Wearable Device Intervention to Improve Sun Behaviors in Melanoma Survivors
Phase: NA
Conditions: Melanoma (Skin)
Sponsor: University of Minnesota

PROTOCOL TITLE: Wearable device intervention to improve sun behaviors in 
melanoma survivors 
VERSION DATE: 07/19/2021 
PROTOCOL COVER PAGE 
Protocol Title
Wearable device interven.on to improve sun behaviors in 
melanoma survivors
Principal 
Inves9gator/Faculty 
Advisor
Name: Rachel I. Vogel
Department: Obstetrics, Gynecology, and Women’s Health
Telephone Number: 612-624-6928
Email Address: isak0023@umn.edu
Scien9ﬁc 
Assessment
Cancer Protocol Review CommiTee (CPRC)
IND/IDE # (if 
applicable)
N/A
IND/IDE Holder
N/A
Inves9ga9onal Drug 
Services # (if 
applicable)
N/A
Version Number/
Date:
Version 3.2
 
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PROTOCOL TITLE: Wearable device intervention to improve sun behaviors in 
melanoma survivors 
VERSION DATE: 07/19/2021 
REVISION HISTORY 
Revision #
Version Date
Summary of Changes
Consent Change?
1
01/27/2020
This revision incorporates a number 
of changes. We have added an 
Appendix at the end of the protocol 
(following the references; page 47) 
which summarize these changes 
and the ra.onale for each change. 
 
Y
2
03/05/2020
We added the op.on to 
electronically sign the consent and 
HIPAA forms in REDCap given 
current COVID-19 health situa.on. 
Minor changes to exclusion criteria, 
recruitment, randomiza.on 
stra.ﬁca.on, and loTery 
procedures to accommodate 
requests from HealthPartners IRB.
N
3
05/08/2020
Clariﬁca.ons of changes in study 
enrollment process due to 
COVID-19, all materials ﬁnalized.
N
4
07/19/2021
Increase to number of people to be 
contacted/invited to par.cipate 
Increase recruitment planned 
numbers to align with ﬁnal 
recruitment numbers due to slightly 
higher than expected drop-out 
between verbal screening consent 
and wriTen consent; and between 
wriTen consent and baseline survey 
comple.on/randomiza.on. 
N
 
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PROTOCOL TITLE: Wearable device intervention to improve sun behaviors in 
melanoma survivors 
VERSION DATE: 07/19/2021 
 
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PROTOCOL TITLE: Wearable device intervention to improve sun behaviors in 
melanoma survivors 
VERSION DATE: 07/19/2021 
Table of Contents 
1.
Objectives 
 
................................................................................................................8
2.
Background 
 
..............................................................................................................8
3.
Study Endpoints/Events/Outcomes 
 
.......................................................................11
4.
Study Intervention 
 
.................................................................................................12
5.
Procedures Involved 
 
..............................................................................................15
6.
Data and Specimen Banking 
 
..................................................................................19
Self-administered questionnaire data will be collected at baseline, 4, 8, 12 and 64 weeks 
post-randomization (see Table 2 above). 
 
...........................................................................19
Demographics and Disease Information. Demographics will be ascertained at the baseline 
survey and will include age, race/ethnicity, income, education, employment status, 
relationship status, skin type and family history of cancer. Disease information will 
include disease stage, tumor location, treatments received and co-morbidities. 
 
...............19
Outcomes Measures. Outcomes will be measured via self-reported online surveys and the 
Shade device (see Section 3.0). Study outcomes include reliable and validated measures 
used previously by the study team and will be scored following standard procedures. 
 
....20
Process Measures. We will focus on a number of metrics regarding study implementation, 
including recruitment, compliance/engagement, retention, and satisfaction/usability of the 
device. Recruitment metrics will include a proportion of eligible individuals who agree to 
participate and number of contacts required to recruit a participant. Measures of 
compliance and engagement will focus on device set-up and intervention usage, including 
time from recruitment to device use, average number of days the device is worn per 
week, number of times the study coordinator contacted to remind use, and self-reported 
engagement/response to the UVR notifications on the mobile app. Study retention will be 
measured as the proportion of participants who complete the baseline and each of the 
follow-up surveys. Finally, we will measure satisfaction with the device. The 
implementation metrics will be examined after Wave 1 is complete in order to identify 
areas of opportunity to improve recruitment, compliance/engagement and retention that 
can be implemented prior to starting Wave 2. While we will keep the intervention 
consistent across Waves, we will consider alternative methods of recruitment, incentives, 
reminders, and other actions to maximize engagement and retention. 
 
..............................20
7.
Sharing of Results with Participants 
 
......................................................................20
8.
Study Population 
 
...................................................................................................20
9.
Vulnerable Populations 
 
..........................................................................................21
10.
Local Number of Participants 
 
................................................................................23
11.
Local Recruitment Methods 
 
..................................................................................23
12.
Withdrawal of Participants 
 
....................................................................................26
13.
Risks to Participants 
 
..............................................................................................26
14.
Potential Benefits to Participants 
 
...........................................................................27
15.
Statistical Considerations 
 
......................................................................................27
 
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PROTOCOL TITLE: Wearable device intervention to improve sun behaviors in 
melanoma survivors 
VERSION DATE: 07/19/2021 
All questionnaires have been previously developed and implemented and will be scored 
using standard methods. 
 
