A Digital Smoking Cessation Intervention for Helping American Indians and Alaska Natives Quit Smoking, IndigeQuit Trial

Официальное название

Digital Smoking Cessation Intervention for Nationally-Recruited American Indians and Alaska Natives: A Full-Scale Randomized Controlled Trial (IndigeQuit)

Обзор

This clinical trial compares a new smoking cessation smartphone application (app) (IndigeQuit) to an existing smarphone app (National Cancer Institute \[NCI\] QuitGuide) for helping American Indians and Alaska Natives (AI/ANs) quit smoking. Compared to other racial/ethnic groups, AIANs have 6 times higher rates of developing smoking-related cancers, including lung cancer. Commercial cigarette smoking accounts for half of all deaths among AIANs nationwide. AIANs' often lack of access to smoking cessation interventions, which may be due to inequities in the healthcare system, lack of health insurance, living in rural areas, systemic racism, and historical trauma. There is also a lack of effective smoking cessation interventions for AIANs. Smartphone apps have the potential to deliver a low-cost smoking cessation intervention with wide reach to AIANs. Apps require no in-person delivery and no provider training, do not require integration into complex hospital systems, can be freely accessed on an app store, and are available at any time and any place. IndigeQuit is a behavioral intervention designed to help adults stop smoking by teaching skills for coping with smoking urges, staying motivated, and preventing relapse. The IndigeQuit app intervention may be more effective than the currently available NCI QuitGuide app at helping AIANs quit smoking.

Подробное описание

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants use the IndigeQuit app, which includes setting up a personalized quit plan, participating in eight levels of the content, receiving on-demand help in coping with smoking urges, and tracking their daily smoking behaviors for at least 45 days on study.

ARM II: Participants use the NCI QuitGuide app for at least 45 days on study.

After completion of study intervention, patients are followed up at 3, 6, and 12-months.

Вмешательства

• Процедура Biospecimen Collection
  Ancillary studies
• Поведенческое Smoking Cessation Intervention
  Use IndigeQuit smartphone app
• Поведенческое Smoking Cessation Intervention
  Use NCI QuitGuide smartphone app
• Другое Survey Administration
  Ancillary studies

Первичные конечные точки

• 30-day point prevalence abstinence (PPA) [Срок оценки: At 12 months post randomization]

Вторичные конечные точки (3)

• 30-day PPA [Срок оценки: At 3- and 6-months post randomization]
• Self-reported 24-hour PPA [Срок оценки: At the 3, 6, and 12-month follow-ups]
• Self-reported 7-day PPA [Срок оценки: At the 3, 6, and 12-month follow-ups]

Критерии участия

Критерии включения

• Self-identify as American Indian or Alaska Native, either alone or in combination with other races
• Age 18 and older
• Has smoked daily for the past year
• Interest in quitting smoking within the next 30 days
• Willing to be randomly assigned to either app
• Have daily access to their own Android or iPhone
• Able to download a smartphone app
• Be willing and able to read English
• Not currently or within past 30 days using other smoking cessation behavioral interventions or smoking cessation pharmacotherapies
• Have never participated in our prior research
• Have no other household or family member participating
• Being willing to complete the 3, 6, and 12-month follow-up assessments
• Providing email, phone number(s), and mailing address
• Living off United States (US) AI/AN tribal reservations or living on five Northern Plains tribal reservations from whom we would obtain approvals to recruit

Критерии исключения

• Currently (i.e., within past 30 days) using other smoking cessation behavioral interventions
• Has participated in our prior research trials
• Has used the National Cancer Institute's (NCI's) QuitGuide app
• Not willing to complete a follow-up survey at 3, 6, and 12 months post-randomization
• Not providing email, phone number(s), and mailing address

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

Публикации

• Bricker JB, Santiago-Torres M, Sullivan BM, Mull KE, Clark HW, Fogel CA, Hwang SB, Keith AR, Kornacki C, Afraid Of Lightning-Craddock T, Martinez SA, Seneca DS, Stanford CM, Terry C, Wilcox SL, Nelson L, Henderson PN. Development of a Culturally Adapted Smartphone App (IndigeQuit) Designed to Help American Indian and Alaska Native People Quit Commercial Cigarettes: User-Centered Mixed Methods Stud PMID 41875428

Идентификаторы

NCT: NCT06145763 · RG1123796 · NCI-2023-09049 · 20279 · R01CA284687

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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