Tobacco UseNCT05447156
QuitGuide for American Indians: Aims 2 & 3
A study testing Tailored QuitGuide app and Standard QuitGuide app in people with Tobacco Use and Tobacco Use Disorder, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
Aim 3: To test feasibility, acceptability, and preliminary efficacy of the tailored QuitGuide for smoking cessation among AIs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use, Tobacco Use Disorder
- What is being tested?
- Tailored QuitGuide app and Standard QuitGuide app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2022to 29 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center - University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Aim 3: To test feasibility, acceptability, and preliminary efficacy of the tailored QuitGuide for smoking cessation among AIs.
- Conditions
- Tobacco Use, Tobacco Use Disorder
- Being tested
- Tailored QuitGuide app, Standard QuitGuide app
- Medical subject headings
- Tobacco Use, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored QuitGuide appBehavioural
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.
Standard QuitGuide appBehavioural
This is an app available to the public.
| Study group | Role | What they receive |
|---|---|---|
| Aim 3:Tailored App | Experimental | Randomized subset of participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone. Receives: Behavioral: Tailored QuitGuide app |
| Aim 3: Standard App | Placebo comparator | Randomized subset of participants will use the standard QuitGuide app, a smoking cessation app available to the public, downloaded to their personal phone. Receives: Behavioral: Standard QuitGuide app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks post enrollment and 1 week post randomization
Secondary outcomes (5)
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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 weeks post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start14 Dec 2022
- Primary completion25 Sep 2023
- Study completion29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Aim 3: Participants will be randomized to either the tailored QuitGuide app or the standard version of the QuitGuide app for 5 weeks.
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dana Caroll, PhD, Principal investigator, Masonic Cancer Center, Univeristy of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447156
- Sponsor's protocol ID
- SPH-2022-30604
- Other IDs
- MCC CPRC
- Status last verified
- Mar 2025
- First submitted
- 1 Jul 2022
- Last updated
- 11 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QuitGuide for American Indians: Aims 2 & 3
- ClinicalTrials.gov ID
- NCT05447156
- Acronym / sponsor ID
- SPH-2022-30604
- Conditions
- Tobacco Use, Tobacco Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- 25 Sep 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 7 Jul 2022 (actual)
- Results
- Posted 11 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim 3: To test feasibility, acceptability, and preliminary efficacy of the tailored QuitGuide for smoking cessation among AIs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Aim 3: Participants will be randomized to either the tailored QuitGuide app or the standard version of the QuitGuide app for 5 weeks.
| Arm | Type | Receives |
|---|---|---|
| Aim 3:Tailored App | Experimental | Behavioral: Tailored QuitGuide appRandomized subset of participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone. |
| Aim 3: Standard App | Placebo comparator | Behavioral: Standard QuitGuide appRandomized subset of participants will use the standard QuitGuide app, a smoking cessation app available to the public, downloaded to their personal phone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored QuitGuide appThis is an app not available to the public. It was developed/tailored based on an app available to the public and can be downloaded. | Behavioural | Aim 3:Tailored App |
| Standard QuitGuide appThis is an app available to the public. | Behavioural | Aim 3: Standard App |
Primary outcome
Frequency of App Use
Time frame: 5 weeks post enrollment and 1 week post randomization
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 secondary outcomes
Study Attrition Measured as Percentage of Randomized Participants That Complete the Final Phone Interview at 5 Weeks
Time frame: 5 weeks post enrollment aim 3
Frequency of Returning Saliva Sample by 2 Weeks Post the Week 5 Interview
Time frame: 5 weeks post enrollment aim 3
Usability of App Design Measured Using System Usability Scale (SUS)
Time frame: 5 weeks post enrollment
Acceptability of Overall App
Time frame: 5 weeks post enrollment
Fit of App With Culture
Time frame: 5 weeks post enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Tobacco Use
Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
Developing an E-Cigarette Cessation Intervention for Hispanic/Latina(o) Youth in Florida: The BReATHE Study
Vaping Teens, Vaping Behaviors
Not yet recruiting
Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
Tobacco Cessation, Electronic Nicotine Delivery Systems
Recruiting
Developing a Scalable Tobacco Cessation Program for Cancer Survivors and Caregivers
Nicotine Use, Tobacco Use
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dana Caroll, PhD principal investigator
Masonic Cancer Center, Univeristy of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored QuitGuide app and Standard QuitGuide app in people with Tobacco Use and Tobacco Use Disorder, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of App Use (time frame: 5 weeks post enrollment and 1 week post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.