Health TrialsbyHealthPanel

Tobacco Education and Lung Health Study (TEAL)

ConditionSmoking Cessation
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50-80
SponsorGeorgetown University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

prior lung cancer,

hearing impairment,

cognitive impairment,

household member already enrolled.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

1,188 Participants
are divided into 2 treatment groups
Group A: MedStar Health SystemExperimental treatment 1 intervention
Group B: E-Referral to the Tobacco QuitlineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
6-month assessment
2

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

Time frame
6-month assessment

Secondary outcomes

1

self-reported smoking status

self-reported abstinence (defined as in the past 7 days and in the past 30 days)

Time frame
3-month and 6-month assessments
2

cigarettes per day

number of cigarettes smoked per day

Time frame
3-month and 6-month assessments
3

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)

Time frame
3-month and 6-month assessments
4

Patient reach and patient engagement

Reach: % of eligible smokers enrolled in trial; Engagement: % who receive the intervention, both overall and among subgroups

Time frame
Assessed through study completion, an average of six months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Georgetown University

Lead sponsor

Source ClinicalTrials.gov
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