QuitGuide for American Indians: Aims 2 & 3
Phase: NA
Conditions: Tobacco Use, Tobacco Use Disorder
Sponsor: Masonic Cancer Center, University of Minnesota

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: QuitGuide for American Indians: Aims 2 & 3 
 
 
VERSION DATE: 11-16-2022 
 
Page 1 of 29 
 
ANCILLARY REVIEWS 
DO NOT DELETE.  Submit the completed checklist below with your protocol. 
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Select yes or 
no 
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If yes… 
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locations 
Gillette Scientific review and Gillette 
Research Administration approval is 
required.  Contact: 
research@gillettechildrens.com   
Required 
prior to IRB 
submission 
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☒ No 
 
Involve Epic, or Fairview patients, 
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Approval 
must be 
received 
prior to IRB 
committee/ 
designated 
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Consider 
seeking 
approval 
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submission. 
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Include evaluation of drugs, 
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MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: QuitGuide for American Indians: Aims 2 & 3 
 
 
VERSION DATE: 11-16-2022 
 
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☐ Yes 
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Include the use of human fetal 
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embryonic stem cells? 
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PROTOCOL COVER PAGE 
 
 
 
Protocol Title 
QuitGuide for American Indians: Aims 2 & 3 
Principal 
Investigator/Faculty 
Advisor 
Name: Dana Carroll  
Department: Public Health, Div. of Environmental Health Sciences 
Telephone Number: 612-624-0132 
Email Address:  dcarroll@umn.edu 
Scientific Assessment 
Nationally-based, federal funding organizations 
IND/IDE # (if 
applicable) 
Not applicable 
IND/IDE Holder 
Not applicable 
Investigational Drug 
Services # (if 
applicable) 
Not applicable 
Version Number/Date: 
Version 6- November 16 2022  
 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: QuitGuide for American Indians: Aims 2 & 3 
 
 
VERSION DATE: 11-16-2022 
 
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VERSION HISTORY 
 
Version # 
Version Date 
Summary of Changes 
Consent Change? 
1 
1/18/2022 
N/A 
N/A 
There was a protocol version date of 3/10/2022 that was submitted to CPRC, and incorporated 
responses to CPRC stipulations and approved by CPRC but somehow the changes that were reflected 
in the 3/10/2022 version, were not included in future versions of the protocol (i.e., 5/5/2022 and 
6/23/2022). Therefore, the 8/22/2022 version includes these missing edits/line changes that were 
previously approved by CPRC and reflects the current protocol. We have also resent the 8/22/2022 
version back to CPRC for review as an amendment. 
2 
5/5/2022 
• 
HIPCO Review not required. 
Updating and removing 
references to HIPAA 
• 
Updated compensation structure 
• 
Clarified compensation for exit 
survey versus exit interview  
N/A 
3 
6/23/2022 
• 
Updating time window for full 
compensation for exit survey 
• 
Added a secondary outcome 
measure that was previously 
missing in error to align with our 
SAP. 
Yes-consent was 
updated to version 
6/13/2022 to reflect 
time widow update. 
No participants 
enrolled, (not yet IRB 
approved).  
4 
8/22/2022 
-Updating consent and protocol to 
include Oklahoma State as study site 
-Updating Aim 2 to include only one 
wave of user testing 
--Adding protocol modifications that 
were reflected in a 3/10/2022 version of 
the protocol were inadvertently missing 
from the prior versions (5/5/2022 and 
6/23/2022) 
Yes to version 8-22-
2022 
5 
10/20/2022 
-dropping Oklahoma State as study site 
-updating order of baseline survey versus 
app download. 
Yes to version 10-20-
2022 
6 
11-16-2022 
Dropping Aim 2 pilot run due to time 
restraints and going straight to Aim 3 
which is now the focus of this protocol.  
Adding an exit interview/follow-up 
interview conducted among a subset of 
participants in the tailored arm only.  
Yes to version 11-16-
2022 
 
 
 
 
 
 
 

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VERSION DATE: 11-16-2022 
 
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Table of Contents 
 
1.0 
Objectives ...................................................................................................................................... 7 
2.0 
Background .................................................................................................................................... 7 
3.0 
Study Endpoints/Events/Outcomes ............................................................................................. 10 
4.0 
Study Intervention(s)/Investigational Agent(s) ........................................................................... 11 
5.0 
Procedures Involved .................................................................................................................... 11 
6.0 
Data and Specimen Banking ........................................................................................................ 13 
7.0 
Sharing of Results with Participants ............................................................................................ 13 
8.0 
Study Population .......................................................................................................................... 13 
9.0 
Vulnerable Populations ................................................................................................................ 14 
10.0 
Local Number of Participants ...................................................................................................... 15 
11.0 
Local Recruitment Methods ........................................................................................................ 16 
12.0 
Withdrawal of Participants .......................................................................................................... 16 
13.0 
Risks to Participants ..................................................................................................................... 17 
14.0 
Potential Benefits to Participants ................................................................................................ 17 
15.0 
Statistical Considerations............................................................................................................. 17 
16.0 
Health Information and Privacy Compliance ............................................................................... 20 
17.0 
Confidentiality.............................................................................................................................. 23 
18.0 
Provisions to Monitor the Data to Ensure the Safety of Participants ......................................... 23 
19.0 
Provisions to Protect the Privacy Interests of Participants ......................................................... 23 
20.0 
Compensation for Research-Related Injury ................................................................................. 24 
21.0 
Consent Process ........................................................................................................................... 24 
22.0 
Setting .......................................................................................................................................... 24 
23.0 
Multi-Site Research ...................................................................................................................... 25 
24.0 
Coordinating Center Research ..................................................................................................... 25 
25.0 
Resources Available ..................................................................................................................... 26 
26.0 
References ....................................................................................... Error! Bookmark not defined. 

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ABBREVIATIONS/DEFINITIONS 
• 
AI: American Indian, referring to Native American individuals from the continental United 
States. 
• 
Commercial tobacco: Tobacco products produced for commercial gain and containing 
chemical additives harmful to health. Examples include cigarettes and vaping liquid.  
• 
Traditional tobacco: All-natural tobacco, which may or may not be ingested, that is grown 
and utilized for ceremonial purposes in various American Indian traditions. 
• 
AICAF: American Indian Cancer Foundation  
 
 

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1.0 
Objectives 
1.1 
Purpose:  
This protocol is for a NIH funded study.  
 
