This early phase I trial studies how well mobile health (mHealth) works in aiding participating in quitting smoking. Mobile health for smoking cessation may better help doctors gather information and understand what happens when attempting to quit smoking.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03404596.
PRIMARY OBJECTIVES:
I. Examine pathways linking “state” mindfulness (measured in real-time in the real-world via ecological momentary assessment [EMA]) to cessation (via AutoSense) with a longitudinal cohort study of a racially/ethnically diverse smokers.
II. Conduct a feasibility study to evaluate the potential efficacy of providing real-time, real-world mindfulness intervention strategies among a sample of racially/ethnically diverse smokers (original data collection).
OUTLINE:
STUDY I: Participants are assessed via EMA and AutoSense consisting of random assessment, assessments triggered by participants experiencing increased negative affect, and assessments triggered by participant smoking for 4 days pre-quit through 10 days post-quit (2 continuous weeks). Participants also receive nicotine patch and self-help materials for 6 weeks.
STUDY II: Participants receive cessation treatment according to Treating Tobacco Use and Dependence Clinical Practice Guideline, nicotine patch, and self-help materials for 6 weeks. Participants are monitored for smoking behavior via smartphone for 4 days prior to their quit day and for 10 days post-quit (14 continuous days). Participants also receive mindfulness strategies for 10 days post-quit via smartphone to aid in their cessation attempt.
Lead OrganizationMoffitt Cancer Center
Principal InvestigatorChristine Vinci