....................................................................................................27
Statistical analysis will focus on evaluating the efficacy, unintended consequences and 
implementation of the intervention in this RCT. The main analysis of the primary 
outcome (self-reported overall sun protection score) will be a two-sample two-sided two-
sample t-test comparing scores at the end of the intervention period (12 weeks) between 
intervention and control groups. Randomization should result in two groups that are 
similar for patient characteristics and other extraneous factors that may influence sun 
exposure and protection behaviors, however, we will compare the randomized groups by 
Wave, gender, age, stage of disease, device use (low/high), and baseline measures of sun 
protection and exposure behaviors using two-sample t-tests and Chi-squared tests to 
identify potential confounding factors which may not be balanced between the two 
groups. We will supplement the primary analysis with a multivariate linear regression 
model to account for any identified differences at baseline. A secondary analysis will 
explore changes in the sun protection score over the intervention period (baseline, weeks 
4, 8 and 12) using a mixed effects regression model. This analysis will not be completed 
until both Waves have been conducted. 
 
.............................................................................28
Secondary analyses will focus on each self-reported sun protection behavior separately, 
sunburns, intentional tanning, skin cancer knowledge, and physical activity and health 
behaviors by comparing the intervention and control participants over the study 
intervention period and 1 year post-completion. Analyses will be conducted using Chi-
squared and t-tests as appropriate for univariate analyses at each time point and logistic 
and linear regression models for multivariate analyses. Daily UVR data (minutes of UVR 
exposure per day) will be summarized using the area under the curve (AUC) over the 12 
week intervention period. Proper transformation (e.g. log-transformation) will be applied 
if the AUC data are skewed. The two groups’ AUC will be compared using similar 
methods as proposed above. The association between sun exposure and its potential 
moderating effect on sun protection behaviors during the intervention will be investigated 
using linear mixed effects models including main and interaction effects, adjusting for 
potential confounders. To address any potential intervention effects in the control group, 
we will compare the baseline and post-intervention sun protection behaviors scores using 
paired t-tests, stratifying by randomization group. The proportions of survivors in the 
intervention and control groups with potentially clinically significant depression and 
anxiety will be compared using Chi-squared tests and supplemented with multivariate 
logistic regression models. Finally, descriptive statistics will be used to summarize the 
implementation metrics both across and within randomization group both between Waves 
1 and 2 and after completion of the study. 
 
.........................................................................28
We plan to perform all primary statistical analyses following intention-to-treat (ITT) 
procedures. That is, all subjects allocated to a treatment or intervention will be followed 
up, evaluated, and analyzed as members of that group or treatment arm regardless of their 
compliance with the assigned treatment. While it is not expected that participants will be 
 
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PROTOCOL TITLE: Wearable device intervention to improve sun behaviors in 
melanoma survivors 
VERSION DATE: 07/19/2021 
incorrectly assigned, some may not use the device and certain features. For that reason, 
we will also summarize device use and consider sensitivity analyses exploring the 
intervention effect using per-protocol methods (incorporating device use) as opposed to 
ITT. A priori, we anticipate that the amount of use of the intervention will predict sun 
protection and exposure behaviors, though we will likely be underpowered for this 
analysis. 
 
.............................................................................................................................29
Every effort will be made to encourage participants’ compliance and data completeness. 
Nevertheless, we expect some amount of missing data. We plan to perform a 
comprehensive missing data analysis employing statistical methods that are valid under 
different missingness assumptions to determine if conclusions are sensitive to missing 
data. The primary missing data method will be multiple imputation using the Markov 
Chain Monte Carlo (MI-MCMC) method 36,37 assuming that data are missing at random
—that is, the probability that an observation is missing can depend on the observed data 
but not on the missing data. We will include appropriate baseline variables into the 
MCMC procedure to make the conditional independent missing assumption less 
stringent. If the treatment group is associated with missingness, we will conduct multiple 
imputation for each treatment group separately 38. The MI-MCMC method allows 
arbitrary missing patterns including intermittent missing and dropout. We will also 
perform a simple imputation analysis as a sensitivity analysis; specifically, the linear 
interpolation method will be used for intermittent missing (e.g., when people forget to 
charge or wear the device), while the last week average value carried forward method 
will be used for dropouts, assuming that the average of the last 7 days’ data will be a good 
estimate of the missing data. 
 
..............................................................................................29
16.
Confidentiality 
 
.......................................................................................................29
17.
Provisions to Monitor the Data to Ensure the Safety of Participants 
 
....................30
18.
Provisions to Protect the Privacy Interests of Participants 
 
....................................30
19.
Compensation for Research-Related Injury 
 
..........................................................31
20.
Consent Process 
 
.....................................................................................................31
21.
Setting 
 
....................................................................................................................32
22.
Multi-Site Research 
 
...............................................................................................32
N/A 
 
32
23.
Resources Available 
 
...............................................................................................32
24.
References .............................................................................................................48
 
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PROTOCOL TITLE: Wearable device intervention to improve sun behaviors in 
melanoma survivors 
VERSION DATE: 07/19/2021 
ABBREVIATIONS/DEFINITIONS 
•
AUC  
 