To test feasibility, acceptability, and preliminary efficacy of the tailored QuitGuide for smoking 
cessation among AIs. Our hypothesis is that the tailored QuitGuide will have higher ratings of 
feasibility and acceptability compared to the standard, publicly available QuitGuide among AI 
smokers.  Additionally, we hypothesize that the tailored QuitGuide will have similar ratings of 
feasibility and acceptability among participants in OK compared with participants in MN/WI. 
2.0 
Background 
2.1 
Significance of Research Question/Purpose:  
There is a need to better serve American Indian (AI) peoples in quitting commercial tobacco 
use. In many AI tribes, there is a long history of the use of tobacco for ceremonial and spiritual 
purposes. In the last century, however, the addictive use of commercially produced tobacco has 
increased dramatically among AI peoples. This disparity is particularly evident in the northern 
plains region of the U.S. in states such as Minnesota where an estimated 59% of AI adults 
identified as current smokers  relative to 16% of the White population.1 Consequently, and as 
shown in prior research by our team, AI peoples experience disproportionately higher rates of 
tobacco-related morbidity and mortality, such as lung cancer, as much as three-fold more that 
of White persons.2-4 While the proportion of AI smokers who attempted to quit in the past year 
is similar to the general population (53% versus 56%), the percentage of AI ever smokers who 
are former smokers is roughly half that of the general population (29% versus 56%).5,6   
 
Lower quitting among AI peoples is due to a number of factors, including poor engagement 
with available treatments.  Many factors contribute to low quitting rates among AI peoples, 
including early age of smoking initiation which is associated with greater dependence,7 
infiltration of commercial cigarettes into ceremonies, funerals, and pow wows instead of 
traditional tobacco,8 tobacco industry targeting of AIs as shown in our prior research,9 stress and 
historical and contemporary trauma, socioeconomic challenges, and mistrust of health 
providers. Lack of access to or availability of culturally-tailored treatments is likely another 
important contributor.  
 
2.2 
Preliminary Data:  
NCI’s QuitGuide is a publicly available smartphone app for cessation. QuitGuide follows US 
Clinical Practice Guidelines which are the gold-standard in cessation treatment.20 Guidelines call 
for tracking smoking status, offering quit planning, pharmacotherapy advice, tools to enhance 
motivation, and social support.20 QuitGuide allows the user to track mood and cravings any time 
of the day, provides motivational messages and quit tips, and includes GPS technology which 
allows the user to mark a location as a trigger and then the app sends the user an alert and quit 
tip if they approach the location. QuitGuide was downloaded >100,000 times from 2015-2018 
(personal communication w/Mr. Kendrick at Smokefree.gov; Smokefree.gov is managed by the 

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National Cancer Institute and the QuitGuide is a Smokefree.gov product). In testing of mainly 
White smokers without providing pharmacotherapy, QuitGuide was viewed as feasible and 
potentially efficacious as 8% quit (non-biochemically verified).15 Although the QuitGuide’s quit 
rate is lower than face-to-face studies that include pharmacotherapy,21-23 the reach and 
therefore the absolute number of people quitting with QuitGuide is potentially far greater. Given 
prior studies like the aforementioned ANBL that observed numerically lower abstinence among 
AIs in the non-tailored versus culturally-tailored arm, we hypothesize that the QuitGuide fails 
to maximize quitting among AIs, but can be improved if tailored. 
 
There are several avenues for tailoring the QuitGuide to better fit the culture and needs of AI 
smokers. QuitGuide uses conventional tobacco control messages that portray tobacco entirely 
negatively which may be offensive and ineffective among AI persons for whom ceremonial 
tobacco use is part of spiritual practice. This may be overcome by distinguishing commercial 
versus traditional tobacco use in the app and embedding previously developed content on 
traditional tobacco use to reframe how tobacco should be used. Such content may include 
resources on traditional tobacco use that are publicly available through the National Native 
Network Keep Tobacco Sacred website.24 Additionally, while the QuitGuide provides guidance to 
triggers common to the general population such as drinking coffee , it does not include triggers 
unique to AI persons such as cigarette use at pow wows, funerals, ceremonies and in the home. 
Since smoking is pervasive in the environments of many AI persons, equipping AIs with how to 
combat triggers unique to their environment as well as triggers shared with the general 
population may be particularly effective. Another tailoring avenue is the inclusion of links to 
short videos on quit tips from AI persons themselves created by CDC’s Tips from Former Smokers 
Campaign.25 An additional avenue for tailoring may include emphasis on younger generations 
and communities at large to encourage quitting. This could be done through providing the option 
to upload family photos to the app. 
 
Rigor of prior research and scientific premise of the proposed study:  
• 
There is evidence from our team and others that there is a significant public health problem 
of commercial smoking among AIs2-4 and while many AIs want to quit, lifetime quitting is 
lower among AI peoples compared to those from other racial/ethnic backgrounds.5,6    
• 
While not reaching statistical significance, quit rates in face-to-face interventions such as 
ANBL were numerically higher if culturally-tailored to AIs.10,11 This is also evidence that face-
to-face delivery, even if culturally-tailored, suffers from low engagement due to participant 
barriers like transportation. 10,11  
• 
Smartphone-delivered interventions allow for immediate access to interactive, readily 
tailorable, treatment content;15 therefore, these interventions have great potential for 
reaching and engaging AI smokers.  
• 
QuitGuide is a smartphone app with evidence for cessation efficacy in predominately White 
smokers.15 QuitGuide provides real-time guidance on how to navigate triggers resulting from 
the smoker’s environment which could be particularly effective for AIs given the high 
prevalence of smoking in many AI communities. However, at present QuitGuide does not 
include guidance on triggers unique to AI persons such as cigarettes use at funerals, pow 
wows, and by others in the home. Additionally, the QuitGuide uses conventional messages 
that portray tobacco entirely negatively and does not address traditional tobacco. This is 
problematic because of our team’s data showing that cultural references to traditional 

