Clinical trial NCT06811038: iCanQuit Smoking Cessation Among Hispanic Adults
Official title: Providing Nicotine Replacement Therapy to Enhance the Efficacy of a Smoking Cessation Smartphone App for Hispanic Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Cigarette Smoking-Related Carcinoma
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2025-02-06
Enrollment: 854
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: 30-day point prevalence abstinence (PPA)
timeFrame: At 12 months post randomization
Secondary outcomes:
measure: 30-day PPA
timeFrame: At 3 and 6 months post randomization
measure: 24 hour PPA
timeFrame: At 3, 6 and 12 months post randomization
measure: 7 day PPA
timeFrame: At 3, 6 and 12 months post randomization
measure: Cost per quitter
timeFrame: At 12 months post randomization
measure: Cost per life year gained
timeFrame: At 12 months post randomization
measure: Cost per quality-adjusted life year (QALY) gained
timeFrame: At 12 months post randomization
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Jonathan Bricker, PhD
role: PRINCIPAL_INVESTIGATOR
References: