Clinical trial NCT06290869: Tobacco Education and Lung Health Study (TEAL)
Official title: Providing Tobacco Treatment to Patients Undergoing Lung Cancer Screening at MedStar Health: A Randomized Trial (Tobacco Education and Lung Health Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Smoking Cessation
Keywords: high risk for lung cancer
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 1188
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Providing smoking cessation treatment in conjunction with the recently expanded lung cancer screening guidelines is estimated to substantially reduce lung cancer deaths and increase life-years gained compared to conducting lung screening alone. Although CMS recommends that individuals undergoing lung screening who currently smoke are offered cessation treatment, there are multiple barriers to treatment delivery. Improving the evidence-base of cessation treatment for patients undergoing lung screening and methods to promote the systematic uptake of cessation treatment into routine practice, particularly among diverse populations, is essential for realizing the maximum benefit of lung screening. Guided by the Practical, Robust, Implementation \& Sustainability framework, we will extend our prior work (CA R01207228). We propose a health system-level, pragmatic, randomized trial to compare the effectiveness of two evidence-based cessation treatments, with implementation strategies designed to address barriers to reach and engagement, particularly among underserved groups (e.g., racial and ethnic minority groups, underinsured patients, and patients not ready to quit) who are less likely to receive cessation treatment. To maximize generalizability to other health systems and to improve reach among heterogeneous groups, all patients scheduled at one of the 10 lung screening sites at MedStar Health, the largest and most diverse health system in the Mid-Atlantic, will be identified via the EHR, contacted for enrollment using an opt-out approach, and randomized to: 1) Quitline E-referral (QL-E; N=594) via the EHR and quitline integrated system, including proactive outreach and standard phone-based counseling + nicotine replacement provided by the quitline vs. 2) MedStar Health System (MHS; N=594), centralized, phone-based + NRT intervention adapted and improved from our prior trial, with a randomized stepped care intervention for those who are not abstinent at 3 months. Specific aims are: 1. To compare e-referral to the Quitline vs. the centralized Health System intervention. Primary outcomes are: 3-month self-reported abstinence from cigarettes and 6-month self-reported and bioverified abstinence from cigarettes. We will assess intervention mediators (e.g., treatment engagement) and moderators (e.g., readiness to quit) at 6-months. 2. To evaluate reach and engagement overall and by subgroup (e.g., race and ethnicity, underinsured, readiness to quit) and using mixed-methods to understand the contextual factors related to the feasibility and acceptability of the interventions and implementation strategies. 3. To conduct an economic analysis to evaluate costs, average and incremental cost per quit, and budget impact of the intervention at 3- and 6-months from the health system p0erspective. Proposal strengths include testing the effectiveness and economic outcomes of two cessation interventions while simultaneously laying the groundwork for future implementation within this and other diverse health systems. Our innovative approach capitalizes on the EHR for recruitment, provides multilevel training focused on diverse populations, and accounts for intervention context to inform future care delivery.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Biochemically verified smoking abstinence- MHS vs. QL-E arms
timeFrame: 6-month assessment
measure: Biochemically verified smoking abstinence--continued MHS arm vs Stepped Care
timeFrame: 6-month assessment
Secondary outcomes:
measure: self-reported smoking status
timeFrame: 3-month and 6-month assessments
measure: cigarettes per day
timeFrame: 3-month and 6-month assessments
measure: readiness to quit
timeFrame: 3-month and 6-month assessments
measure: Patient reach and patient engagement
timeFrame: Assessed through study completion, an average of six months.
measure: Costs per arm from the health system perspective
timeFrame: Assessed through study completion, an average of six months.
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
Study officials:
References: