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

Part of paid clinical trials in Seattle, Washington.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT06145763
Status
Recruiting
Apply to this trial

Conditions

  • Cigarette Smoking-Related Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Ancillary studies
  • Smoking Cessation Intervention — BEHAVIORAL
    Use IndigeQuit smartphone app
  • Smoking Cessation Intervention — BEHAVIORAL
    Use NCI QuitGuide smartphone app
  • Survey Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Jul 3, 2025
Status verified
Feb 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2028

Study Design

Enrollment
776 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Arm I (IndigeQuit app)
    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.
  • Active Comparator: Arm II (NCI QuitGuide app)
    Participants use the NCI QuitGuide app for at least 45 days on study.

Primary Outcome Measure

30-day point prevalence abstinence (PPA) [ Time Frame: At 12 months post randomization ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Brie Sullivan
[email protected]
206-667-5238
Jonathan B. Bricker (PRINCIPAL_INVESTIGATOR)

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By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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