iCanQuit Smoking Cessation Among Hispanic Adults

Fred Hutchinson Cancer Center (FHCC)

Status and phase: Not yet enrolling; Phase 3

Conditions: Cigarette Smoking-Related Carcinoma

Treatments: Drug: Nicotine Lozenge; Drug: Nicotine Patch; Device: iCanQuit Smartphone App Smoking Cessation Program; Other: Interview; Other: Survey Administration; Drug: Nicotine Gum

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06811038

NCI-2024-10014 (Registry Identifier)

20697 (Other Identifier)

RG1124868

R01CA298383 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 854 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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854 participants in 2 patient groups

Arm I (iCanQuit application)

Experimental group

Description:

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.

Treatment:

Other: Survey Administration

Other: Interview

Device: iCanQuit Smartphone App Smoking Cessation Program

Arm II (iCanQuit application and NRT)

Experimental group

Description:

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.

Treatment:

Other: Survey Administration

Drug: Nicotine Gum

Other: Interview

Device: iCanQuit Smartphone App Smoking Cessation Program

Drug: Nicotine Patch

Drug: Nicotine Lozenge