Cigarette Smoking-Related CarcinomaNCT06697496
A Smartphone Application (QuitBot) for the Improvement of Smoking Cessation Among American Indians and Alaska Natives, NAITIVE Trial
A study testing QuitBot Smoking Cessation Chatbot Program, QuitBot Smoking Cessation Text Messaging Program 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 develops a chatbot smartphone application (app), QuitBot, and text messaging to help American Indians (AI) and Alaska Natives (AN) to quit smoking commercial tobacco (smoking cessation), and evaluates two remote smoking cessation programs to see how well they work for helping AI/AN people quit… 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?
- QuitBot Smoking Cessation Chatbot Program, QuitBot Smoking Cessation Text Messaging Program and Survey Administration
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 772 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2026to 31 Oct 2030
- 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-identifying as American Indian or Alaska Native, either alone or in combination with other races
- Age 18 and older
- Smoking combustible cigarettes daily in the past year
- Interest in quitting smoking
- Interest in learning skills to quit smoking
- Willing to be randomly assigned
Show all 16Show fewer
- Have daily access to their own Android or iPhone smartphone
- Ability to download a smartphone app
- Ability to read English
- Not currently (i.e., within past 30 days) using other smoking cessation interventions
- No prior participation in our studies
- No prior use of SFT
- No household or family member participating
- US residency for the next twelve months
- Willingness to complete follow-up assessments at the 3-, 6-, and 12-month follow-ups
- Providing email, phone number(s), and mailing address
Who cannot join
- The reverse of the inclusion criteria
- Pregnant or breastfeeding
- Use of other tobacco products (e.g., ceremonial use of tobacco, e-cigarettes) will be assessed but is not an exclusion criterion, as it would limit the study's generalizability
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
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Jonathan Bricker, PhD, 206-667-5074, jbricker@fredhutch.org
Jonathan Bricker, PhD
About this study
Official title: Navigation and Artificial Intelligence Technology for Indigenous Virtual Education on Smoking Cessation (NAITIVE)
This clinical trial develops a chatbot smartphone application (app), QuitBot, and text messaging to help American Indians (AI) and Alaska Natives (AN) to quit smoking commercial tobacco (smoking cessation), and evaluates two remote smoking cessation programs to see how well they work for helping AI/AN people quit smoking commercial tobacco. AI/AN populations have one of the highest rates of commercial cigarette smoking of any racial and ethnic group in the United States (US). They also have a higher rate of developing smoking-related cancer but are less likely to quit smoking. The two programs are designed to provide personalized support in setting a smoking cessation goal, tasks to reach the smoking cessation goal, and motivation to remain smoke-free. This may help to keep participants engaged and support them in their quit efforts, and may improve smoking cessation among AI and AN.
Read the detailed description
OUTLINE: Participants are randomized to 1 of 2 arms. Both groups receive access to a 42-day quit smoking program.
ARM I: Participants receive daily QuitBot program chatbot messages about the importance of quitting smoking, setting a quit date, preparing to quit, quitting, and maintaining abstinence over 42 days.
ARM II: Participants receive daily QuitBot text messages about the importance of quitting smoking, setting a quit date, preparing to quit, quitting, and maintaining abstinence over 42 days.
After completion of study intervention, participants are followed up at 3, 6, and 12 months and may be contacted thereafter for up to 24 months.
- Conditions
- Cigarette Smoking-Related Carcinoma
- Being tested
- QuitBot Smoking Cessation Chatbot Program, QuitBot Smoking Cessation Text Messaging Program, Survey Administration, Interview, Carbon Monoxide Measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuitBot Smoking Cessation Chatbot ProgramDevice
Also called QuitBot chatbot program
Participate in Quitbot chatbot program
QuitBot Smoking Cessation Text Messaging ProgramDevice
Also called QuitBot texting program
Participate in Quitbot texting program
Survey AdministrationOther
Ancillary studies
InterviewOther
Ancillary studies
Carbon Monoxide MeasurementProcedure or surgery
Also called CMONOX
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (QuitBot chatbot) | Experimental | Participants participate in the QuitBot program which involves chatbot messages over 42 days. Therapy description withheld to protect the integrity of the study. Receives: Device: QuitBot Smoking Cessation Chatbot Program; Other: Survey Administration; Other: Interview; Procedure: Carbon Monoxide Measurement |
| Arm II (QuitBot texting) | Active comparator | Participants participate in the QuitBot program which involves text messages over 42 days. Therapy description withheld to protect the integrity of the study. Receives: Device: QuitBot Smoking Cessation Text Messaging Program; Other: Survey Administration; Procedure: Carbon Monoxide Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day point prevalence abstinence (PPA)
Will use a logistic regression model and standard smoking cessation trial intent-to-treat analysis, with all missing outcomes will be coded as smoking. The model will adjust for stratification factors and baseline factors that are significantly related to the outcome. Sensitivity analyses will include: (1) multiple imputation of missing outcomes, (2) complete case analysis, and (3) carbon monoxide (CO)-verified results adjusted for use of other combustible nicotine-containing tobacco products at the 12-month follow-up-in order to differentiate them from use of cigarettes at 12 months.
