Nicotine Patches, Nicotine Lozenges, Individualized Quitting Messages, and Motivational Interviewing at Lung Cancer Screening Sites in Helping Current Smokers Reduce or Quit Smoking, CASTL study

Summary

Objectives

PRIMARY OBJECTIVES:
I. To use a highly efficient Multiphase Optimization Strategy (MOST) design to identify which of four evidence-based tobacco treatment components contribute to superior cessation endpoints among current smokers seeking lung cancer screening.
II. To estimate the cost and incremental cost-effectiveness of evidence-based tobacco treatment components, delivered alone and in combination.
III. To conduct a robust, mixed methods evaluation of the implementation process and assess organizational factors that may influence dissemination and implementation of delivering effective models for smoking cessation treatment in lung cancer screening settings.
IV. To gain a better understanding of factors impacting refusal among African-American smokers using a rigorous qualitative approach. (PACT ancillary study)

OUTLINE: Participants are randomized to 1 of 16 groups. African-Americans who refuse participation in the study, are assigned to the Sub-Study arm.

GROUP 1: Participants receive a printed individualized quitting message that emphasizes the risks of continuing to smoke (loss-framed) and receive two motivational interviewing counseling sessions, the first delivered face to face or via telephone by the study coordinator (SC) during the participant’s initial lung cancer screening visit or within 1 week after the screening visit and the second session delivered via telephone by the SC 4-8 weeks after the first session. Patients also receive enhanced standard of care consisting of self-help cessation materials and referral to the Quitline.

GROUP 2: Participants receive a printed individualized quitting message that emphasizes the benefits of quitting (gain-framed) and receive motivational interviewing counseling sessions enhanced standard of care as in Group 1.

GROUP 3: Participants receive loss-framed message, motivational interviewing, and enhanced standard of care as in Group 1. Participants also receive six weeks of nicotine replacement therapy (NRT) patch (over the counter).

GROUP 4: Participants receive gain-framed message as in Group 2, motivational interviewing and enhanced standard of care as in Group 1, and six weeks of NRT patch as in Group 3.

GROUP 5: Participants receive loss-framed message, motivational interviewing, and enhanced standard of care as in Group 1. Participants also receive six packs of NRT lozenge with written instructions to use the lozenge as needed (pro re nata [PRN]) to help manage acute nicotine withdrawal.

GROUP 6: Participants receive gain-framed message as in Group 2, six packs of NRT lozenge as in Group 5, and motivational interviewing and enhanced standard of care as in Group 1.

GROUP 7: Participants receive loss-framed message, motivational interviewing, and enhanced standard of care as in Group 1. Participants also receive six weeks of NRT patch as in Group 3, and six packs of NRT lozenge as in Group 5.

GROUP 8: Participants receive gain-framed message as in Group 2, motivational interviewing and enhanced standard of care as in Group 1, six weeks of NRT patch as in Group 3, and six packs of NRT lozenge as in Group 5.

GROUP 9: Participants receive loss-framed message and enhanced standard of care as in Group 1.

GROUP 10: Participants receive gain-framed message as in Group 2 and enhanced standard of care as in Group 1.

GROUP 11: Participants receive loss-framed message and enhanced standard of care as in Group 1. Participants also receive six weeks of NRT patch as in Group 3.

GROUP 12: Participants receive gain-framed message as in Group 2, enhanced standard of care as in Group 1, and six weeks of NRT patch as in Group 3.

GROUP 13: Participants receive loss-framed message and enhanced standard of care as in Group 1. Participants also receive six packs of NRT lozenge as in Group 5.

GROUP 14: Participants receive gain-framed message as in Group 2, enhanced standard of care as in Group 1, and six packs of NRT lozenge as in Group 5.

GROUP 15: Participants receive loss-framed message and enhanced standard of care as in Group 1. Participants also receive six weeks of NRT patch as in Group 3 and six packs of NRT lozenge as in Group 5.

GROUP 16: Participants receive gain-framed message as in Group 2, enhanced standard of care as in Group 1, six weeks of NRT patch as in Group 3 and six packs of NRT lozenge as in Group 5.

After completion of study, participants are followed up at 3 and 6 months.

SUB-STUDY: Participants complete an interview over 30 minutes.