M. Williams, PhD

CONTACT

rmw27@georgetown.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: March 4, 2024
• Study Start: February 22, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)