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tobacco in smoking cessation messages can positively affect message and cessation 
perceptions (AICAF unpublished data). The need for tailoring the QuitGuide to better fit the 
needs of AI persons is further supported by prior interventions that showed higher 
abstinence in groups receiving culturally tailored treatment.10,11 
2.3 
Existing Literature:  
Evidence suggests that culturally-tailored interventions may increase cessation in AIs but face-
to-face delivery is costly and hindered by lack of transportation among participants. Prior work 
by the American Indian Cancer Foundation (AICAF; subcontract on proposal), shows that 
references to traditional tobacco in cessation messages can positively affect self-efficacy to quit 
(unpublished data). To our knowledge, only two culturally-tailored cessation interventions for AI 
peoples exist that purposely engage AI voices throughout the research and utilized rigorous 
methodology (i.e., included a control group, biochemically confirmed abstinence). The first is the 
All Nations Breath of Life (ANBL) intervention which was created for AIs representing many tribes 
and included pharmacotherapy, in-person behavioral support led by AI facilitators, and 
culturally-tailored curriculum.10 Biochemically confirmed abstinence was higher in the tailored 
versus standard group, though the difference between the groups was not statistically significant 
(11% vs 7%).10 The second, a tribal-specific program which included pharmacotherapy, also 
observed higher, but non-significant, abstinence in the tailored versus standard group (23% vs 
14%).11 Both studies observed poor retention (~40% loss-to-follow-up) and lack of transportation 
was a major contributor. Innovative approaches that can reach AI smokers and, that overcome 
the barrier of travel to an intervention site are needed to address commercial smoking among 
AI people.   
 
Mobile health (mHealth) interventions, can have broad reach, be delivered conveniently and 
efficiently, and can be tailored to be engaging and culturally appropriate for AI people, offer 
promise for overcoming obstacles to delivering the traditional modes of cessation treatment. 
Web-based and text messaging interventions have the advantage of convenience and may be 
well-suited for a cessation intervention due to cost effectiveness and scalability. A 2020 U.S. 
Surgeon General report concluded that these mHEALTH approaches increase cessation.12 Two 
ongoing studies are using the web13 or text-messaging14 to deliver culturally-tailored cessation 
treatment to AIs. However, the increasing use of smartphones offers a new mHEALTH platform 
known as smartphones applications (“apps”) that offer new intervention content modalities 
and extend elements of the web and texting to create more interactive and visually appealing 
content. Apps have several features that make them appealing for a smoking cessation 
intervention: (1) treatment content available at arm's reach, (2) tracking progress anywhere and 
anytime including tailored support to environments that trigger smoking cues (e.g., car, bar), (3) 
video/audio capabilities, (4) after initial download, access without cellular or internet 
connection which is particularly advantageous due to our prior research experience with AI 
persons who can lack minutes or internet connection, and (5) content sharable via social media.15  
 
High smartphone ownership among AI peoples suggests potential high reach of a smartphone 
delivered cessation intervention in AI communities. Among U.S. adults in 2019, 81% owned a 
smartphone.16 A prior study reported 86% of AI peoples owned a cellular device, but this study 
did not make the distinction between smartphone versus non-smartphone ownership.17 
However, it is likely that the majority (>60%) of AI peoples own a smartphone based on high 
ownership estimates regardless of rural (71%) or urban location (81%) and the lowest estimate 

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of ownership was at 66%, which was among persons of low education.16 Additionally, a 2018 
study reported 86% of AI peoples use a smartphone as their news source.18 Finally, apps for 
Indigenous language preservation and revitalization are being used by Tribes, which suggests 
that apps are a promising platform for delivery of other content to AI peoples.19 
 
For all of these reasons, we are now proposing to test the feasibility and acceptability of a 
culturally-tailored version of the QuitGuide, developed by our team, versus the standard 
QuitGuide among American Indian persons in MN and WI.  
 
 
 
 
3.0 
Study Endpoints/Events/Outcomes 
3.1 
Primary Endpoint/Event/Outcome:  
The primary endpoint, which was used for power and sample size is the frequency of app use 
during the 5-week period.  
3.2 
Secondary Endpoint(s)/Event(s)/Outcome(s):  
Secondary endpoints: 
• 
Frequency of app use during the 1st week post-randomization 
• 
Frequency of interactions with various app features (e.g. quit tips, trigger list) over the 5 
weeks 
• 
Study accrual relative to recruitment goal 
• 
Study attrition measured as percentage of randomized participants that complete the 
survey at 5 weeks  
• 
Frequency of returning saliva sample by 2 weeks post the week 5 survey (i.e., 7 weeks 
post randomization) 
• 
Following measures at 5 weeks via exit survey 
o Usability of App Design measured using System Usability scale (SUS)34  
Acceptability of overall app (i.e., how likely would you be to recommend the app) 
and various app components (e.g. quit tips, trigger list) measured as Likert-scale 
responses  
Fit of app with culture measured as Likert-scale responses  
Exploratory endpoints:  
Following measures at 5 weeks via exit survey 
 
• 
Number of 24-hour quit attempts over the over the 5 week period 
• 
Self-reported 24-hour abstinence at time of exit survey 
• 
Self-reported 7-day abstinence at time of exit survey 
• 
Self-reported 30-day abstinence at time of exit survey 
• 
Nicotine replacement therapy and pharmacotherapy (e.g. Chantix) use over the 5 week 
period  
• 
Other behavioral support (e.g. in-person, quitline) for smoking cessation over the 5 week 
period 

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• 
Saliva cotinine at 5 weeks for those with 7-day abstinence prior to this time point to 
biochemically confirm self-reported 7-day abstinence (saliva cotinine < 10 ng/mL) 
4.0 
Study Intervention(s)/Investigational Agent(s) 
4.1 
Description:  
   
Participants will be randomized to either the tailored QuitGuide app or the standard version of 
the QuitGuide app for 5 weeks. Specifically, participants will be asked to use the assigned app 
for one week pre-quit and 4 weeks.  
 
Tailored QuitGuide app 
This is an app not available to the public. It was developed/tailored based on an app titled 
QuitGuide that is available to the public and can be downloaded. Screen shots of the publicly 
available version, referred to as the Standard QuitGuide app, are provided as an attachment. We 
have also included a document describing the changes and updates that were made to the 
Standard QuitGuide app to develop the Tailored QuitGuide app. 
 
