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

NCT06145763 | Recruiting FDA Device

• 4 other identifiers: RG1123796NCI-2023-0904920279R01CA284687
• Study Type: interventional
• Target: 776
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cigarette Smoking-Related Carcinoma

Outcome Measures

Primary Outcomes (1)

• 30-day point prevalence abstinence (PPA)

  Will be assessed based on self-report with biochemical verification of salivary cotinine. For each comparison of treatment arms on cessation outcomes, will use a logistic regression model.

  At 12 months post randomization

Secondary Outcomes (3)

• 30-day PPA

  At 3- and 6-months post randomization

• Self-reported 24-hour PPA

  At the 3, 6, and 12-month follow-ups

• Self-reported 7-day PPA

  At the 3, 6, and 12-month follow-ups

Study Arms (2)

Arm I (IndigeQuit app)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Behavioral: Smoking Cessation Intervention; Other: Survey Administration

Arm II (NCI QuitGuide app)

ACTIVE COMPARATOR

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

Procedure: Biospecimen Collection; Behavioral: Smoking Cessation Intervention; Other: Survey Administration

Interventions

Biospecimen Collection PROCEDURE

Ancillary studies

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (IndigeQuit app); Arm II (NCI QuitGuide app)

Smoking Cessation Intervention BEHAVIORAL

Use IndigeQuit smartphone app

Also known as: Smoking and Tobacco Use Cessation Interventions

Arm I (IndigeQuit app)

Survey Administration OTHER

Ancillary studies

Arm I (IndigeQuit app); Arm II (NCI QuitGuide app)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

RECRUITING

Related Publications (1)

• 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 Study. JMIR Form Res. 2026 Mar 24;10:e88768. doi: 10.2196/88768.

  PMID: 41875428 DERIVED

MeSH Terms

Interventions

Specimen Handling; Smoking Devices

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Jonathan B. Bricker

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brie Sullivan

CONTACT

206-667-5238; bsulliva@fredhutch.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Random assignments will be concealed from participants and research staff throughout the trial.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 24, 2023
• Study Start: July 3, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2028
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)