Smoking CessationPhase 3TEALNCT06290869
Tobacco Education and Lung Health Study (TEAL)
A Phase 3 study testing Phone-based Tobacco Treatment, Nicotine Replacement, and Stepped Care Intervention and E-Referral to the Tobacco Quitline in people with Smoking Cessation, run by Georgetown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Phone-based Tobacco Treatment, Nicotine Replacement, and Stepped Care Intervention and E-Referral to the Tobacco Quitline
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,188 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2024to 1 Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- prior lung cancer,
- hearing impairment,
- cognitive impairment,
- household member already enrolled.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Randi M. Williams, PhD contact
United States1 site, 1 recruiting
- Recruiting
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Kathryn L Taylor, PhD, 2022159402, taylorkl@georgetown.edu
About this study
Official title: Providing Tobacco Treatment to Patients Undergoing Lung Cancer Screening at MedStar Health: A Randomized Trial (Tobacco Education and Lung Health Study)
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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Phone-based Tobacco Treatment, Nicotine Replacement, and Stepped Care Intervention, E-Referral to the Tobacco Quitline
- Keywords
- high risk for lung cancer
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone-based Tobacco Treatment, Nicotine Replacement, and Stepped Care InterventionBehavioural
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 QuitlineBehavioural
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 group | Role | What they receive |
|---|---|---|
| MedStar Health System | Experimental | Phone-based Tobacco Treatment, Nicotine Replacement, and Stepped Care Intervention Receives: 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. Receives: Behavioral: E-Referral to the Tobacco Quitline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6-month assessment
Secondary outcomes (5)
self-reported smoking status
self-reported abstinence (defined as in the past 7 days and in the past 30 days)
Measured: 3-month and 6-month assessments
cigarettes per day
number of cigarettes smoked per day
Measured: 3-month and 6-month assessments
readiness to quit
readiness to quit (defined as ready to quit in the next 30 days, the next six months, or not ready to quit)
Measured: 3-month and 6-month assessments
Patient reach and patient engagement
Reach: % of eligible smokers enrolled in trial; Engagement: % who receive the intervention, both overall and among subgroups
Measured: Assessed through study completion, an average of six months.
Costs per arm from the health system perspective
Staff time costs; fixed costs, and variable costs
Measured: Assessed through study completion, an average of six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start22 Feb 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathryn L. Taylor, Ph.D., Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290869
- Sponsor's protocol ID
- STUDY00006070
- Acronym
- TEAL
- Status last verified
- Feb 2026
- First submitted
- 15 Feb 2024
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Providing Tobacco Treatment to Patients Undergoing Lung Cancer Screening at MedStar Health: A Randomized Trial (Tobacco Education and Lung Health Study)
- ClinicalTrials.gov ID
- NCT06290869
- Acronym / sponsor ID
- TEAL / STUDY00006070
- Conditions
- Smoking Cessation
- Keywords
- high risk for lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,188 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MedStar Health System | Experimental | Behavioral: Phone-based Tobacco Treatment, Nicotine Replacement, and Stepped Care InterventionPhone-based Tobacco Treatment, Nicotine Replacement, and Stepped Care Intervention |
| E-Referral to the Tobacco Quitline | Active comparator | Behavioral: E-Referral to the Tobacco QuitlineStandard tobacco quitline protocol, including coaching, nicotine replacement, and web-, and text-based resources. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- prior lung cancer,
- hearing impairment,
- cognitive impairment,
- household member already enrolled.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone-based Tobacco Treatment, Nicotine Replacement, and Stepped Care InterventionIn 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. | Behavioural | MedStar Health System |
| E-Referral to the Tobacco QuitlineIn 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. | Behavioural | E-Referral to the Tobacco Quitline |
Primary outcome
Biochemically verified smoking abstinence- MHS vs. QL-E arms
Time frame: 6-month assessment
Biochemically verified 7-day point prevalence abstinence rates, comparing the Health System (MHS) arm and the Quitline (QL-E) arm
Biochemically verified smoking abstinence--continued MHS arm vs Stepped Care
Time frame: 6-month assessment
Biochemically verified 7-day abstinence rates between the Stepped Care arm and the Continued MHS arm
5 secondary outcomes
self-reported smoking status
Time frame: 3-month and 6-month assessments
cigarettes per day
Time frame: 3-month and 6-month assessments
readiness to quit
Time frame: 3-month and 6-month assessments
Patient reach and patient engagement
Time frame: Assessed through study completion, an average of six months.
Costs per arm from the health system perspective
Time frame: Assessed through study completion, an average of six months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Randi M. Williams, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Phone-based Tobacco Treatment, Nicotine Replacement, and Stepped Care Intervention and E-Referral to the Tobacco Quitline in people with Smoking Cessation, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathryn L Taylor, PhD (2022159402, taylorkl@georgetown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically verified smoking abstinence- MHS vs. QL-E arms (time frame: 6-month assessment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.