Area under the curve 
•
CESR 
 
Center for Evalua.on and Survey Research 
•
HIPAA 
 
Health Insurance Portability and Accountability Act 
•
ITT  
 
Inten.on-to-treat 
•
MI-MCMC  
Mul.ple imputa.on Markov Chain Monte Carlo 
•
QOL 
 
Quality of life 
•
UTAUT 
 
Uniﬁed Technology Acceptance and Use Theory 
•
UVR 
 
Ultraviolet radia.on 
 
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PROTOCOL TITLE: Wearable device intervention to improve sun behaviors in 
melanoma survivors 
VERSION DATE: 07/19/2021 
1.
Objec9ves 
1.1. Purpose:  
Our purpose is to improve sun protec.on behaviors and reduce sun 
exposure among melanoma survivors by increasing their awareness of 
ultraviolet radia.on (UVR) exposure by using a wearable UVR-sensor 
enabled technology device and corresponding mobile applica.on designed 
to reduce sun exposure and promote healthy sun protec.on habits. 
The Speciﬁc Aim of this study is to evaluate the eﬀec.veness of a UVR-
sensor wearable device interven.on to improve sun protec.on behaviors 
and reduce UV exposure and sunburns in a randomized controlled trial in 
melanoma survivors.  
2.
Background 
2.1. Signiﬁcance of Research Ques.on/Purpose:  
Melanoma, one of the most serious types of skin cancers, has been 
increasing in incidence over the past 30 years. With a 5-year survival rate of 
93%, there are currently over one million melanoma survivors in the United 
States 1. Melanoma is considered a generally preventable cancer, with 
excessive UVR exposure being one of the strongest risk factors for the 
disease 2,3. Pa.ents diagnosed with melanoma experience high rates of 
recurrence and second melanomas, with an approximately 9-fold increased 
risk of developing another melanoma 4. Pa.ents who recur or have a 
second melanoma diagnosis have signiﬁcantly worse prognosis 5,6. 
Importantly, UVR exposure following a melanoma diagnosis can be 
modiﬁed to reduce risk of a new melanoma diagnosis 7. Our recent study 
found that less than half of long-term melanoma survivors reported oien 
or always staying in the shade or wearing a hat, and 20% reported a 
sunburn in the past year 8. Therefore, while some melanoma survivors are 
repor.ng healthy UVR exposure and protec.on behaviors, opportuni.es 
clearly remain to reduce future melanoma risk in the majority of melanoma 
survivors. Therefore, it is the purpose of this study to implement an 
interven.on to promote healthy sun protec.on behaviors.  
2.2. Preliminary Data: 
Our preliminary data show the need for interven.on in this popula.on and 
highlight our extensive experience recrui.ng melanoma survivors, 
measuring sun exposure and protec.on behaviors in this popula.on, and 
using technology devices to change health behavior.  
 
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PROTOCOL TITLE: Wearable device intervention to improve sun behaviors in 
melanoma survivors 
VERSION DATE: 07/19/2021 
In 2009, we completed the Skin Health Study (NIH/NCI R01), a popula.on-
based case-control study to assess use of indoor tanning, life.me sun 
exposure, and use of sunscreen, sta.ns and NSAIDs in rela.on to 
melanoma. The study included men and women, ages 25-59 at diagnosis or 
reference date (for controls). Cases were diagnosed with a ﬁrst primary 
invasive melanoma between July 2004 and December 2007, iden.ﬁed by 
the Minnesota Cancer Surveillance System. Controls (individuals without 
melanoma) were randomly selected from the State’s driver license lists. A 
total of 1167 cases and 1101 controls completed a ques.onnaire about pre-
diagnosis exposure (or reference date for controls) for life.me exposure to 
solar and ar.ﬁcial UVR, skin, eye and hair color, freckles and moles, family 
history of skin cancer, life.me UVR exposure, sunburns, and sunscreen use. 
The study resulted in seven co-authored papers 9-15. 
We transi.oned from the 2009 study to a series of studies to document the 
long-term eﬀects of a melanoma diagnosis and treatment on survivors and 
compare their quality of life (QOL) and health behaviors with popula.on 
controls. First, a series of focus groups were conducted to describe the 
breadth of experiences among melanoma survivors, focusing on the 
experience at diagnosis, ongoing physical, emo.onal and social concerns, 
and behavioral changes since diagnosis 16. The focus groups included 33 
men and women diagnosed with Stage I-III cutaneous melanoma. 
Melanoma survivors par.cipa.ng in this study reported a diverse set of 
physical, emo.onal, and social concerns following diagnosis. They reported 
a high level of isola.on and loneliness, underscoring the need to increase 
both awareness of melanoma and chances for melanoma survivors to 
interact and support each other. Almost 80% reported worrying about their 
melanoma reoccurring or a new cancer developing. Interes.ngly, while 
many reported increased sun protec.on behaviors, some reported no 
changes and others felt as though they did not know which changes to 
make.  
Based on these data, a comprehensive ques.onnaire to address QOL issues 
and health behaviors of melanoma survivors was designed and tested. Then 
a cross-sec.onal study of melanoma survivors and popula.on controls was 
conducted. The goal was to collect data to evaluate the impact of 
melanoma on long-term survivorship focusing on quality of life 17 and sun 
exposure and protec.on behaviors 18. A total of 724 melanoma survivors 
and 660 controls from the parent study completed the survey. Melanoma 
survivors were diagnosed an average of 9.6 ± 1.0 years prior to comple.ng 
the survey; the majority (85.6%) had stage I disease, 6.4% had stage II 
 
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PROTOCOL TITLE: Wearable device intervention to improve sun behaviors in 
melanoma survivors 
VERSION DATE: 07/19/2021 
disease, 6.6% had stage III disease, and 1.4% had stage IV disease. The most 
common anatomic site of the tumor was the trunk (35.0%), followed by 
legs (26.9%), arms (26.4%), and head/neck (11.7%). Almost all (99.3%) had 
surgery and about one-third had lymph node dissec.on (34.8%).  
Melanoma survivors, compared to controls, reported sta.s.cally signiﬁcant 
but only slightly higher physical func.oning and bodily pain QOL subscale 
scores than controls and otherwise similar QOL as measured by the 
remaining six SF-36 subscale scores 17. Prevalence of anxiety and 
depression were similar between melanoma survivors and controls. 
Our data regarding sun exposure and protec.on behaviors indicated that 
long-term survivors of melanoma reported greater use of sun protec.on 
behaviors than controls 8. Par.cularly important to this applica.on, 
however, was the signiﬁcant subgroup of melanoma survivors (20%) who 
experienced sunburn in the past year, reported inten.onal tanning (10%), 
did not wear a hat (67%) or stay in the shade (52%), and spent more than 
two hours in the sun on weekends (75%), punng them at elevated risk for 
future melanomas (Figure 1).  
In addi.on to our exper.se on melanoma survivors and sun protec.on, we 
also have conducted research in using technology to change behavior. In 
two large-scale federally funded research studies of physical ac.vity 
(R01AG023410, R01-HL072947), and one large-scale federally funded study 
of weight-loss maintenance (R01-CA128211), collaborator B.C. Mar.nson 
employed electronic devices in the form of accelerometer-based ac.graphy 
monitors for collec.on of objec.ve measures of physical ac.vity. He served 
 