Standard QuitGuide app 
This is an app titled QuitGuide that is available to the public and can be downloaded and screen 
shots are provided as an attachment. We will not provide all photos but several options are 
included in the IRB submission. 
 
4.2 
Drug/Device Handling:  
This study does not use a drug. The study will not be providing any device to participants. They 
will be expected to use their own cell phone for accessing the QuitGuide app.  
4.3 
Biosafety:  
No biosafety concerns or reviews required.  
4.4 
Stem Cells:  
This study does not use stem cells.  
4.5 
Fetal Tissue:  
This study does not use fetal tissue.  
5.0 
Procedures Involved 
5.1 
Study Design:  
This is a two-arm randomized clinical trial of the tailored vs standard QuitGuide app conducted.  
5.2 
Study Procedures:  
To test feasibility, acceptability, and preliminary efficacy of the tailored QuitGuide versus 
standard QuitGuide for smoking cessation among AI peoples.  
 
1. Telephone Screener: We will recruit AI smokers interested in quitting. Individuals will be 
screened over the phone for eligibility.  

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2. Phone-Based Baseline Interview: If eligible, then consent will be completed. Then, 
participants will complete a REDCap survey (titled Baseline Survey—see below for 
measures). Participants will be randomized to either the Tailored QuitGuide app or the 
Standard QuitGuide app.  Participants will be provided instruction on how to download 
the app to their smartphone. Upon download, all participants will be asked to provide a 
unique participant app ID in the app.  
 
Randomization: Participants will be randomized with equal probability to either a 
tailored version of the NCI QuitGuide or a standard version of the NCI QuitGuide. 
Randomization will be stratified by rural/urban clinic, male/female gender, and <50 
years of age/50+ years of age. Randomization will be completed using permuted block 
randomization with random block sizes of 2 and 4. We anticipate no or minimal block 
effects in our data, and therefore, we will not account for block effects in our data 
analysis. The randomization schedules will be created in advance. 
 
3. App interaction: Upon opening the app for the first time, participants will be asked to 
set a quit date. All participants will set their quit date for one week later to standardize 
pre- and post- quit times. If smoking relapse occurs,  participants will be provided the 
option to reset the quit date as this flexibility is permitted in the QuitGuide. Each 
participant will be asked to use the app for 5 weeks. Participants will have the option to 
contact the research coordinator at any time to report issues. At week 4, participants 
will be mailed a letter reminding them of the exit survey and will provide routine saliva 
sample collection kit with instructions to provide the sample on the same day of their 
exit survey, and materials (e.g., pre-paid envelope) to return the sample to the University 
of Minnesota for analysis. 
 
4. Exit Survey: At the end of the day on the last day of the 5 weeks of app use (i.e., 5 weeks 
+ 1 day), an automated survey link from REDCap will be sent to participants email to 
assess self-report outcome measures. Participants will also be called and texted to 
remind them to complete the survey.  
 
5. Optional end of study interview: Those randomized to the tailored QuitGuide may be 
asked to participate in a follow-up interview to get their feedback on using the app. We 
expect asking up to 10 people to complete this interview. 
 
All measures are displayed in the table: 
Baseline survey collected via REDCap: Demographics, America Indian Identity Measures, Internet 
and smartphone use,  Traditional Tobacco Use, Commercial Tobacco History, Nicotine Dependence 
Scale, Contemplation Ladder, Environmental Smoke Exposures, Health Literacy  
Alcohol consumption, Financial Strain, Perceived Stress Scale, Brief Resilience Scale, Everyday 
Discrimination Scale  
Data collected through using app and transferred from SmokeFree.gov:  
All app user data. Any and all interactions with the app including days and frequency of use each day 
and which app components are accessed.  

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Exit survey collected via REDCap: Contemplation Ladder TimeLine follow-back calendar to assess 
self-report CPD, use of any pharmacotherapy, 24-hour quit attempts, use of other cessation 
resources, Minnesota Nicotine Withdrawal Scale,  Usability of App Design by System Usability Scale 
(SUS) Acceptability measures; plus open-ended responses on app   
Audio recordings from the interviews among a subset of the participants 
Saliva Sample 
 
5.3 
Study Duration:  
• 
Individual participant duration is 5 weeks. 
• 
The duration to enroll all study participants is 1.5 years.  
• 
The duration for all data collection and analysis is 2.5 years.  
5.4 
Use of radiation:  
The study does not use any radiation.  
5.5 
Use of Center for Magnetic Resonance Research:  
The study does not use any CMMR resources.  
6.0 
Data and Specimen Banking 
 
Not applicable  
6.1 
Storage and Access:  Not applicable  
6.2 
Data: Not applicable  
6.3 
Release/Sharing: Not applicable  
7.0 
Sharing of Results with Participants 
No study results will be shared with participants. Individual results on any collected specimens 
will not be shared.   
8.0 
Study Population 
8.1 
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 
8.2 
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 

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• 
Does not speak or read English  
 
8.3 
Screening:  
Individuals are screened for eligibility by undergoing a phone screening interview with a 
research coordinator. The screening consists of questions about eligibility criteria. Participants 
who are eligible can then complete informed consent and enroll into the study—see informed 
consent section. 
9.0 
Vulnerable Populations 
9.1 Vulnerable Populations:  
Population / Group 
Identify whether any of the following 
populations will be focus of the 
research (targeted), included, but not 
necessarily the focus or excluded 
from participation in the study. 
Children 
Excluded 
Pregnant women/fetuses/neonates 
included but not the focus 
Prisoners 
Excluded 
Adults lacking capacity to consent 
and/or adults with diminished capacity 
to consent, including, but not limited 
to, those with acute medical conditions, 
psychiatric disorders, neurologic 
disorders, developmental disorders, 
and behavioral disorders 
Excluded 
Non-English speakers 
Excluded 
Those unable to read (illiterate) 
Excluded 
Employees of the researcher 
included but not the focus 
Students of the researcher 
included but not the focus 
Undervalued or disenfranchised social 
group 
included but not the focus 
Active members of the military (service 
members), DoD personnel (including 
civilian employees) 
included but not the focus 

