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Набор скоро начнётся NCT06697496

A Smartphone Application (QuitBot) for the Improvement of Smoking Cessation Among American Indians and Alaska Natives, NAITIVE Trial

Без фазы 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: QuitBot Smoking Cessation Chatbot Program, QuitBot Smoking Cessation Text Messaging Program, Survey Administration, Interview.
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

Navigation and Artificial Intelligence Technology for Indigenous Virtual Education on Smoking Cessation (NAITIVE)

Обзор

This clinical trial develops a chatbot smartphone application (app), QuitBot, and text messaging to help American Indians (AI) and Alaska Natives (AN) to quit smoking commercial tobacco (smoking cessation), and evaluates two remote smoking cessation programs to see how well they work for helping AI/AN people quit smoking commercial tobacco. AI/AN populations have one of the highest rates of commercial cigarette smoking of any racial and ethnic group in the United States (US). They also have a higher rate of developing smoking-related cancer but are less likely to quit smoking. The two programs are designed to provide personalized support in setting a smoking cessation goal, tasks to reach the smoking cessation goal, and motivation to remain smoke-free. This may help to keep participants engaged and support them in their quit efforts, and may improve smoking cessation among AI and AN.

Подробное описание

OUTLINE: Participants are randomized to 1 of 2 arms. Both groups receive access to a 42-day quit smoking program.

ARM I: Participants receive daily QuitBot program chatbot messages about the importance of quitting smoking, setting a quit date, preparing to quit, quitting, and maintaining abstinence over 42 days.

ARM II: Participants receive daily QuitBot text messages about the importance of quitting smoking, setting a quit date, preparing to quit, quitting, and maintaining abstinence over 42 days.

After completion of study intervention, participants are followed up at 3, 6, and 12 months and may be contacted thereafter for up to 24 months.

Вмешательства

  • Устройство QuitBot Smoking Cessation Chatbot Program
    Participate in Quitbot chatbot program
  • Устройство QuitBot Smoking Cessation Text Messaging Program
    Participate in Quitbot texting program
  • Другое Survey Administration
    Ancillary studies
  • Другое Interview
    Ancillary studies
  • Процедура Carbon Monoxide Measurement
    Ancillary studies

Первичные конечные точки

  • 30-day point prevalence abstinence (PPA) [Срок оценки: At 12-months post-randomization]
Вторичные конечные точки (5)
  • 30-day PPA [Срок оценки: At 3- and 6- months post-randomization]
  • Measures of bond between user and conversational chatbot [Срок оценки: At 3- and 6-months post-randomization]
  • Agreement on goals of treatment [Срок оценки: At 3- and 6-months post-randomization]
  • Agreement on tasks of treatment [Срок оценки: At 3- and 6-months post-randomization]
  • User's sense that QuitBot understands their needs [Срок оценки: At 3- and 6-months post-randomization]

Критерии участия

Критерии включения

  • Self-identifying as American Indian or Alaska Native, either alone or in combination with other races
  • Age 18 and older
  • Smoking combustible cigarettes daily in the past year
  • Interest in quitting smoking
  • Interest in learning skills to quit smoking
  • Willing to be randomly assigned
  • Have daily access to their own Android or iPhone smartphone
  • Ability to download a smartphone app
  • Ability to read English
  • Not currently (i.e., within past 30 days) using other smoking cessation interventions
  • No prior participation in our studies
  • No prior use of SFT
  • No household or family member participating
  • US residency for the next twelve months
  • 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

  • The reverse of the inclusion criteria
  • Pregnant or breastfeeding
  • Use of other tobacco products (e.g., ceremonial use of tobacco, e-cigarettes) will be assessed but is not an exclusion criterion, as it would limit the study's generalizability

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
Тройное слепое
Основная цель
Профилактика

Центры проведения

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

Идентификаторы

NCT: NCT06697496 · RG1124884 · NCI-2024-08892 · U19MD020533 · FHIRB0020651

Первоисточники (государственные реестры)

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