This clinical trial is being done to see if tobacco treatment with LungHealth and Stepped Care is better at improving smoking cessation in patients that smoke who are undergoing lung cancer screening. Smoking cessation treatment is recommended for individuals undergoing lung screening who currently smoke, but there are many barriers to treatment delivery. LungHealth uses telephone counseling that includes motivational interviewing to review treatment options and make a quit smoking plan using nicotine replacement therapy (NRT) with nicotine patches and lozenges. Quitline uses telephone counseling with a tobacco treatment specialist (TTS) to review treatment options and make a quit smoking plan using NRT. NRT with nicotine patches and lozenges gives small, steady doses of nicotine to help stop cravings and relieve symptoms that occur when a person is trying to quit smoking (withdrawal). Stepped Care uses coaching calls with a registered nurse (RN) or nurse practitioner (NP) to consider prescription medications (varenicline or bupropion) to help with quitting. Varenicline and bupropion are drugs used to help people quit smoking by helping reduce cravings and withdrawal. Tobacco treatment with LungHealth and Stepped Care may be effective in improving smoking cessation in patients undergoing lung cancer screening that smoke.
Additional locations may be listed on ClinicalTrials.gov for NCT06290869.
Locations matching your search criteria
United States
District of Columbia
Washington
MedStar Georgetown University HospitalStatus: Active
Contact: Kathryn Taylor
Phone: 202-687-0649
PRIMARY OBJECTIVES:
I. To compare abstinence (self-reported and bioverified) by study arm.
II. To evaluate reach (% of eligible patients offered trial enrollment) and engagement (% of enrolled patients who received treatment) by subgroup (e.g., race/ethnicity, insurance coverage, readiness to quit).
III. To conduct an economic analysis to evaluate costs, average and incremental cost per quit, and budget impact at 3- and 6-months from MedStar’s perspective.
OUTLINE: All patients are randomized to LungHealth group or Quitline group.
LUNGHEALTH GROUP: Patients participate in 5 phone calls with TTS lasting 20 minutes over 3 months. Patients are also offered a 4-week supply of NRT with nicotine patches and/or lozenges for 8 weeks. Patients that have quit smoking at 3 months may participate in an additional 3 phone calls with TTS as well as continue with NRT if needed. Participants that have not quit smoking at 3 months are randomized to the LungHealth Continued or Stepped Care groups below.
QUITLINE GROUP: Patients participate in 5 phone calls with a Quitline counselor lasting 20 minutes over 3 months. Patients are also offered a 4-week supply of NRT with nicotine patches and/or lozenges.
LUNGHEALTH CONTINUED: Patients participate in 3 phone calls with TTS lasting 20 minutes and receive NRT with nicotine patches and/or lozenges if needed.
STEPPED CARE GROUP: Patients participate in 3 coaching phone calls with RN/NP and receive varenicline, bupropion, or NRT with nicotine patches and lozenges.
Lead OrganizationMedStar Georgetown University Hospital
Principal InvestigatorKathryn Taylor