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)

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.

Study Overview

• Status: Recruiting
• Conditions: Cigarette Smoking-Related Carcinoma
• Intervention / Treatment: Other: Survey Administration; Procedure: Biospecimen Collection; Behavioral: Smoking Cessation Intervention; Behavioral: Smoking Cessation Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 776
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brie Sullivan; Phone Number: 206-667-5238; Email: bsulliva@fredhutch.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutch/University of Washington Cancer Consortium
      • Contact: Brie Sullivan; Phone Number: 206-667-5238; Email: bsulliva@fredhutch.org
      • Principal Investigator: Jonathan B. Bricker

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm II (NCI QuitGuide app); Participants use the NCI QuitGuide app for at least 45 days on study.	Other: Survey Administration; Ancillary studies; Procedure: Biospecimen Collection; Ancillary studies; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Behavioral: Smoking Cessation Intervention; Use NCI QuitGuide smartphone app; Other Names: Smoking and Tobacco Use Cessation Interventions; Behavioral: Smoking Cessation Intervention; Use IndigeQuit smartphone app; Other Names: Smoking and Tobacco Use Cessation Interventions
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.	Other: Survey Administration; Ancillary studies; Procedure: Biospecimen Collection; Ancillary studies; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Behavioral: Smoking Cessation Intervention; Use NCI QuitGuide smartphone app; Other Names: Smoking and Tobacco Use Cessation Interventions; Behavioral: Smoking Cessation Intervention; Use IndigeQuit smartphone app; Other Names: Smoking and Tobacco Use Cessation Interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day 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 3- and 6-months post randomization
Self-reported 24-hour PPA	A secondary definition of cessation will include self-reported abstinence from cigarettes and all other commercial nicotine-containing tobacco products (i.e., e-cigarettes or vaping, chewing tobacco, snus, hookahs, cigars, cigarillos, tobacco pipes, kreteks). 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 the 3, 6, and 12-month follow-ups
Self-reported 7-day PPA	A secondary definition of cessation will include self-reported abstinence from cigarettes and all other commercial nicotine-containing tobacco products (i.e., e-cigarettes or vaping, chewing tobacco, snus, hookahs, cigars, cigarillos, tobacco pipes, kreteks). 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 the 3, 6, and 12-month follow-ups

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jonathan B. Bricker, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: November 17, 2023
• First Submitted That Met QC Criteria: November 17, 2023
• First Posted (Actual): November 24, 2023

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Manufactured Materials; Technology, Industry, and Agriculture; Specimen Handling; Smoking Devices
• Other Study ID Numbers: RG1123796 (Fred Hutch/University of Washington Cancer Consortium); NCI-2023-09049 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R01CA284687 (U.S. NIH Grant/Contract); 20279 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes