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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-09049 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 20279 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| R01CA284687 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Arm II (NCI QuitGuide app) | Active Comparator | Participants use the NCI QuitGuide app for at least 45 days on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Ancillary studies |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brie Sullivan | Contact | 206-667-5238 | bsulliva@fredhutch.org |
| Name | Affiliation | Role |
|---|---|---|
| Jonathan B. Bricker | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Recruiting | Seattle | Washington | 98109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41875428 | Derived | 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. |
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Random assignments will be concealed from participants and research staff throughout the trial.
| Smoking Cessation Intervention | Behavioral | Use IndigeQuit smartphone app |
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| Smoking Cessation Intervention | Behavioral | Use NCI QuitGuide smartphone app |
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| Survey Administration | Other | Ancillary studies |
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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 |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D000074602 | Smoking Devices |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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