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PROTOCOL TITLE: Wearable device intervention to improve sun behaviors in 
melanoma survivors 
VERSION DATE: 07/19/2021 
as Co-Inves.gator on an industry-funded pilot project using Internet-
enabled scales as weight monitoring and feedback devices to foster 
behavior change to support healthy weight loss (“Weigh By Day Pilot 
Study,” PI: Nico Pronk). The experience gained from these studies in 
overcoming challenges associated with the distribu.on to, and training of 
par.cipants in the use of electronic monitoring devices, as well as data 
collected, data summariza.on and repor.ng will ensure the successful use 
of monitoring devices in the proposed study. 
2.3. Exis.ng Literature: 
Previously, no interven.ons to promote healthy sun protec.on behaviors 
have been studied in melanoma survivors. Prior studies have typically 
focused on individuals at moderate to high risk of developing skin cancer 
but not melanoma survivors 19-21. One model for behavior change that has 
been eﬀec.ve in other areas of preven.ve health is the Fogg Behavior 
Model 22. According to this model, the drivers of behavior are: 1) 
mo.va.on, 2) ability, and 3) triggers. Technology can be a useful tool to 
implement these drivers. New wearable technologies, which fall under the 
umbrella of ecological momentary interven.ons, incorporate UVR sensors 
to track exposure in addi.on to tracking other behaviors such as physical 
ac.vity. This technology may be an important addi.on to melanoma 
preven.on because prior exercise and ac.vity interven.ons have not 
addressed sun exposure and protec.on and a recent analysis of na.onal 
U.S. data suggest that higher physical ac.vity is associated with sunburn 23.  
3.
Study Endpoints/Events/Outcomes 
3.1. Primary Outcome:  
Sun protec.on habits index, measured using Glanz et al., 2008 
ques.onnaire, will be scored by taking the average of 6 protec.ve 
behaviors (wearing a shirt with sleeves, wearing sunglasses, staying in the 
shade, using sunscreen, limi.ng .me in the sun, and wearing a hat) on a 4-
point ordinal scale ranging from 1 = rarely or never to 4 = always. This has 
been used previously in similar interven.on studies 19 
3.2. Secondary Outcomes:  
•
Sunburn during the interven.on period 
•
Each sun protec.on behavior separately 
•
Sun/UVR exposure (The device will provide objec.ve measures of daily 
UVR exposure) 
 
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PROTOCOL TITLE: Wearable device intervention to improve sun behaviors in 
melanoma survivors 
VERSION DATE: 07/19/2021 
•
Sun protec.on knowledge 
•
Unintended Consequences: we will measure physical ac.vity, depression 
and anxiety to examine the poten.al unintended nega.ve consequences 
of the interven.on. Self-reported physical ac.vity, along with other 
healthy behaviors such as fruit and vegetable consump.on, will be 
ascertained using the American Health Associa.on’s Life’s Simple 7 24. 
Depression and anxiety will be measured using the Hospital Anxiety and 
Depression Scale (HADS) 25.  
4.
Study Interven9on 
4.1. Conceptual Model and Descrip.on: 
We are adop.ng the Fogg Behavioral Model 26 as our theore.cal guide for 
this interven.on, as depicted in the conceptual framework chart (Figure 2). 
Following the Fogg Behavioral Model, we will address barriers, examine 
mo.vators, and provide appropriate triggers to encourage op.mal sun 
protec.on behaviors in melanoma survivors. The interven.on will iden.fy 
individual barriers that prevent melanoma survivors from op.mal sun 
protec.on behaviors and then use messages (through website/brochure) to 
reduce perceived barriers and increase mo.va.on to change. When people 
are highly mo.vated to change behavior and have the means to conduct 
the goal behavior, triggers are employed to prompt ac.on; here, triggers 
would be messages regarding sun protec.on and exposure delivered via 
the wearable device as it detects UVR exposure.  
 
 
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Figure 2 Conceptual Framework of the Study

PROTOCOL TITLE: Wearable device intervention to improve sun behaviors in 
melanoma survivors 
VERSION DATE: 07/19/2021 
Interven.on Components: 
We propose to use a wearable device that monitors UVR exposure to 
promote op.mal sun protec.on behaviors. This interven.on was chosen 
instead of an informa.on-only website or mobile applica.on because while 
knowledge is one component of behavior change, the interven.on should 
address barriers, provide mo.vators and more importantly triggers to 
ul.mately change behavior. In conjunc.on with the device and its 
associated mobile applica.on, we will also develop a website that will 
provide informa.on about the importance of UVR avoidance and 
protec.on in the popula.on, in addi.on to suppor.ng other health 
behaviors. Both interven.on components will be provided to study 
par.cipants randomized to the interven.on group; the control group will 
received modiﬁed versions of each component. 
(1). UVR-sensor enabled wearable band. We will provide a UVR-sensor 
enabled wrist wearable device to all par.cipants. Shade, 2nd genera.on, 
was developed in collabora.on with the NIH Na.onal Cancer Ins.tute. The 
researchers who developed this device have shown its UVR measurements 
to be signiﬁcantly more accurate than other similar devices 27 and 
melanoma survivors reported it was easy to use.28 In addi.on to accurately 
measuring UVR exposure in a manner that does not rely on self-report and 
memory, Shade includes a mobile app that helps users set daily limits that 
take into account UVR intensity, .me of exposure, and sunscreen 
applica.on. Importantly, the app and device provide prompts when 
approaching the daily limit. The device will alert par.cipants once they 
reach 20% of their daily limit (and every 20% aier that) via a no.ﬁca.on on 
the par.cipant’s phone. It will also prompt them in the morning to put the 
device on and in the evening to place it on the charger. 
(2). Informa.onal Website. An organized library of informa.on on 
melanoma and numerous health behaviors, including physical ac.vity and 
sun exposure and protec.on, will be provided to par.cipants in both 
groups. Par.cipants will be sent a link to the website following comple.on 
of the online surveys during the interven.on period. We will also include 
messaging based reported barriers to op.mize sun protec.on (example 
messaging provided in Table 1) for those in the interven.on group via the 
website and as a printed brochure which will be provided at baseline. The 
messaging will be pre-tested. While it has been widely reported that health 
educa.on alone is insuﬃcient to promote behavior change, a recent review 
of skin cancer knowledge and sun-related behaviors found that the 
majority of studies reported a posi.ve associa.on between sun protec.on 
behaviors and knowledge.29 Interes.ngly, however, the data did not 
 