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Individual or group that is approached 
for participation in research during a 
stressful situation such as emergency 
room setting, childbirth (labor), etc. 
Excluded 
Individual or group that is 
disadvantaged in the distribution of 
social goods and services such as 
income, housing, or healthcare. 
included but not the focus 
Individual or group with a serious 
health condition for which there are no 
satisfactory standard treatments. 
included but not the focus 
Individual or group with a fear of 
negative consequences for not 
participating in the research (e.g. 
institutionalization, deportation, 
disclosure of stigmatizing behavior). 
included but not the focus 
Any other circumstance/dynamic that 
could increase vulnerability to coercion 
or exploitation that might influence 
consent to research or decision to 
continue in research. 
included but not the focus 
 
9.2 Additional Safeguards, if any, to ensure inclusion is appropriate:  
Individuals representing these vulnerable groups are not targeted for inclusion but may be 
included if the eligibility criteria is met. While this study is targeting American Indians, a 
historically disadvantaged population, members of this group should not be assumed to 
automatically have additional vulnerabilities. 
9.3 
If research includes potential for direct benefit to participants, provide rationale for any 
exclusions indicated in the table above: 
There is potential for direct benefit of using a smoking cessation app. All exclusions listed above 
are related primarily to the smoking cessation app’s requirements.  
10.0 Local Number of Participants 
10.1 Local Number of Participants to be Consented:  
 
Up to 116 participants will be consented at the UMN/AICAF sites—all of these will be 
considered UMN accrual.  
 

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11.0 Local Recruitment Methods 
11.1 Recruitment Process:  
Recruitment will occur through social media and community events and news outlets. 
We also have recruited participants in one prior study (IRB: STUDY00012471: QuitGuide 
for American Indians: Aim 1  In STUDY00012471, we included a telephone screener form 
that specifically asks participants “Would you be interested in being contacted by us in 
the future if other research opportunities become available?". Those participants who 
responded “Yes” will be re-contacted by IRB approved study personnel on IRB: 
STUDY00012471 and reminded that they are being re-contacted due to their interest in 
future studies that was reported when they participated in IRB: STUDY00012471.  
11.2 Identification of Potential Participants:  
All participants will self-identify based on posted flyers and other recruitment materials OR 
recruited from IRB: STUDY00012471.   
11.3 Recruitment Materials:  
Pre-approved scripts and images will be used to develop flyers and postings. 
11.4 Payment:  
 A ClinCard (Greenphire through UMN) gift card will be provided as a physical card  mailed to 
the participant. Payment will be made as participant completes the following tasks: 
 
 
Total possible compensation for all participants is $125. Those asked to participate in a 
follow-up survey can receive an additional $25.  
1. Telephone Screener: No payment  
2. Virtual Baseline Interview: $25 payment        
3. App interaction: No payment 
4. Exit survey: $25 if completed within 48 hours or else $10 if completed not within 48 
hours 
5. Returned saliva sample: $25 payment  
6. Bonus for completing all study procedures: $50 
7. Follow-up interview among a subset of participants, invite only: $25 additional.  
 
 
12.0 Withdrawal of Participants 
12.1 Withdrawal Circumstances:  
Participants can choose to withdraw themselves at any time for any reason. Participants may 
be withdrawn by the PI if they no longer meet eligibility criteria.  
12.2 Withdrawal Procedures:  
If a participant is withdrawn, they will be informed and data collection will stop. All data or 
specimens collected up to that point will continue to be used. Compensation to that point will 
be provided. 

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12.3 Termination Procedures:  
If a participant is no longer eligible, they will be informed and data collection will stop. All data 
or specimens collected up to that point will continue to be used.  
13.0 Risks to Participants 
13.1 Foreseeable Risks:  
The potential risks of this study are minimal and include the risks associated with the loss of 
confidentiality, boredom of participating, and adverse psychological events from smoking 
reduction/cessation due to nicotine withdrawal.  
 
Nicotine withdrawal symptoms include sadness, difficultly sleeping, irritability, restlessness, 
anxiousness and are usually mild and fade with time. These symptoms present among smokers 
who quit in the real-world—not just exclusive to our study. The QuitGuide app has existing links 
to a 24-hour crisis center and information for participants to get help shall they need it as well 
as information on treatments (e.g., nicotine replacement therapy) to help reduce nicotine 
withdrawal. These resources will be maintained in the tailored version of the app. Nicotine 
withdrawal symptoms will be captured at the exit survey as part of an exploratory outcome via 
the Minnesota Nicotine Withdrawal Scale but will not be considered adverse events for this 
study.  
 
Measures collected will be noninvasive and should present no psychological or medical risk to 
the participant.  Participants will be told that they may refuse to answer any questions during 
baseline and follow-up surveys and they may decide to quit their participation at any time.  
 
13.2 Reproduction Risks:  
No risks to reproduction are expected with this study.  
13.3 Risks to Others:  
No risks to others are expected with this study.  
14.0 Potential Benefits to Participants 
14.1 Potential Benefits:  
As the intervention involves using a smoking cessation app, participants could benefit from 
using the app and quitting smoking. This benefit is not guaranteed. 
15.0 Statistical Considerations 
15.1 Data Analysis Plan:  
No blinding of the investigative team will occur. 
General Approach 
All statistical analyses will be performed using SAS (version 9.4) or R (latest version, R Core 
Team). All statistical tests will be two-sided and a significance level of 0.05 will be used.  Proper 
transformation such as the logarithm transformation will be used to approximate normality for 

