Cigarette Smoking-Related CarcinomaNCT06145763
A Digital Smoking Cessation Intervention for Helping American Indians and Alaska Natives Quit Smoking, IndigeQuit Trial
A study testing Biospecimen Collection, Smoking Cessation Intervention and Survey Administration in people with Cigarette Smoking-Related Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking-Related Carcinoma
- What is being tested?
- Biospecimen Collection, Smoking Cessation Intervention and Survey Administration
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 776 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2025to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Brie Sullivan, 206-667-5238, bsulliva@fredhutch.org
Jonathan B. Bricker
About this study
Official title: 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.
Read the 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.
- Conditions
- Cigarette Smoking-Related Carcinoma
- Being tested
- Biospecimen Collection, Smoking Cessation Intervention, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Ancillary studies
Smoking Cessation InterventionBehavioural
Also called Smoking and Tobacco Use Cessation Interventions
Use IndigeQuit smartphone app
Smoking Cessation InterventionBehavioural
Also called Smoking and Tobacco Use Cessation Interventions
Use NCI QuitGuide smartphone app
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Biospecimen Collection; Behavioral: Smoking Cessation Intervention; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 12 months post randomization
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: At the 3, 6, and 12-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start3 Jul 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cigarette Smoking-Related CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 776 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jonathan B. Bricker, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145763
- Sponsor's protocol ID
- RG1123796
- Other IDs
- NCI-2023-09049, 20279, R01CA284687
- Status last verified
- Aug 2026
- First submitted
- 17 Nov 2023
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bricker JB, Santiago-Torres M, Sullivan BM, Mull KE, Clark HW, Kornacki C, Afraid Of Lightning-Craddock T, Seneca DS, Stanford CM, Wilcox SL, Henderson PN, Nelson L. A Culturally Adapted Smoking Cessation App (IndigeQuit) for American Indian and Alaska Native Adults: Protocol for a Randomized Clinical Trial. JMIR Res Protoc. 2026 Sep 2;15:e102675. doi: 10.2196/102675.
PubMed 42686173Bricker 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.
PubMed 41875428
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Smoking Cessation Intervention for Nationally-Recruited American Indians and Alaska Natives: A Full-Scale Randomized Controlled Trial (IndigeQuit)
- ClinicalTrials.gov ID
- NCT06145763
- Acronym / sponsor ID
- RG1123796
- Conditions
- Cigarette Smoking-Related Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 776 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (IndigeQuit app) | Experimental | Procedure: Biospecimen Collection, Behavioral: Smoking Cessation Intervention, Other: Survey AdministrationParticipants 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 (NCI QuitGuide app) | Active comparator | Procedure: Biospecimen Collection, Behavioral: Smoking Cessation Intervention, Other: Survey AdministrationParticipants use the NCI QuitGuide app for at least 45 days on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionAncillary studies | Procedure or surgery | Arm I (IndigeQuit app), Arm II (NCI QuitGuide app) |
| Smoking Cessation InterventionAlso: Smoking and Tobacco Use Cessation InterventionsUse IndigeQuit smartphone app | Behavioural | Arm I (IndigeQuit app) |
| Smoking Cessation InterventionAlso: Smoking and Tobacco Use Cessation InterventionsUse NCI QuitGuide smartphone app | Behavioural | Arm II (NCI QuitGuide app) |
| Survey AdministrationAncillary studies | Other | Arm I (IndigeQuit app), Arm II (NCI QuitGuide app) |
Primary outcome
30-day point prevalence abstinence (PPA)
Time frame: At 12 months post randomization
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.
3 secondary outcomes
30-day PPA
Time frame: At 3- and 6-months post randomization
Self-reported 24-hour PPA
Time frame: At the 3, 6, and 12-month follow-ups
Self-reported 7-day PPA
Time frame: At the 3, 6, and 12-month follow-ups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Derived from this study: PubMed 42686173Bricker JB, Santiago-Torres M, Sullivan BM, Mull KE, Clark HW, Kornacki C, Afraid Of Lightning-Craddock T, Seneca DS, Stanford CM, Wilcox SL, Henderson PN, Nelson L. A Culturally Adapted Smoking Cessation App (IndigeQuit) for American Indian and Alaska Native Adults: Protocol for a Randomized Clinical Trial. JMIR Res Protoc. 2026 Sep 2;15:e102675. doi: 10.2196/102675.
- Derived from this study: PubMed 41875428Bricker 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan B. Bricker principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biospecimen Collection, Smoking Cessation Intervention and Survey Administration in people with Cigarette Smoking-Related Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brie Sullivan (206-667-5238, bsulliva@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day point prevalence abstinence (PPA) (time frame: At 12 months post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06145763, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.