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PROTOCOL TITLE: Wearable device intervention to improve sun behaviors in 
melanoma survivors 
VERSION DATE: 07/19/2021 
support a rela.onship between knowledge and less tanning or sun 
exposure.  
Control Group. The control group will be oﬀered both components (device 
and informa.onal website), however, they will be provided a version of the 
mobile app that only collects the UVR exposure and does not provide 
no.ﬁca.ons as they reach daily limits or summary informa.on about 
exposure. The controls will also be provided basic informa.on on sun 
exposure and protec.on recommenda.ons as part of the website, however 
they will not receive the messaging regarding barriers. The aTen.on-
control group was chosen over no interven.on for a few reasons; one, we 
Table 1. Example messages to address perceived barriers to sun protec9on
Perceived Barrier 
Educa9onal Message
Ac9on Message
“I want to be/look 
tan because it is 
more aTrac.ve.”
The sun causes more than 90 
percent of the visible changes 
commonly aTributed to skin 
i
30
Think about the feelings you 
associate with being tan? Are there 
other ways to generate those 
f
li
ith
t t
i
?
“I feel lei out if 
I’m not in the sun 
with my friends/
family.”
People diagnosed with 
melanoma are at an 
approximately 9-fold increased 
risk of developing another 
melanoma 4. However, UVR 
exposure following a melanoma 
diagnosis can be modiﬁed to 
d
i k f
l
Find an opportunity to educate your 
friends on melanoma and the 
importance of sun avoidance and 
protec.on for everyone. You may 
also consider a self-tanner or 
tanning lo.on to make your skin 
look tanner.
“I worry about 
maintaining 
healthy levels of 
Vit
i D ”
The safest way to obtain vitamin 
D is through diet and 
supplements.
Check your Vitamin D levels on an 
annual basis and use supplements as 
directed by your provider.
“I don’t like the 
feel of sunscreen. 
And it is expensive 
anyway.”
The most eﬀec.ve sun protec.on 
methods are seeking shade and 
covering up. 
Try a few alterna.ve products to see 
if you can ﬁnd one that has an 
acceptable texture and/or fragrance. 
You could also consider covering up 
with a hat or clothing instead.
“I don’t think the 
sun is what 
caused my 
l
”
Approximately 86% of 
melanomas can be aTributed to 
exposure to UVR from the sun 31.
Speak with your dermatologist about 
ways you can reduce your risk for 
recurrence.
“I’m too old for it 
to maTer, I’m 
paying for things I 
did
kid ”
Contrary to popular belief, only 
about 23 percent of life.me 
exposure occurs by age 18 32.
Set an example for younger people 
in your life by avoiding and 
protec.ng yourself from the sun.
“I forget about it 
as my diagnosis 
gets further in the 
t ”
The risks for a new melanoma 
aier an ini.al diagnosis can 
con.nue for up to 20 years 4. 
Make sun protec.on rou.ne. For 
example, use a daily face or body 
lo.on with SPF protec.on.
 
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PROTOCOL TITLE: Wearable device intervention to improve sun behaviors in 
melanoma survivors 
VERSION DATE: 07/19/2021 
can objec.vely measure UVR exposure in both groups; two, providing the 
device to the control group will help with recruitment, engagement and 
reten.on.  
4.2. Drug/Device Handling: 
The proposed research involves the use of a commercially-available 
environmental tracker for UV exposure. It is not a medical device.   
4.3. Biosafety: N/A  
4.4. Stem Cells: N/A 
5.
Procedures Involved 
5.1. Study Design:  
The RCT among 368 eligible melanoma survivors will be conducted in two 
Waves (two consecu.ve summers), with planned adjustments to improve 
recruitment, compliance and par.cipant reten.on between study Waves, 
see Figure 3. Wave 1 may enroll up to 184 par.cipants, though given 
logis.cal constraints due to working from home during the pandemic, 
fewer may be recruited, with the plan to obtain the full 368 by the end of 
Wave 2. 
 
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Figure 3. Phase 2 Study Design.

