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Набор скоро начнётся NCT06811038

iCanQuit Smoking Cessation Among Hispanic Adults

Фаза III С лечением Cigarette Smoking-Related Carcinoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: iCanQuit Smartphone App Smoking Cessation Program, Nicotine Gum, Nicotine Patch, Nicotine Lozenge.
Кому может быть актуально
Состояния в реестре: Cigarette Smoking-Related Carcinoma. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • 30-day point prevalence abstinence (PPA) [Срок оценки: At 12 months post randomization]
Вторичные конечные точки (6)
  • 30-day PPA [Срок оценки: At 3 and 6 months post randomization]
  • 24 hour PPA [Срок оценки: At 3, 6 and 12 months post randomization]
  • 7 day PPA [Срок оценки: At 3, 6 and 12 months post randomization]
  • Cost per quitter [Срок оценки: At 12 months post randomization]
  • Cost per life year gained [Срок оценки: At 12 months post randomization]
  • Cost per quality-adjusted life year (QALY) gained [Срок оценки: At 12 months post randomization]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Fred Hutch/University of Washington Cancer Consortium — Seattle

Идентификаторы

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

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