NCT06145763

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 776 (estimated)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Cigarette Smoking-Related Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Ancillary studies
BEHAVIORAL	Smoking Cessation Intervention	Use IndigeQuit smartphone app
BEHAVIORAL	Smoking Cessation Intervention	Use NCI QuitGuide smartphone app
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2025-07-03
• Primary completion: 2027-11-30
• Completion: 2028-11-30
• First posted: 2023-11-24
• Last updated: 2026-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study