iCanQuit Smoking Cessation Among Hispanic Adults

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.

• iCanQuit Smartphone App Smoking Cessation Program (Device), also known as iCanQuit: Receive access to iCanQuit app, with daily push notifications
• Nicotine Gum (Drug), also known as Nicorette, Nicotine Polacrilex gum: Receive nicotine replacement therapy gum
• Nicotine Patch (Drug), also known as NicoDerm CQ, Nicotine Skin Patch, Nicotine Transdermal Patch: Receive nicotine replacement therapy patch(es)
• Nicotine Lozenge (Drug), also known as Nicorette, mini lozenge, Nicotine Polacrilex lozenge: Receive nicotine replacement therapy lozenge(s)
• Survey Administration (Other): Ancillary studies
• Interview (Other): Ancillary studies

Primary outcomes

• 30-day point prevalence abstinence (PPA) [At 12 months post randomization]: 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.

Secondary outcomes

• 30-day PPA [At 3 and 6 months post randomization]
• 24 hour PPA [At 3, 6 and 12 months post randomization]
• 7 day PPA [At 3, 6 and 12 months post randomization]
• Cost per quitter [At 12 months post randomization]: 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.
• Cost per life year gained [At 12 months post randomization]: 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.
• Cost per quality-adjusted life year (QALY) gained [At 12 months post randomization]: Standard methods for estimating cost-effectiveness in smoking cessation interventions will be used. Will estimate cost-per-QALY gained.

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* Self-identify as Hispanic ethnicity
* Age 18 and older
* Smoking at least one cigarette per day in the past 30 days
* Want to quit smoking within 30 days
* Interest in learning skills to quit smoking
* Willing to be randomly assigned
* United States (US) or Puerto Rico (PR) residency for the next twelve months
* Have daily access to their own Android or iPhone smartphone
* Ability to download a smartphone application (app)
* Proficiency in English or Spanish
* Not currently (i.e., within past 30 days) using other smoking cessation interventions
* Willing to consider using NRT
* No previous use of iCanQuit
* No household or family member participating
* Willingness to complete follow-up assessments at the 3-, 6-, and 12-month follow-ups
* Providing email, phone number(s), and mailing address

Exclusion Criteria:

* NRT CONTRAINDICATION: Heart attack in the last 2 months
* NRT CONTRAINDICATION: Stroke in the last 6 months
* NRT CONTRAINDICATION: Diagnosed arrhythmia or tachycardia
* NRT CONTRAINDICATION: Uncontrolled hypertension
* NRT CONTRAINDICATION: Currently using warfarin
* NRT CONTRAINDICATION: Pregnant or breastfeeding, or plans to become pregnant during the next 6 months

• Jonathan Bricker, PhD, Principal investigator, Fred Hutch/University of Washington Cancer Consortium

NIH grants: R01CA298383