PROTOCOL TITLE: Wearable device intervention to improve sun behaviors in 
melanoma survivors 
VERSION DATE: 07/19/2021 
 
5.2. Study Procedures –Randomized Controlled Trial:  
Randomiza*on. Following wriTen consent and comple.on of the baseline 
survey, par.cipants will be randomized with a 1:1 ra.o to the interven.on 
or control arm. Randomiza.on will be stra.ﬁed by age (<50 years, 50+ 
years), gender, years since melanoma diagnosis (<2 years, 2-5 years, 6-9 
years) and highest melanoma stage (I, II, III/IV). We will use block 
randomiza.on with random blocks of size 2 and 4 to improve balance. The 
staﬀ recrui.ng and enrolling par.cipants will be blinded to their 
randomiza.on. The study sta.s.cian will use R to generate random 
sequence numbers based on the stra.ﬁed, block randomiza.on scheme 
and upload the alloca.on list to REDCap. Following consent and screening, 
the study coordinator at the University of Minnesota will randomize 
par.cipants.  
Study Ini*a*on. Following randomiza.on, par.cipants will then be mailed 
their device in early summer (with appropriate version of the mobile app 
based on randomiza.on) and study assigned log-in informa.on. This will 
include a study-created user name to be used with the device/mobile app 
to allow for direct retrieval of the device-collected data by the study 
coordinator. Par.cipants will also be provided wriTen training materials. 
Par.cipants will be provided with a study phone number and email to 
contact the study coordinator with any remaining technical issues or 
ques.ons.  
 
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PROTOCOL TITLE: Wearable device intervention to improve sun behaviors in 
melanoma survivors 
VERSION DATE: 07/19/2021 
Study Procedures. Users will be asked to wear the devices and sync it with 
the mobile app every day for 12 weeks, regardless of planned physical or 
outdoor ac.vi.es. The study coordinator will view the data of all 
par.cipants (both interven.on and control) weekly to monitor device use. 
The study coordinator will contact par.cipants who do not use their device 
more than 3 days in any given week to determine barriers and encourage 
use. Par.cipants will be asked to complete periodic surveys and return the 
device via mail at the end of the interven.on period. 
Data Collec*on. Study measures will be collected via online surveys (in 
REDCap 33) and the Shade device. The survey will be accessible anywhere 
with an internet connec.on, see sec.on 6.0. Self-administered 
ques.onnaire data will be collected at the start of the interven.on (week 
0), week 4, week 8 and week 12 (end of interven.on), and week 64 (1 year 
aier the end of the interven.on; the end of the following summer). Aier 
comple.ng the surveys, par.cipants will be directed to the study website. 
Survey measures and their purpose are detailed in Table 2. 
Table 2. Study Measures.
Weeks
Measure
Purpose
Description
# 
Items
0
4
8
12
64
Health 
behaviors
Distraction 
Measures of healthy 
behaviors, including 
alcohol, smoking, fruits, 
vegetables, vitamin D, 
height, weight
10
X
X
X
X
X
Physical 
activity
Secondary 
outcome 
(unintended 
consequence)
Strenuous, moderate and 
mild activity times per 
week and amount of time 
per session
6
X
X
X
X
X
Sun Protection 
Habits 
Primary 
outcome
Use of sunscreen, hat, shirt 
and shade while in the sun; 
Likert scale
14
X*
X*
X*
X*
X*
Sunburns
Secondary 
outcome 
(efficacy)
How many times did you 
have a red OR painful 
sunburn that lasted a day 
or more?
1
X**
X*
X*
X*,**
X**
Sun Exposure 
and other 
Protection 
measures
Validation/ 
Comparison 
with device 
data
Exposure during weekday 
and weekend days, 
sunscreen details, indoor 
tanning 
11
X**
X*
X*
X*
X**
 
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PROTOCOL TITLE: Wearable device intervention to improve sun behaviors in 
melanoma survivors 
VERSION DATE: 07/19/2021 
* Time frame: past 4 weeks       ** Time frame: past summer 
5.3. Study Dura.on: 
While the en.re study will take approximately 4 years in total, each 
par.cipant will only be enrolled for a liTle longer than 1 year (12-week 
interven.on implementa.on period, and follow up survey at 64-weeks). 
5.4. Individually Iden.ﬁable Health Informa.on: 
HealthPartners will obtain pa.ent name, address, email address, and 
telephone number based on melanoma diagnosis to contact poten.ally 
eligible par.cipants. Among those who agree to par.cipate in the study, we 
will obtain signed Health Insurance Portability and Accountability Act 
(HIPAA) authoriza.on forms to seek data from HealthPartners and store 
Beliefs, 
Intentions, 
Self-Efficacy 
regarding sun 
protection 
behaviors 
Substudy (if 
intervention 
fails)
Reasoned Action Battery: 
Intention, Attitude, 
Behavioral beliefs, 
Normative pressure, 
Normative beliefs, Self-
efficacy
84
X
X 
(60)
X 
(60)
Sun protection 
knowledge 
Secondary 
outcome 
(efficacy)
Knowledge of sun 
protection (items covered 
in brochure) 
6
X
X
X
Hospital 
Anxiety and 
Depression 
Scale 
Secondary 
outcome 
(unintended 
consequence)
Screener for depression 
and anxiety used 
frequently in cancer 
survivors; Likert scale
14
X
X
X
Comorbidities
Background
14
X
X
X
Diagnosis and 
treatment
Background/ 
Potential 
moderators
Year diagnosis, location, 
stage, treatments received, 
recurrence, metastasis
18
X
Fear of 
recurrence
Background/ 
Potential 
moderator
Cancer and health worry
5
X
X
X
Demographics
Background/ 
Potential 
moderators
Sex, age, race/ethnicity, 
education, income, marital 
status, parent status, 
family history of cancer, 
skin phenotype
15
X
Device use
9
X
X
X
Device 
satisfaction
17
X
Total number of items
198
51
51
167
141
 
