A Smartphone Application (QuitBot) for the Improvement of Smoking Cessation Among American Indians and Alaska Natives, NAITIVE Trial

NCT06697496 | Not Yet Recruiting FDA Device

• 4 other identifiers: RG1124884NCI-2024-08892U19MD020533FHIRB0020651
• Study Type: interventional
• Target: 772
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Cigarette Smoking-Related Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  At 12-months post-randomization

Secondary Outcomes (5)

• 30-day PPA

  At 3- and 6- months post-randomization

• Measures of bond between user and conversational chatbot

  At 3- and 6-months post-randomization

• Agreement on goals of treatment

  At 3- and 6-months post-randomization

• Agreement on tasks of treatment

  At 3- and 6-months post-randomization

• User's sense that QuitBot understands their needs

  At 3- and 6-months post-randomization

Study Arms (2)

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.

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.

Device: QuitBot Smoking Cessation Text Messaging Program; Other: Survey Administration; Procedure: Carbon Monoxide Measurement

Interventions

QuitBot Smoking Cessation Text Messaging Program DEVICE

Participate in Quitbot texting program

Also known as: QuitBot texting program

Arm II (QuitBot texting)

Interview OTHER

Ancillary studies

Arm I (QuitBot chatbot)

Carbon Monoxide Measurement PROCEDURE

Ancillary studies

Also known as: CMONOX

Arm I (QuitBot chatbot); Arm II (QuitBot texting)

QuitBot Smoking Cessation Chatbot Program DEVICE

Participate in Quitbot chatbot program

Also known as: QuitBot chatbot program

Arm I (QuitBot chatbot)

Survey Administration OTHER

Ancillary studies

Arm I (QuitBot chatbot); Arm II (QuitBot texting)

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• Pregnant or breastfeeding

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Interventions

Interviews as Topic; Carbon Monoxide

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Carbon Compounds, Inorganic; Inorganic Chemicals; Gases; Oxides; Oxygen Compounds

Study Officials

• Jonathan Bricker, PhD

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Bricker, PhD

CONTACT

206-667-5074; jbricker@fredhutch.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Random assignments will be concealed from participants and researchers throughout the trial. Follow-up data will be collected by survey research unit that will be blind to random assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): October 31, 2030
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The de-identified scientific data will be made available to other users no later than the time of publication of the primary outcomes, or at the end of the performance period, whichever comes first. The de-identified data deposited in openICPSR will be available to the research community in perpetuity.
• Access Criteria: Members of the research community using this data must register with ICPSR and agree to the Terms of Use, which include limiting data use to scientific research and aggregate statistical reporting, prohibiting attempts to identify study participants, requiring immediate reporting of any disclosure of participant identity, and requiring users agree not to share or redistribute any data downloads.

Locations

US (1)