This phase III trial studies how well a tobacco intervention program works in improving smoking cessation in patients who are at risk for lung cancer. Tobacco intervention program combines standard care nicotine replacement therapy with personalized messages and biomarker feedback that may help to stop and prevent future smoking in patients who have been screened or may be eligible for lung cancer screening.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02658032.
PRIMARY OBJECTIVES:
I. To evaluate the efficacy of a personalized message intervention (Intervention 1) in improving tobacco quit rates above and beyond standard care tobacco treatment in patients who are screened for lung cancer or may be eligible for lung cancer screening.
II. To evaluate the efficacy of a novel, biofeedback-based intervention (Intervention 2) that provides personalized individual-level feedback on biomarkers of lung cancer risk and how they improve in response to cessation, delivered in a gain-framed way.
III. To evaluate the impact of smoking cessation on micro-ribonucleic acid (miRNA) profiles in human serum, especially miRNAs in the let-7 family, which are known to have tumor suppressor function, and which we hypothesize increase in response to cessation.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients attend standard care tobacco counseling sessions over 30-45 minutes for up to 5 sessions and also undergo nicotine replacement therapy and receive nicotine patches for up to 8 weeks.
GROUP II: Patients receive standard care tobacco counseling and nicotine replacement therapy as in group I. Patients also watch 4 personalized videos over 5-10 minute each and receive 5 packages of personalized written advice at counseling sessions.
Patients are randomized to 1 of 2 groups at week 8:
GROUP III: Patients receive biofeedback over 10-15 minutes at final counseling session and at 3-month visit.
GROUP IV: Patients receive no biofeedback until 6-month follow up.
After completion of study intervention patients are followed up at 3 and 6 months.
Lead OrganizationYale University
Principal InvestigatorBrenda Cartmel