QuitGuide for American Indians: Aims 2 & 3

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

Study Overview

• Status: Completed
• Conditions: Tobacco Use; Tobacco Use Disorder
• Intervention / Treatment: Behavioral: Tailored QuitGuide app; Behavioral: Standard QuitGuide app

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Masonic Cancer Center - University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aim 3:Tailored App; Randomized subset of participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone.	Behavioral: 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.
Placebo Comparator: 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.	Behavioral: Standard QuitGuide app; This is an app available to the public.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of App Use	The number of times the app is initiated per day will be measured using data from Smokefree.gov. If a participant does not use the app on a particular day, Smokefree.gov records this as non-use or 0 for that day. The total number of times will be summarized for analysis by totaling the number of times the app is initiated from randomization to 5 weeks post-randomization.	5 weeks post enrollment and 1 week post randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study Attrition Measured as Percentage of Randomized Participants That Complete the Final Phone Interview at 5 Weeks	Percentage of randomized participants that complete the final phone interview at 5 weeks	5 weeks post enrollment aim 3
Frequency of Returning Saliva Sample by 2 Weeks Post the Week 5 Interview	Count of randomized participants that return saliva sample 2 weeks after the 5 weeks post enrollment (end of intervention)	5 weeks post enrollment aim 3
Usability of App Design Measured Using System Usability Scale (SUS)	Scores for each question (1-5) are added together for an overall score of 100. 100 means the website is rated at optimal usability. Scores lower than 100 indicate the website needs improvements. Mean and standard deviations or medians and ranges of percentile rankings will be calculated. Minimum score of zero.	5 weeks post enrollment
Acceptability of Overall App	Mean and standard deviations or medians and ranges of Likert-scale responses to questions such as 'How likely would you be to recommend the app to a friend?'. Rated out of 7 points. 7 is the highest score, indicating participants are very likely to recommend the app to a friend. Scores lower than 7 indicate participants are less likely to recommend the app. Minimum score of zero.	5 weeks post enrollment
Fit of App With Culture	Mean and standard deviations or medians and ranges of Likert-scale responses to questions such as 'The app fits my American Indian culture such as its history, traditions, and customs'. Rated out of 7 points. 7 is the highest score, indicating participants feel app fits the American Indian culture. Scores lower than 7 indicate participants don't feel as strongly that app fits American Indian culture. Minimum score of zero.	5 weeks post enrollment

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota
• Investigators: Principal Investigator: Dana Caroll, PhD, Masonic Cancer Center, Univeristy of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2022
• Primary Completion (Actual): September 25, 2023
• Study Completion (Actual): November 29, 2023

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: July 1, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Tobacco Use Disorder
• Other Study ID Numbers: SPH-2022-30604; MCC CPRC (Other Identifier: 2022LS018)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No