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the outcome variables. All analyses will be completed using intent-to-treat principle unless 
otherwise noted. 
Describing the Study Population 
Baseline characteristics will be summarized for all participants and by study arm to identify any 
treatment group imbalances post-randomization. This will include household income, 
education level, traditional tobacco use, cultural identity, multiple tobacco use, quit readiness, 
nicotine dependence and CPD. Continuous variables will be summarized using mean, standard 
deviation, median and range, and compared between study arms using Student’s t-tests or 
Wilcoxon rank-sum tests, as appropriate. Categorical variables will be summarized using 
frequency and percentage, and compared between study arms using Chi-square or Fisher’s 
exact tests, as appropriate.   
Primary Endpoint Analysis 
The primary endpoint is the frequency of app use initiated by the participant. 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.  
Primary Analysis 
The objective of our primary analysis is to test the treatment effect on frequency of app 
initiated by the participant. Frequency of app initiated will be summarized by treatment group 
(tailored app vs standard app) using descriptive statistics, and analyzed using a Poisson 
regression model with covariates for treatment group and the three stratification factors 
(rural/urban clinic, male/female gender and <50 years of age/50+ years of age). Assumptions 
about mean and variance will be evaluated and if over-dispersion is present, negative binomial 
regression will be used. If data are zero-inflated, zero-inflated Poisson or negative binomial 
models may be considered.. This analysis will be performed using data for all participants who 
were randomized, while assuming non-use of app for those who did not complete the week 5 
survey from the last day they launched the app.   
Secondary Analysis 
A secondary analysis of the primary endpoint will be performed that also adjusts for any other 
covariates that differ across treatment groups at baseline with a p-value less than 0.20 
(covariates listed above). We acknowledge the limitations of this due to a small sample size and 
will take this into account when determining what additional covariates to adjust for. 
Additionally, a sensitivity analysis will be performed for all subjects who completed the week 5 
survey. 
Secondary and Exploratory Endpoint Analysis 
Secondary and exploratory endpoints will be analyzed using the same approach as the primary 
endpoint. These endpoints will be analyzed using an appropriate regression framework (i.e. 
linear, logistic, Poisson etc.), adjusting only for baseline measurements of the endpoint, if 
available, and the three stratification factors (rural/urban clinic, male/female gender and <50 
years of age/50+ years of age). Secondary analyses will consist of an adjusted analysis, as 

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described above. All analyses will utilize residual plots and other diagnostic statistics to 
evaluate all modeling assumptions.  
Measures of the ability to abstain from smoking (self-reported 24-hour, 7-day and 30-day 
abstinence) will be analyzed using a similar approach to the primary and secondary/exploratory 
endpoints, and summarized using a binary endpoint. Continuous 7-day biochemically-verified 
abstinence (saliva cotinine < 10 ng/mL8) will be summarized for those who self-reported 7-day 
abstinence prior to the week 5 survey, and analyzed using logistic regression, with a main effect 
for treatment group and adjustment of the stratification factors (rural/urban clinic, 
male/female gender and <50 years of age/50+ years of age). Because traditional tobacco 
(depending on the method of use and plants used) and secondhand smoke can increase saliva 
cotinine, additional analyses may be performed to explore their impact on biochemically-
confirmed abstinence. In addition, secondary analyses will consist of an adjusted analysis, as 
described in above. 
Subgroup Analysis 
No subgroup analyses will be performed due to small sample size. 
Missing Data 
An intent-to-treat analysis requires that subjects are analyzed according to their randomized 
treatment assignment, regardless of compliance to the study product, and that complete data 
are available on all study subjects. Every effort will be made to limit the amount of missing data 
in this trial, and study participants will be incentivized to partake in each study component, 
return the saliva sample, and complete all components.  
We will compare subjects with and without missing data in order to identify baseline covariates 
associated with missing data. All observed data will be utilized in the analyses, with missing 
data being assumed to be missing at random. Sensitivity analyses of the secondary/exploratory 
endpoints using multiple imputation may be considered depending on the amount of 
missingness. 
Interim Analyses 
No planned interim analyses. 
All statistical analyses will be performed by Katelyn Tessier from the Masonic Cancer Center, 
Biostatistics Core. 
15.2 Power Analysis:  
Our sample size is based on the primary outcome, frequency of app use initiated by the 
participant during the 5-week period. Using a two-sided, two-sample test for Poisson rates, a 
total of 116 participants (n=58 in the tailored group and n=58 in the non-tailored group) will 
allow us to achieve 80% power to detect a difference in frequency of app use between the 
groups of 3.15 assuming a rate of 35 (1 time per day over the 5 weeks) in the non-tailored 
group and an alpha of 0.05. This sample size is in alignment with other mHEALTH-related 
smoking cessation feasibility studies. 36, 50   
 
15.3 Statistical Analysis:  
See above.  

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15.4 Data Integrity:  
PI will periodically check for completeness as well as outliers or unusual values 
16.0 Health Information and Privacy Compliance 
16.1 
Select which of the following is applicable to your research: 
☒ My research does not require access to individual health information and therefore 
assert HIPAA does not apply.   
☐ I am requesting that all research participants sign a HIPCO approved HIPAA 
Disclosure Authorization to participate in the research (either the standalone form 
or the combined consent and HIPAA Authorization). 
☐ I am requesting the IRB to approve a Waiver or an alteration of research participant 
authorization to participate in the research. 
☐ An external IRB (e.g. Advarra) is reviewing and we are requesting use of the 
authorization language embedded in the template consent form in lieu of the U of 
M stand-alone HIPAA Authorization.  Note: External IRB must be serving as the 
privacy board for this option. 
16.2 
Identify the source of Private Health Information you will be using for your research 
(Check all that apply)   
☐ I will use the Informatics Consulting Services (ICS) available through CTSI (also 
referred to as the University's Information Exchange (IE) or data shelter) to pull 
records for me 
☒ I will collect information directly from research participants. 
☐ I will use University services to access and retrieve records from the Bone Marrow 
Transplant (BMPT) database, also known as the HSCT (Hematopoietic Stem Cell 
Transplant) database. 
☐ I will pull records directly from EPIC. 
☐ I will retrieve record directly from axiUm / MiPACS 
☐ I will receive data from the Center for Medicare/Medicaid Services  
☐ I will receive a limited data set from another institution  
☒ Other.  Describe: Other source of data is from the app which is managed by 
Smokefree.gov. This data will be identified with a unique participant ID. Thus, only 
de-identified data will transferred. 
16.3 
Explain how you will ensure that only records of patients who have agreed to have 
their information used for research will be reviewed. 
NA 
16.4 
Approximate number of records required for review: 
NA 

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16.5 
Please describe how you will communicate with research participants during the 
course of this research.  Check all applicable boxes 
☐ This research involves record review only. There will be no communication with 
research participants. 
☐ Communication with research participants will take place in the course of treatment, 
through MyChart, or other similar forms of communication used with patients 
receiving treatment.  
☒ Communication with research participants will take place outside of treatment 
settings. If this box is selected, please describe the type of communication and how 
it will be received by participants.  
 
