RecruitingPhase 3NCT06290869

Tobacco Education and Lung Health Study (TEAL)

Providing Tobacco Treatment to Patients Undergoing Lung Cancer Screening at MedStar Health: A Randomized Trial (Tobacco Education and Lung Health Study)


Sponsor

Georgetown University

Enrollment

1,188 participants

Start Date

Feb 22, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 50 YearsMax Age: 80 Years

Inclusion Criteria5

  • 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 Criteria4

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

Interventions

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

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.

BEHAVIORALE-Referral to the Tobacco Quitline

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.


Locations(1)

Georgetown University Medical Center

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

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NCT06290869


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