Measured: At 12-months post-randomization
Secondary outcomes (5)
30-day PPA
Also 24-hour and 7-day PPA at the 3-, 6-, and 12- month follow-ups. Will use a logistic regression model and standard smoking cessation trial intent-to-treat analysis, with all missing outcomes will be coded as smoking. The model will adjust for stratification factors and baseline factors that are significantly related to the outcome. Sensitivity analyses will include: (1) multiple imputation of missing outcomes, (2) complete case analysis, and (3) CO-verified results adjusted for use of other combustible nicotine-containing tobacco products at the 12-month follow-up-in order to differentiate them from use of cigarettes at 12 months.
Measured: At 3- and 6- months post-randomization
Measures of bond between user and conversational chatbot
Will be measured via four subscales of the 12-item Working Alliance Inventory for Tobacco (WAIT-12), with technology intervention adaptations similar to those of prior chatbot research. Will calculate the proportion of treatment effect explained by each of the mediators. Number of times participants engaged with the intervention will be adjusted in Poisson regressions that account for the number of prompts a participant received.
Measured: At 3- and 6-months post-randomization
Agreement on goals of treatment
Will be measured via four subscales of the WAIT-12, with technology intervention adaptations similar to those of prior chatbot research. Will calculate the proportion of treatment effect explained by each of the mediators.
Measured: At 3- and 6-months post-randomization
Agreement on tasks of treatment
Will be measured via four subscales of the WAIT-12, with technology intervention adaptations similar to those of prior chatbot research. Will calculate the proportion of treatment effect explained by each of the mediators.
Measured: At 3- and 6-months post-randomization
User's sense that QuitBot understands their needs
Will be measured via four subscales of the WAIT-12, with technology intervention adaptations similar to those of prior chatbot research. Will calculate the proportion of treatment effect explained by each of the mediators.
Measured: At 3- and 6-months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start30 Nov 2026 (estimated)
- Primary completion31 Oct 2029 (estimated)
- Study completion31 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette Smoking-Related CarcinomaStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 772 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Jonathan Bricker, PhD, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697496
- Sponsor's protocol ID
- RG1124884
- Other IDs
- NCI-2024-08892, U19MD020533, FHIRB0020651
- Status last verified
- Jun 2026
- First submitted
- 18 Nov 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The trial results data will be published on ClinicalTrials.gov. The de-identified scientific data will be made available as public use data to the research community in openICPSR. No PII or PHI data will be shared or available for secondary use.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Navigation and Artificial Intelligence Technology for Indigenous Virtual Education on Smoking Cessation (NAITIVE)
- ClinicalTrials.gov ID
- NCT06697496
- Acronym / sponsor ID
- RG1124884
- Conditions
- Cigarette Smoking-Related Carcinoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 772 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 31 Oct 2030 (estimated)
- First posted
- 20 Nov 2024 (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 develops a chatbot smartphone application (app), QuitBot, and text messaging to help American Indians (AI) and Alaska Natives (AN) to quit smoking commercial tobacco (smoking cessation), and evaluates two remote smoking cessation programs to see how well they work for helping AI/AN people quit smoking commercial tobacco. AI/AN populations have one of the highest rates of commercial cigarette smoking of any racial and ethnic group in the United States (US). They also have a higher rate of developing smoking-related cancer but are less likely to quit smoking. The two programs are designed to provide personalized support in setting a smoking cessation goal, tasks to reach the smoking cessation goal, and motivation to remain smoke-free. This may help to keep participants engaged and support them in their quit efforts, and may improve smoking cessation among AI and AN.
