This phase III trial studies how well culturally-tailored internet-based smoking cessation program works in quitting smoking in tribal college students. A culturally-tailored internet-based quit smoking program that recognizes and respects traditional tobacco use and other important aspects of American Indian culture may help quit smoking.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02050308.
PRIMARY OBJECTIVES:
I. To test the effectiveness of a culturally-tailored internet-based smoking cessation intervention (I-ANBL) compared to an internet-based heart healthy diet (I-FV: fruit/vegetable) control condition in a randomized controlled trial with tribal college students.
SECONDARY OBJECTIVES:
I. To test the effects of the intervention on intermediate smoking variables including number of cigarettes smoked and number of quit attempts at 6 months following randomization.
II. To compare differences between I-ANBL and I-FV in adherence rates to program participation at 6 months following randomization.
TERTIARY OBJECTIVES:
I. To identify factors that enhance the dissemination aspects of the I-ANBL program.
II. To evaluate the costs of delivering the tailored intervention.
III. To examine potential moderators of the intervention and cessation relationship.
OUTLINE:
PHASE I: Develop and assess interactive website via focus groups over 60-90 minutes.
PHASE II: Participants are randomized into 1 of 2 arms.
ARM I: Participants complete weekly I-ANBL web sessions over 30 minutes each on weeks 1-8 and 12. Participants have the choice of receiving varenicline, bupropion hydrochloride, nicotine replacement therapy, or no pharmacotherapy.
ARM II: Participants complete weekly I-FV web sessions over 30 minutes each on weeks 1-8 and 12. Participants have the choice of receiving varenicline, bupropion hydrochloride, nicotine replacement therapy, or no pharmacotherapy.
After completion of study, participants are followed up at 6 months.
Lead OrganizationUniversity of Kansas Cancer Center
Principal InvestigatorWon Choi