QuitGuide for American Indians: Aims 2 & 3

NCT ID: NCT05447156

Last Updated: 2025-04-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-14

Study Completion Date

2023-11-29

Brief Summary

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Aim 3: To test feasibility, acceptability, and preliminary efficacy of the tailored QuitGuide for smoking cessation among AIs.

Detailed Description

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Conditions

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Tobacco Use Tobacco Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Aim 3: Participants will be randomized to either the tailored QuitGuide app or the standard version of the QuitGuide app for 5 weeks.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Aim 3:Tailored App

Randomized subset of participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone.

Group Type EXPERIMENTAL

Tailored QuitGuide app

Intervention Type BEHAVIORAL

This is an app not available to the public. It was developed/tailored based on an app available to the public and can be downloaded.

Aim 3: Standard App

Randomized subset of participants will use the standard QuitGuide app, a smoking cessation app available to the public, downloaded to their personal phone.

Group Type PLACEBO_COMPARATOR

Standard QuitGuide app

Intervention Type BEHAVIORAL

This is an app available to the public.

Interventions

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Tailored QuitGuide app

This is an app not available to the public. It was developed/tailored based on an app available to the public and can be downloaded.

Intervention Type BEHAVIORAL

Standard QuitGuide app

This is an app available to the public.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* American Indian person based on self-report
* Age ≥ 18 years
* Interested in quitting smoking
* Smoke ≥ 3 commercial tobacco cigarette per day (CPD) in the past 30 days

o Use of other commercial tobacco products (e.g., e-cigarettes) is permitted if they report cigarettes being their primary product
* Smartphone ownership with the ability to download applications and sufficient data to complete research procedures

Exclusion Criteria

* New or change in pharmacotherapy for smoking cessation (includes: nicotine gum, patch, lozenge, inhaler OR medications Chantix/Wellbtrutin/Zyban/Bupropion) in past month
* Does not speak or read English
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dana Caroll, PhD

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, Univeristy of Minnesota

Locations

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Masonic Cancer Center - University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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MCC CPRC

Identifier Type: OTHER

Identifier Source: secondary_id

SPH-2022-30604

Identifier Type: -

Identifier Source: org_study_id

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