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PROTOCOL TITLE: Wearable device intervention to improve sun behaviors in 
melanoma survivors 
VERSION DATE: 07/19/2021 
informa.on regarding their melanoma diagnosis, including date of 
diagnosis and disease stage.  These data will supplement the self-reported 
data.  
5.5. Use of radia.on: N/A 
5.6. Use of Center for Magne.c Resonance Research: N/A 
6.
Data and Specimen Banking 
6.1. Storage and Access 
All data (collected by the wearable device and survey data) will be stored in 
REDCap includes features to support HIPAA compliance with a full audit 
trail, user-based privileges, and integra.on with the ins.tu.onal LDAP 
server. Only members of the research team will have access to the data. 
Data collected by the wearable devices: The study coordinator will use the 
study user names to access the device use data via the Shade clinical trials 
dashboard. The data are maintained de-iden.ﬁed (study user ID only) 
indeﬁnitely as part of the Shade dashboard and can be exported as a CSV or 
Excel ﬁle. The study coordinator will view the data of all par.cipants (both 
interven.on and control) weekly to monitor device use. Following the 
comple.on of the interven.on period, the study coordinator will download 
the ﬁnal device data which will be combined and merged with the REDCap 
survey data for sta.s.cal analysis. 
Survey data:  Survey data will be collected and stored in REDCap 33. The 
study survey will be accessible from any loca.on with an internet 
connec.on. REDCap allows users to exit and return to the survey at any 
.me without losing data. As the par.cipant completes the ques.onnaire, 
the data are entered directly into the REDCap database, which uses a 
MySQL database via a secure web interface with data checks to ensure data 
quality.  
6.2. Data:  
Self-administered ques.onnaire data will be collected at baseline, 4, 8, 12 
and 64 weeks post-randomiza.on (see Table 2 above).  
Demographics and Disease Informa.on. Demographics will be ascertained 
at the baseline survey and will include age, race/ethnicity, income, 
educa.on, employment status, rela.onship status, skin type and family 
history of cancer. Disease informa.on will include disease stage, tumor 
loca.on, treatments received and co-morbidi.es.  
 
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PROTOCOL TITLE: Wearable device intervention to improve sun behaviors in 
melanoma survivors 
VERSION DATE: 07/19/2021 
Outcomes Measures. Outcomes will be measured via self-reported online 
surveys and the Shade device (see Sec.on 3.0). Study outcomes include 
reliable and validated measures used previously by the study team and will 
be scored following standard procedures.  
Process Measures. We will focus on a number of metrics regarding study 
implementa.on, including recruitment, compliance/engagement, 
reten.on, and sa.sfac.on/usability of the device. Recruitment metrics will 
include a propor.on of eligible individuals who agree to par.cipate and 
number of contacts required to recruit a par.cipant. Measures of 
compliance and engagement will focus on device set-up and interven.on 
usage, including .me from recruitment to device use, average number of 
days the device is worn per week, number of .mes the study coordinator 
contacted to remind use, and self-reported engagement/response to the 
UVR no.ﬁca.ons on the mobile app. Study reten.on will be measured as 
the propor.on of par.cipants who complete the baseline and each of the 
follow-up surveys. Finally, we will measure sa.sfac.on with the device. The 
implementa.on metrics will be examined aier Wave 1 is complete in order 
to iden.fy areas of opportunity to improve recruitment, compliance/
engagement and reten.on that can be implemented prior to star.ng Wave 
2. While we will keep the interven.on consistent across Waves, we will 
consider alterna.ve methods of recruitment, incen.ves, reminders, and 
other ac.ons to maximize engagement and reten.on. 
6.3. Release/Sharing 
Data collected in this study will not be released or shared to those outside 
of the research team. 
7.
Sharing of Results with Par9cipants 
7.1. All par.cipants (regardless of randomiza.on group) will be provided a 
summary report of their personal sun exposure during the interven.on 
period. Study results will be not be shared with the par.cipants nor will 
study par.cipa.on be shared with their providers. Par.cipants will have 
access to their own data captured by the device via their mobile 
applica.on. 
8.
Study Popula9on 
8.1. Inclusion Criteria: 
• 18-75 years old 
 
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PROTOCOL TITLE: Wearable device intervention to improve sun behaviors in 
melanoma survivors 
VERSION DATE: 07/19/2021 
• Diagnosed with cutaneous invasive melanoma within 
HealthPartners system since 2010  
• Able to read/write in English 
• Own a smartphone 
• Able to provide voluntary informed consent 
8.2. Exclusion Criteria: 
• Inability to  provide informed consent 
• Pregnancy 
• Pa.ents who have opted out of their records being used for 
research purposes 
8.3. Screening: 
To iden.fy eligible par.cipants, HealthPartners medical claims 
data will be queried to iden.fy members diagnosed with 
melanoma during the recruitment eligibility period (2010-
forward). HealthPartners members who have a melanoma 
diagnosis (2 or more codes) between 2010 and the beginning of 
the study recruitment period will be queried from the VDW or 
ADW Administra.ve Claims database. If addi.onal subjects need 
to be iden.ﬁed to meet recruitment goals, then HealthPartners or 
Park Nicollet pa.ents who are not HealthPartners members will 
be queried from EMR data in the EPIC/Clarity database. ICD9 and 
ICD10 Codes of 172.xx and C43.xxx respec.vely will be used to 
iden.fy eligible members or pa.ents. Tumor registry data within 
the VDW may also be u.lized to iden.fy members or pa.ents 
diagnosed with melanoma.  Those iden.ﬁed as poten.ally eligible 
will be mailed an invita.on leTer from HealthPartners and 
contacted by phone to conﬁrm eligibility. 
    
9.
Vulnerable Popula9ons 
9.1. Vulnerable Popula.ons: 
Popula.on / Group
Iden.fy whether any of the 
following popula.ons will be 
targeted, included (not necessarily 
targeted) or excluded from 
par.cipa.on in the study. 
 