Communication will take place by phone/text, email, and virtually. 
16.6 Explain how the research team has legitimate access to patients/potential participants:  
All participants will sign a consent form.  
16.7 Location(s) of storage, sharing and analysis of research data, including any links to 
research data (check all that apply).   
☐ In the data shelter of the Information Exchange (IE)  
 ☐ Store ☐ Analyze 
☐ Share 
☐ In the Bone Marrow Transplant (BMT) database, also known as the HSCT 
(Hematopoietic Stem Cell Transplant) Database  
 ☐ Store ☐ Analyze 
☐ Share 
☒ In REDCap (recap.ahc.umn.edu)  
 ☒ Store ☒ Analyze 
☒ Share 
☐ In Qualtrics (qualtrics.umn.edu) 
 ☐ Store ☐ Analyze 
☐ Share 
☐ In OnCore (oncore.umn.edu)  
 ☐ Store ☐ Analyze 
☐ Share 
☒ In the University’s Box Secure Storage (box.umn.edu) 
 ☒ Store ☒ Analyze 
☒ Share 
☒ In an AHC-IS supported server. Provide folder path, location of server and IT Support 
Contact: 
cancer.ahc.umn.edu\cancer\CancerCenter\Biostat\CCSG\Carroll, D\R21-AI and NCI 
QuitGuide\Data 
☒ Store ☒ Analyze 
☐ Share 
☒ In an AHC-IS supported desktop or laptop.  
Provide UMN device numbers of all devices: 20191709 

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 ☒ Store ☐ Analyze 
☐ Share 
☒ Other. Describe:  
Smokefree.gov will maintain de-identified participant app use data. This will be shared 
with the study team. Also, all de-identified saliva samples will be stored in a locked 
freezer overseen by the PI in Mayo 11th floor, Division of Environmental Health Sciences 
until shared with Masonic Cancer Center for analysis.  
Indicate if  data will be collected, downloaded, accessed, shared or stored using a server, 
desktop, laptop, external drive or mobile device (including a tablet computer such as an 
iPad or a smartform (iPhone or Android devices) that you have not already identified in 
the preceding questions 
☐I will use a server not previously listed to collect/download research data 
☒I will use a desktop or laptop not previously listed 
EnHS-M-DCLAP (supported through Environmental health Sciences, School of Public 
Health); No device number  
☐I will use an external hard drive or USB drive (“flash” or “thumb” drives) not previously 
listed  
☐I will use a mobile device such as an tablet or smartphone not previously listed 
16.8 Consultants. Vendors. Third Parties.  
We have a data use agreement with Smokefree.gov for collection and transfer of app 
user data. Please refer to the data use agreement included. 
We will have de-identified audio recordings from the interviews among a subset of the 
participants transcribed by a third party.  
16.9 Links to identifiable data:  
All identifiable information will either be paper documents, locked in the PI or project 
coordinator’s office in a locked cabinet, or in a folder on Box separate from study-related 
data. A link between the identifiable information and study-related data will be saved 
similarly. 
16.10 Sharing of Data with Research Team Members.  
All electronic data to be shared with research team will be identified by participant ID 
and/or app ID. Only those on the IRB or described in the consent form (i.e., 
Smokefree.gov) will have access to participant data.   
16.11 Storage of Documents:  
Participant saliva samples and electronic data will be stored until manuscripts are 
written. 
16.12 Disposal of Documents: We will maintain all consent forms as well as REDCap 
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State of Minnesota. After that paper documents will be shredded in paper shredder 
and REDCap and Smokefree.gov data will be archived/stored indefinitely.  
17.0 Confidentiality 
17.1 Data Security:  
All data is stored in one of the following secure systems: Box, REDCap, locked cabinet, locked 
freezer or the above mentioned AHC-IS supported biostat server.  
 
18.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
18.1 Data Integrity Monitoring.  
Oversight for quality control and adherence to protocol procedures will be conducted by Dr. 
Carroll. A start-up meeting with the investigative team and the research coordinator will occur 
prior to participant enrollment. During this meeting, Dr. Carroll will provide the research 
coordinator with training on the study protocol, standard operating procedures, equipment 
and data collection platforms. Dr. Carroll will closely monitor all procedures to be used in this 
study.  Such monitoring will consist of frequent in-person discussion with the research 
coordinator to make sure that all protocol procedures are followed, and regular phone 
meetings to provide updates on study progress and review the data collection process, and 
other issues of concern. 
Data will be collected in a consistent manner either through an interview with the research 
coordinator or via a REDCap survey that is completed by the participant.  
18.2 Data Safety Monitoring.  
N/A This study is considered not greater than minimal risk. 
19.0 Provisions to Protect the Privacy Interests of Participants 
19.1 Protecting Privacy:  
The coordinator will first ask the participant if they are in a safe place to complete the 
interviews and will refuse to conduct any interview if it is known that the participant is in an 
unsafe location or environment (e.g., driving a vehicle).  
All information from the study will be stored in a locked filing cabinet or password protected 
computer, and only the PI and key study personnel will have access. Participants will not be 
identified by name in any published report and will be given study specific numbers or false 
names. Participants will be told their participation will be strictly confidential that any 
identifying information will only be available to the research team. Participants will be told that 
tribal leaders and/or clinic leadership will determine if the Tribe/clinic is named or is 
anonymous in any publication or dissemination of the data. 
Each participant will be assigned a unique participant ID. All interview or survey data will be de-
identified and coded with their participant ID and stored in REDCap. The participants’ returned 
saliva sample will also be de-identified and coded with the participant ID. The key linking 
participant names to their participant ID will be stored in password protected BOX folder, and 
only the PI and key study personnel will have access to this document.  

