Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06145763

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

Led by Fred Hutchinson Cancer Center ยท Updated on 2026-02-09

776

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

F

Fred Hutchinson Cancer Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a new smartphone app called IndigeQuit to help American Indians and Alaska Natives (AI/ANs) quit smoking, comparing it to the existing National Cancer Institute (NCI) QuitGuide app. AI/ANs face much higher rates of smoking-related cancers and deaths compared to other groups, often due to limited access to effective cessation interventions. This trial aims to test whether the IndigeQuit app, designed to teach skills for coping with urges and preventing relapse, is more effective in supporting smoking cessation for this population. Participants are randomly assigned to one of two groups: one uses the IndigeQuit app, which involves creating a personalized quit plan, completing eight content levels, accessing on-demand help, and tracking daily smoking for at least 45 days; the other group uses the NCI QuitGuide app for at least the same duration. After completing the intervention period, participants are followed up at 3, 6, and 12 months to assess ongoing smoking status and app effects. During the study, participants provide information through surveys and may contribute biospecimens for ancillary studies. Researchers measure smoking abstinence rates, focusing on 30-day abstinence at 12 months as the primary outcome, with additional assessments at earlier intervals. The study lasts over a year with multiple follow-up points, ensuring detailed monitoring of smoking behavior changes and app engagement.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Self-identify as American Indian or Alaska Native, alone or with other races
  • Age 18 years or older
  • Smoked cigarettes daily for the past year
  • Interested in quitting smoking within the next 30 days
  • Willing to be randomly assigned to either app group
  • Have daily access to own Android or iPhone
  • Able to download a smartphone app
  • Willing and able to read English
  • Not currently or within past 30 days using other smoking cessation behavioral or pharmacological interventions
  • Never participated in prior related research
  • No other household or family member participating
  • Willing to complete follow-up assessments at 3, 6, and 12 months
  • Provide email, phone number(s), and mailing address
  • Live off US AI/AN tribal reservations or on approved Northern Plains tribal reservations
Not Eligible

You will not qualify if you...

  • Currently (within past 30 days) using other smoking cessation behavioral interventions
  • Has participated in prior related research trials
  • Has used the NCI QuitGuide app before
  • Not willing to complete follow-up surveys at 3, 6, and 12 months
  • Not providing email, phone number(s), and mailing address

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

screening and enrollment visit

Outpatient Treatment

Duration - At least 45 days

Participants use either the IndigeQuit app or the NCI QuitGuide app to support smoking cessation. They follow a personalized quit plan, use app content, and track smoking behaviors for at least 45 days.

1 baseline visit and regular app use

Follow-up

Duration - Up to 12 months post intervention start

Participants complete follow-up assessments to report smoking status at 3, 6, and 12 months after starting the intervention.

3 follow-up visits at 3, 6, and 12 months

Trial Site Locations

Total: 1 location

1

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States, 98109

Actively Recruiting

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Research Team

B

Brie Sullivan

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Development of a Culturally Adapted Smartphone App (IndigeQuit) Designed to Help American Indian and Alaska Native People Quit Commercial Cigarettes: User-Centered Mixed Methods Study.

Jonathan B Bricker, Margarita Santiago-Torres, Brianna M Sullivan...

https://pubmed.ncbi.nlm.nih.gov/41875428