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

Not Applicable

Not yet recruiting

• Conditions: Cigarette Smoking-Related Carcinoma

• Registration Number: NCT06697496
• Lead Sponsor: Fred Hutchinson Cancer Center

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...

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.
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-18
• Last Update Submitted: 2024-11-18
• Study First Posted: 2024-11-20
• Last Update Posted: 2024-11-20
• Study Start: 2025-04-01
• Primary Completion: 2029-10-31
• Study Completion: 2030-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 772

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
30-day point prevalence abstinence (PPA)	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) complet...

Secondary Outcome Measures

Name	Time	Method
30-day PPA	At 3- and 6- months post-randomization	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 wi...
Measures of bond between user and conversational chatbot	At 3- and 6-months post-randomization	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 r...
Agreement on goals of treatment	At 3- and 6-months post-randomization	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.
Agreement on tasks of treatment	At 3- and 6-months post-randomization	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.
User's sense that QuitBot understands their needs	At 3- and 6-months post-randomization	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.

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States