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An App ID (different from their participant ID) will be entered into the app upon login for the 
first time. The App ID will also be stored in password protected BOX folder with access only 
provided to the IRB approved study team. The file in BOX will be the only way to link the app ID 
and the participant ID together and these IDs with their contact information. Other than dates, 
no PHI is collected by the app. Data collected from the participant using the GPS function in the 
app includes no physical locations just that it is a function being utilized by the user. 
19.2 Access to Participants:  
Participants will sign a consent giving access to the study team.  
20.0 Compensation for Research-Related Injury 
20.1 Compensation for Research-Related Injury: 
The study does not involve greater than minimal risk. However, the consent form includes 
standard not greater than minimal risk injury language.  
20.2 Contract Language:  
Not applicable. No contract.  
21.0 Consent Process 
21.1 Consent Process (when consent will be obtained):  
The consenting process will take place at the baseline visit prior to any data collection and 
randomization. During the consent process, participants will be provided with an opportunity 
to have their questions and concerns addressed. We will use an electronic informed consent 
process through REDCap. There is no waiting period necessary between signing consent and 
collection of data. 
21.2 Waiver or Alteration of Consent Process (when consent will not be obtained):  
No Waiver or Alteration of the Consent Process will be used for this study.  
21.3 Waiver of Written/Signed Documentation of Consent (when written/signed consent will 
not be obtained):  
No Waiver of Written/Signed Documentation of Consent will be used in this study.  
21.4 Non-English Speaking Participants:  
Participants who cannot speak or read English are excluded from the study because the 
QuitGuide app is currently only available in English.  
21.5 Participants Who Are Not Yet Adults (infants, children, teenagers under 18 years of age): 
This study will only enroll adults.  
21.6 Cognitively Impaired Adults, or adults with fluctuating or diminished capacity to consent: 
Individuals with cognitive impairments or with capacity to consent issues will not be enrolled.  
21.7 Adults Unable to Consent: 
All participants must be able to consent for themselves.  
22.0 Setting 

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22.1 Research Sites:  
The community partners include Native American Community Clinic (NACC), the Bad River Band 
Tribe in Wisconsin, and the American Indian Cancer Foundation (AICAF). See letters of support 
from NACC, Bad River Tribal leadership, and AICAF 
Potential participants will be recruited from NACC and the Bad River Band Tribe communities 
and their networks. These two partners are to be considered Research Locations only.  
AICAF will assist with study procedures and are to be considered a Research Site. All study-
related interactions will take place virtually. The interviewer will be in a private room when 
interacting with the participant virtually. We will ask all interviewees to locate a private room 
or one that they find suitable for the interview.  
Community partners helped develop the protocol. We will engage the communities through a 
Community Advisory Board (CAB) which includes community members (5-10) and stakeholders 
who are not participants. 
22.2 International Research:  
This is not international research.  
23.0 Multi-Site Research 
This study has two sites: University of Minnesota and AICAF. All sites will be submitted to the 
University of Minnesota as a single-IRB as required for federally-funded research.   
23.1 Study-Wide Number of Participants:  
  
Up to 126 will be consented.  
 
23.2 Study-Wide Recruitment Methods:  
All recruitment methods are as mentioned above.  
23.3 Study-Wide Recruitment Materials:  
All recruitment materials are as mentioned above.  
23.4 Communication Among Sites:  
Communications among sites will primarily take place by email but periodic meetings will also 
be scheduled as necessary. All currently-approved versions of documents will be available on 
Box and all site staff will have access to Box as a source-of-truth. All site staff will follow UMN’s 
security policies and other applicable guidelines. All IRB submission and reporting requirements 
will be completed using UMN’s IRB and communicated as necessary by UMN study staff.  
23.5 Communication to Sites:  
Communications to sites will primarily take place by email but periodic meetings will also be 
scheduled as necessary. 
24.0 Coordinating Center Research 

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Not applicable. This is not Coordinating Center research only.  
25.0 Resources Available 
25.1 Resources Available:  
We foresee the recruitment to be feasible based on previous studies within this population and 
with the same community partners.  
This project is funded by the NCI and has sufficient funding to be accomplished. Any additional, 
unforeseen, funding required will be covered by Dr. Carroll.  
Dr. Carroll, the PI, has sufficient resources to oversee this project and conduct human subjects 
procedures.  
The American Indian Cancer Foundation staff will assist with the human subjects components. 
If any individual from the community partners, who does not have their own IRB, is involved in 
any human subjects research, this individual will complete appropriate training (CITI through 
UMN) and be added to the IRB submission as study staff. 
26.0 References 
1. 
Forster J. Cigarette Smoking Among Urban American Indian Adults—Hennepin and Ramsey 
Counties, Minnesota, 2011. MMWR Morbidity and mortality weekly report. 2016;65. 
2. 
Martinez SA, Janitz AE, Erb-Alvarez J, Mowls DS, Campbell JE, Anderson T. Cancer among 
American Indians - Identifying Priority Areas in Oklahoma. J Okla State Med Assoc. 2016;109(7-
8):374-384. 
3. 
Mowls DS, Campbell JE, Beebe LA. Race and Gender Disparities in Lung Cancer Incidence Rates, 
2001-2010. In. Oklahoma State Medical Association: Univeristy of Oklahoma Health Sciences 
Center; 2015. 
4. 
American Cancer Society, the Minnesota Department of Health, Alliance. tMC. Minnesota 
Cancer Facts & Figures 2015. 2015. 
5. 
U.S. Department of Health and Human Services. Tobacco Use Among U.S. Racial/Ethnic 
Minority Groups—African Americans, American Indians and Alaska Natives, Asian Americans 
and Pacific Islanders, and Hispanics: A Report of the Surgeon General. Atlanta, Georgia: U.S.: 
Department of Health and Human Services, Centers for Disease Control and Prevention, 
National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and 
Health;1998. 
6. 
Forster JL, Skjefte L. Tribal Tobacco Use Project Survey Report: Findings from Minnesota 
American Indian Communities. 2013. 
7. 
Nez Henderson P, Kanekar S, Wen Y, et al. Patterns of cigarette smoking initiation in two 
culturally distinct American Indian tribes. Am J Public Health. 2009;99(11):2020-2025. 
8. 
Burgess D, Fu SS, Joseph AM, Hatsukami DK, Solomon J, van Ryn M. Beliefs and experiences 
regarding smoking cessation among American Indians. Nicotine Tob Res. 2007;9 Suppl 1:S19-28. 
9. 
Carroll DM, Soto C, Baezconde-Garbanati L, et al. Tobacco Industry Marketing Exposure and 
Commercial Tobacco Product Use Disparities among American Indians and Alaska Natives. 
Substance use & misuse. 2019:1-10. 
10. 
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