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Набор скоро начнётся NCT07739706

A Novel Smartphone Application for Helping Teens Stop Vaping, QuitQuest Vaping R01

Без фазы С лечением Tobacco-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: Smartphone Application-based Intervention, Smartphone Application-based Intervention, Survey Administration, Interview.
Кому может быть актуально
Состояния в реестре: Tobacco-Related Carcinoma. Базовые параметры: 13 лет — 17 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

QuitQuest: Full Scale Randomized Trial of a Novel Smartphone Application to Help Teens Stop Vaping (QuitQuest Vaping R01)

Обзор

This clinical trial compares a novel smartphone application (app) called QuitQuest to the National Cancer Institute's (NCI's) SmokefreeTeenQuitVaping (SFTQV) app in helping teens stop vaping. Despite recent declines, data shows that 8.5% of middle school (grades 6-8) and 18.1% of high school (grades 9-12) students in the United States (US) used electronic nicotine delivery systems (ENDS; variously known as vaping, electronic \[e\]-cigarettes, e-cigs, mods, and tank systems that contain nicotine). Use of any tobacco product during adolescence increases risk for lifelong nicotine addiction. ENDS use, in particular, leads to severe asthma attacks, e-cigarette or vaping product use-associated lung injury (EVALI), exposure to multiple lung irritants, including volatile organic compounds, and lasting harm to adolescent brain development. Despite evidence of potential long-term harms from ENDS, to date there have been limited evidence-based therapeutic options for ENDS cessation for adolescents and young adults. Traditional methods for delivering adolescent ENDS cessation interventions (e.g., quitlines and clinics) have limited reach. QuitQuest utilizes Acceptance and Commitment Therapy (ACT), a psychological intervention that uses acceptance and mindfulness strategies, together with commitment and behavior change strategies, to increase psychological flexibility, reduce distress, and promote behavior change through mechanisms that include cultivating acceptance of internal experience and aligning behavior with personal values. The SFTQV program is based on the US Clinical Practice Guidelines, offering practical advice and support via an app delivery format. The QuitQuest app may work better than the SFTQV app in increasing vape quit rates among teens.

Подробное описание

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants download and install the QuitQuest app for 12 months on study.

ARM II: Participants utilize the National Cancer Institute's (NCI's) SFTQV app for 12 months on study.

Вмешательства

  • Поведенческое Smartphone Application-based Intervention
    Use QuitQuest app
  • Поведенческое Smartphone Application-based Intervention
    Use SFTQV app
  • Другое Survey Administration
    Ancillary studies
  • Другое Interview
    Ancillary studies

Первичные конечные точки

  • Self-reported 30-day point prevalence abstinence (PPA) from electronic nicotine delivery systems (ENDS) use [Срок оценки: At 6 months post-randomization]
Вторичные конечные точки (5)
  • Self-reported 30-day PPA from ENDS use [Срок оценки: At 3 and 12 months post-randomization]
  • Self-reported 24-hour PPA from ENDS use [Срок оценки: At 3, 6, and 12 months post-randomization]
  • Self-reported 7-day PPA from ENDS use [Срок оценки: At 3, 6, and 12 months post-randomization]
  • Self-reported 30-day PPA from ENDS use [Срок оценки: At 3, 6, and 12 months post-randomization]
  • Biochemical verification of self-reported abstinence among participants who opt in at baseline and complete testing [Срок оценки: Up to 12 months post-randomization]

Критерии участия

Критерии включения

  • Age 13 to 17
  • Used ENDS at least weekly in the past 30 days
  • Wants to quit ENDS within the next 30 days
  • If concurrently using any other nicotine or tobacco products, wants to quit using them within the next 30 days
  • Interest in learning skills to quit ENDS
  • Willing to be randomly assigned to either condition
  • Resides in the United States (US) for the next 12 months
  • Has daily access to their own smartphone
  • Ability to download a smartphone app
  • Able to read in English
  • Not using other ENDS cessation interventions
  • Have not participated in our prior studies
  • No household or family member participating
  • Willingness to complete survey and biochemical assessments at 3, 6, and 12 months
  • Providing phone number(s), email, and mailing address

Критерии исключения

  • Exclusion criteria are the reverse of the inclusion criteria

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
Простое слепое
Основная цель
Профилактика

Центры проведения

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

Идентификаторы

NCT: NCT07739706 · RG1126381 · NCI-2026-04135 · FHIRB0021244

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