Tobacco Education and Lung Health Study (TEAL)

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Georgetown University
Study ID
NCT06290869
Phase
PHASE3
Status
Recruiting
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Conditions

  • Smoking Cessation

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Feb 22, 2024
Status verified
Feb 2026
Primary completion
Dec 1, 2027
Completion
Mar 1, 2028

Study Design

Enrollment
1,188 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MedStar Health System
    Phone-based Tobacco Treatment, Nicotine Replacement, and Stepped Care Intervention
  • Active Comparator: E-Referral to the Tobacco Quitline
    Standard tobacco quitline protocol, including coaching, nicotine replacement, and web-, and text-based resources.

Primary Outcome Measure

Biochemically verified smoking abstinence- MHS vs. QL-E arms [ Time Frame: 6-month assessment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Georgetown University Medical CenterWashington D.C.District of Columbia20007
Kathryn L Taylor, PhD
[email protected]
2022159402

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