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Not yet recruiting NCT06697496

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

No phase Interventional Cigarette Smoking-Related Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: QuitBot Smoking Cessation Chatbot Program, QuitBot Smoking Cessation Text Messaging Program, Survey Administration, Interview.
Who it may be relevant to
Registry conditions: Cigarette Smoking-Related Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Navigation and Artificial Intelligence Technology for Indigenous Virtual Education on Smoking Cessation (NAITIVE)

Overview

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.

Interventions

  • Device QuitBot Smoking Cessation Chatbot Program
    Participate in Quitbot chatbot program
  • Device QuitBot Smoking Cessation Text Messaging Program
    Participate in Quitbot texting program
  • Other Survey Administration
    Ancillary studies
  • Other Interview
    Ancillary studies
  • Procedure Carbon Monoxide Measurement
    Ancillary studies

Primary outcome measures

  • 30-day point prevalence abstinence (PPA) [Time frame: At 12-months post-randomization]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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
  • Providing email, phone number(s), and mailing address

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Fred Hutch/University of Washington Cancer Consortium — Seattle

Identifiers

NCT: NCT06697496 · RG1124884 · NCI-2024-08892 · U19MD020533 · FHIRB0020651

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