Detailed description
OUTLINE: Participants are randomized to 1 of 2 arms. Both groups receive access to a 42-day quit smoking program.
ARM I: Participants receive daily QuitBot program chatbot messages about the importance of quitting smoking, setting a quit date, preparing to quit, quitting, and maintaining abstinence over 42 days.
ARM II: Participants receive daily QuitBot text messages about the importance of quitting smoking, setting a quit date, preparing to quit, quitting, and maintaining abstinence over 42 days.
After completion of study intervention, participants are followed up at 3, 6, and 12 months and may be contacted thereafter for up to 24 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (QuitBot chatbot) | Experimental | Device: QuitBot Smoking Cessation Chatbot Program, Other: Survey Administration, Other: Interview, Procedure: Carbon Monoxide MeasurementParticipants participate in the QuitBot program which involves chatbot messages over 42 days. Therapy description withheld to protect the integrity of the study. |
| Arm II (QuitBot texting) | Active comparator | Device: QuitBot Smoking Cessation Text Messaging Program, Other: Survey Administration, Procedure: Carbon Monoxide MeasurementParticipants participate in the QuitBot program which involves text messages over 42 days. Therapy description withheld to protect the integrity of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Self-identifying as American Indian or Alaska Native, either alone or in combination with other races
- Age 18 and older
- Smoking combustible cigarettes daily in the past year
- Interest in quitting smoking
- Interest in learning skills to quit smoking
Key exclusion criteria (3 listed)
- The reverse of the inclusion criteria
- Pregnant or breastfeeding
- Use of other tobacco products (e.g., ceremonial use of tobacco, e-cigarettes) will be assessed but is not an exclusion criterion, as it would limit the study's generalizability
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 |
|---|---|---|
| QuitBot Smoking Cessation Chatbot ProgramAlso: QuitBot chatbot programParticipate in Quitbot chatbot program | Device | Arm I (QuitBot chatbot) |
| QuitBot Smoking Cessation Text Messaging ProgramAlso: QuitBot texting programParticipate in Quitbot texting program | Device | Arm II (QuitBot texting) |
| Survey AdministrationAncillary studies | Other | Arm I (QuitBot chatbot), Arm II (QuitBot texting) |
| InterviewAncillary studies | Other | Arm I (QuitBot chatbot) |
| Carbon Monoxide MeasurementAlso: CMONOXAncillary studies | Procedure or surgery | Arm I (QuitBot chatbot), Arm II (QuitBot texting) |
Primary outcome
30-day point prevalence abstinence (PPA)
Time frame: At 12-months post-randomization
Will use a logistic regression model and standard smoking cessation trial intent-to-treat analysis, with all missing outcomes will be coded as smoking. The model will adjust for stratification factors and baseline factors that are significantly related to the outcome. Sensitivity analyses will include: (1) multiple imputation of missing outcomes, (2) complete case analysis, and (3) carbon monoxide (CO)-verified results adjusted for use of other combustible nicotine-containing tobacco products at the 12-month follow-up-in order to differentiate them from use of cigarettes at 12 months.
5 secondary outcomes
30-day PPA
Time frame: At 3- and 6- months post-randomization
Measures of bond between user and conversational chatbot
Time frame: At 3- and 6-months post-randomization
Agreement on goals of treatment
Time frame: At 3- and 6-months post-randomization
Agreement on tasks of treatment
Time frame: At 3- and 6-months post-randomization
User's sense that QuitBot understands their needs
Time frame: At 3- and 6-months post-randomization
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 20 Oct 2026.
- Individual participant dataSharing planned: Yes. The trial results data will be published on ClinicalTrials.gov. The de-identified scientific data will be made available as public use data to the research community in openICPSR. No PII or PHI data will be shared or available for secondary use.
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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 Bricker, PhD 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 QuitBot Smoking Cessation Chatbot Program, QuitBot Smoking Cessation Text Messaging Program 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 16 inclusion and 3 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: opening soon, as of the sponsor's last update on 20 Oct 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 Jonathan Bricker, PhD (206-667-5074, jbricker@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?
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 20 Oct 2026.