Clinical trial NCT06697496: A Smartphone Application (QuitBot) for the Improvement of Smoking Cessation Among American Indians and Alaska Natives, NAITIVE Trial
Official title: Navigation and Artificial Intelligence Technology for Indigenous Virtual Education on Smoking Cessation (NAITIVE)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cigarette Smoking-Related Carcinoma
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-11-20
Enrollment: 772
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

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

Primary outcomes:
measure: 30-day point prevalence abstinence (PPA)
timeFrame: At 12-months post-randomization
Secondary outcomes:
measure: 30-day PPA
timeFrame: At 3- and 6- months post-randomization
measure: Measures of bond between user and conversational chatbot
timeFrame: At 3- and 6-months post-randomization
measure: Agreement on goals of treatment
timeFrame: At 3- and 6-months post-randomization
measure: Agreement on tasks of treatment
timeFrame: At 3- and 6-months post-randomization
measure: User's sense that QuitBot understands their needs
timeFrame: At 3- and 6-months post-randomization
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Jonathan Bricker, PhD
role: PRINCIPAL_INVESTIGATOR
References: