This phase III trial compares a smartphone application with or without nicotine replacement therapy in improving smoking cessation among Hispanic adults who would like to quit smoking. The iCanQuit smartphone application focuses on skills for managing urges, motivation, and relapse prevention with personalized quit plans. Nicotine replacement therapy works by giving small, steady doses of nicotine to help stop cravings and relieve symptoms that occur when a person is trying to quit smoking without any of the other harmful chemicals found in tobacco products.
OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants receive access to the iCanQuit smartphone application for 12 months and complete personalized quit plans with education regarding managing urges, motivation, and relapse prevention, on-demand help with tracking of daily cigarette consumption, and monitoring of urges passed without smoking. ARM II: Participants receive access to the iCanQuit smartphone application for 12 months and complete personalized quit plans with education regarding managing urges, motivation, and relapse prevention, on-demand help with tracking of daily cigarette consumption, and monitoring of urges passed without smoking. Participants also receive NRT patch(es) and gum or lozenges to use per the usage instructions tailored to the participants' baseline smoking levels. In addition, participants receive daily push notifications with NRT dosage and refill reminders for 12 months. After completion of study intervention, patients may be followed up at 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
854
Receive access to iCanQuit app, with daily push notifications
Receive nicotine replacement therapy gum
Receive nicotine replacement therapy patch(es)
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
30-day point prevalence abstinence (PPA)
The comparison will use a logistic regression model, following standard intent-to-treat analysis for smoking cessation trials, will be employed, coding all missing outcomes as smoking. The model will adjust for stratification factors and baseline factors that are both imbalanced after randomization and significantly related to the outcome.
Time frame: At 12 months post randomization
30-day PPA
Time frame: At 3 and 6 months post randomization
24 hour PPA
Time frame: At 3, 6 and 12 months post randomization
7 day PPA
Time frame: At 3, 6 and 12 months post randomization
Cost per quitter
Standard methods for estimating cost-effectiveness in smoking cessation interventions will be used. The incremental cost-per-quitter will be estimated as the difference in total cost of delivering the two interventions divided by the difference in the number of 30-day abstinent participants at 12 months.
Time frame: At 12 months post randomization
Cost per life year gained
Standard methods for estimating cost-effectiveness in smoking cessation interventions will be used. To compare iCanQuit with iCanQuit plus NRT in terms of life years gained, researchers will calculate the cost per life year gained.
Time frame: At 12 months post randomization
Cost per quality-adjusted life year (QALY) gained
Standard methods for estimating cost-effectiveness in smoking cessation interventions will be used. Will estimate cost-per-QALY gained.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Receive nicotine replacement therapy lozenge(s)
Ancillary studies
Ancillary studies
Time frame: At 12 months post randomization