This randomized phase II trial studies how well gain-framed messages and nicotine replacement therapy works in improving smoking cessation in patients undergoing lung cancer screening. Gain-framed messages are videos and personalized print materials that emphasize the benefits of smoking cessation. Nicotine replacement therapy includes nicotine patches and lozenges that may help patients quit smoking. Giving gain-framed messages and nicotine replacement therapy may work better in improving smoking cessation in patients undergoing lung cancer screening.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03069924.
PRIMARY OBJECTIVE:
I. To determine if the rate of smoking cessation among lung screening patients is improved by delivering gain-framed smoking cessation messages and delivery of a free starter package of medication (gain-framed behavioral intervention + 2 weeks of nicotine patches and lozenges versus [vs.] unframed behavioral intervention + no medication).
SECONDARY OBJECTIVE:
I. To evaluate if the rate of smoking cessation improved by delivery of nicotine replacement therapy (Any NRT vs. No NRT).
II. To evaluate if the rate of smoking cessation is improved by the delivery of gain-framed messaging (Any GF vs. Any unframed [UF] messaging).
III. To evaluate if the rate of smoking cessation is improved by any therapy (Any GF & Any NRT vs. UF + No NRT).
EXPLORATORY OBJECTIVES:
I. To examine mediators and moderators of treatment to determine mechanisms of treatment effects and which subgroups are most likely to respond to the gain-framed and medication interventions, and to explore differential effects of the study factors across treatment groups.
II. To examine additional treatment endpoints: patient reach, intervention fidelity, patient acceptance and engagement, cost, and the ease of delivery and feasibility.
OUTLINE: Patients are randomized to 1 of 4 groups.
GROUP A: Patients undergo a brief smoking cessation counseling session for 30-45 minutes.
GROUP B: Patients undergo a brief smoking cessation counseling session for 30-45 minutes and receive a 2-week starter pack of nicotine replacement therapy (NRT) consisting of a nicotine patch and nicotine lozenges.
GROUP C: Patients undergo a brief smoking cessation counseling session for 30-45 minutes, watch a gain-framed video for 10 minutes, and receive gain-framed personalized print materials weekly for 9 weeks.
GROUP D: Patients undergo a brief smoking cessation counseling session for 30-45 minutes, receive a 2-week starter pack of NRT consisting of a nicotine patch and nicotine lozenges, watch a gain-framed video for 10 minutes, and receive gain-framed personalized print materials weekly for 9 weeks.
After completion of study intervention, patients are followed up at 1, 3, and 6 months.
Lead OrganizationMedical University of South Carolina
Principal InvestigatorBenjamin Toll
