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Not yet recruiting NCT06811038

iCanQuit Smoking Cessation Among Hispanic Adults

Phase III Interventional Cigarette Smoking-Related Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: iCanQuit Smartphone App Smoking Cessation Program, Nicotine Gum, Nicotine Patch, Nicotine Lozenge.
Who it may be relevant to
Registry conditions: Cigarette Smoking-Related Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Providing Nicotine Replacement Therapy to Enhance the Efficacy of a Smoking Cessation Smartphone App for Hispanic Adults

Overview

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.

Interventions

  • Device iCanQuit Smartphone App Smoking Cessation Program
    Receive access to iCanQuit app, with daily push notifications
  • Drug Nicotine Gum
    Receive nicotine replacement therapy gum
  • Drug Nicotine Patch
    Receive nicotine replacement therapy patch(es)
  • Drug Nicotine Lozenge
    Receive nicotine replacement therapy lozenge(s)
  • Other Survey Administration
    Ancillary studies
  • Other Interview
    Ancillary studies

Primary outcome measures

  • 30-day point prevalence abstinence (PPA) [Time frame: At 12 months post randomization]
Secondary outcome measures (6)
  • 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 [Time frame: At 12 months post randomization]
  • Cost per life year gained [Time frame: At 12 months post randomization]
  • Cost per quality-adjusted life year (QALY) gained [Time frame: At 12 months post randomization]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Fred Hutch/University of Washington Cancer Consortium — Seattle

Identifiers

NCT: NCT06811038 · RG1124868 · NCI-2024-10014 · 20697 · R01CA298383

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