iCanQuit Smoking Cessation Among Hispanic Adults

Phase 3

Not yet recruiting

• Conditions: Cigarette Smoking-Related Carcinoma
• Interventions: Device: iCanQuit Smartphone App Smoking Cessation Program; Other: Survey Administration; Drug: Nicotine Gum; Other: Interview; Drug: Nicotine Patch; Drug: Nicotine Lozenge

• Registration Number: NCT06811038
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief Summary

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.

Detailed Description

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 Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-31
• Study First Submitted QC: 2025-01-31
• Study First Posted: 2025-02-06
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-19
• Study Start: 2025-06-01
• Primary Completion: 2029-07-01
• Study Completion: 2030-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 854

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (iCanQuit application)	iCanQuit Smartphone App Smoking Cessation Program	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 I (iCanQuit application)	Survey Administration	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 I (iCanQuit application)	Interview	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 (iCanQuit application and NRT)	iCanQuit Smartphone App Smoking Cessation Program	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 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.
Arm II (iCanQuit application and NRT)	Nicotine Gum	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 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.
Arm II (iCanQuit application and NRT)	Nicotine Patch	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 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.
Arm II (iCanQuit application and NRT)	Nicotine Lozenge	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 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.
Arm II (iCanQuit application and NRT)	Survey Administration	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 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.
Arm II (iCanQuit application and NRT)	Interview	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 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States