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PROTOCOL TITLE: Wearable device intervention to improve sun behaviors in 
melanoma survivors 
VERSION DATE: 07/19/2021 
Children
Excluded from Par.cipa.on
Pregnant women/fetuses/neonates
Excluded from Par.cipa.on
Prisoners
Excluded from Par.cipa.on
Adults lacking capacity to consent 
and/or adults with diminished 
capacity to consent, including, but 
not limited to, those with acute 
medical condi.ons, psychiatric 
disorders, neurologic disorders, 
developmental disorders, and 
behavioral disorders
Excluded from Par.cipa.on
Non-English speakers
Excluded from Par.cipa.on
Those unable to read (illiterate)
Excluded from Par.cipa.on
Employees of the researcher
Excluded from Par.cipa.on
Students of the researcher
Excluded from Par.cipa.on
Undervalued or disenfranchised 
social group
Included/Allowed to Par.cipate
Ac.ve members of the military 
(service members), DoD personnel 
(including civilian employees)
Included/Allowed to Par.cipate
Individual or group that is 
approached for par.cipa.on in 
research during a stressful situa.on 
such as emergency room senng, 
childbirth (labor), etc.
Excluded from Par.cipa.on
Individual or group that is 
disadvantaged in the distribu.on of 
social goods and services such as 
income, housing, or healthcare.
Included/Allowed to Par.cipate
Individual or group with a serious 
health condi.on for which there are 
no sa.sfactory standard treatments.
Included/Allowed to Par.cipate
 
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PROTOCOL TITLE: Wearable device intervention to improve sun behaviors in 
melanoma survivors 
VERSION DATE: 07/19/2021 
9.2. Addi.onal Safeguards: 
All par.cipants will have had a melanoma diagnosis, which is a serious 
health condi.on. This study speciﬁcally aims to understand and intervene 
on sun risk behaviors among melanoma survivors. Therefore, melanoma 
survivors are the explicit target popula.on of this study.  
The proposed research will not speciﬁcally seek military members or DOD 
personnel, disadvantaged individuals or members of undervalued or 
disenfranchised social groups, however, if volunteers meets the inclusion 
criteria and also happen to be from one of the groups checked above, they 
will be eligible to par.cipate in the study.  
10.
Local Number of Par9cipants 
10.1. Local Number of Par.cipants to be Consented as Eligible for Recruitment 
(Verbal): 460  
Local Number of Par.cipants to be Consented to Full Study (WriTen): 390  
11.
Local Recruitment Methods 
11.1. Recruitment Process: 
Trained and experienced staﬀ of HealthPartners Ins.tute Center for 
Evalua.on and Survey Research (CESR) will oversee the recruitment 
process. The CESR has been engaged in research both within the 
HealthPartners pa.ent/member popula.on and broader community for 
more than 15 years and is directed by a seasoned PhD survey 
methodologist and health services researcher, who oversees staﬀ of 
Individual or group with a fear of 
nega.ve consequences for not 
par.cipa.ng in the research (e.g. 
ins.tu.onaliza.on, deporta.on, 
disclosure of s.gma.zing behavior).
Excluded from Par.cipa.on
Any other circumstance/dynamic 
that could increase vulnerability to 
coercion or exploita.on that might 
inﬂuence consent to research or 
decision to con.nue in research.
Excluded from Par.cipa.on
 
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PROTOCOL TITLE: Wearable device intervention to improve sun behaviors in 
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VERSION DATE: 07/19/2021 
bachelors and masters-level employees with experience and training in 
survey, interview, chart-audit, and electronic data capture for research 
purposes. The CESR employs REDCap (Research Electronic Data Capture) 33 
as a primary data capture and management plaxorm. 
To recruit the required sample size and ensure meaningful measures of 
protec.on sun exposure, par.cipants will be enrolled in two cohorts (Wave 
1 and 2) over two consecu.ve summers. Recruitment will occur in the 
spring with the study interven.on running over the summer both years to 
account for seasonality.  
Poten.al par.cipants iden.ﬁed by HealthPartners in the screening process 
will be randomly assigned to a mailing round (2 rounds of approximately 
n=500 each within each Wave). Each round will be mailed 2 weeks apart to 
ensure phone contact is proximal to the mail date. We will send poten.al 
subjects a leTer on HealthPartners leTerhead introducing the general 
nature of the study and the elements of informed consent, and no.fying 
the par.cipant that a study interviewer will soon call. Subjects will be 
provided a study phone-number, which they may contact if they would like 
more informa.on about the study. The leTer will state that the informa.on 
obtained is conﬁden.al and that par.cipa.on is voluntary. Next, within two 
weeks of sending each leTer, an interviewer trained speciﬁcally on this 
study protocol will phone the subject to ask if he or she is willing to 
par.cipate in the study if they have not opted out. The interviewer will 
obtain verbal consent to par.cipate in the study and for their contact 
informa.on (name, address, phone number) to be shared with members of 
the University of Minnesota research staﬀ. If such consent is provided, it 
will be documented and their names and contact informa.on will be so 
forwarded.  All subsequent contact with these individuals in conjunc.on 
with this study will be conducted by study staﬀ at the University of 
Minnesota 
Once the goal of consen.ng par.cipants has been reached for a given 
Wave, a wait-list will be created which will be used to replace individuals 
who do not complete the formal study consent process and baseline 
survey.  Given our expecta.on of losing approximately 15% of individuals 
aier this ini.al agreement, HealthPartners will provide the University of 
Minnesota with contact informa.on for addi.onal individuals. 
The University of Minnesota staﬀ will then contact individuals provided by 
HealthPartners by mail or email in spring to conﬁrm their interest in 
par.cipa.ng in the study and obtain wriTen or electronic informed consent 
and HIPAA forms along with their preferred form of contact for study 
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PROTOCOL TITLE: Wearable device intervention to improve sun behaviors in 
melanoma survivors 
VERSION DATE: 07/19/2021 
11.2. Iden.ﬁca.on of Poten.al Par.cipants: 
To iden.fy eligible par.cipants, HealthPartners medical claims data will be 
queried to iden.fy members diagnosed with melanoma during the 
recruitment eligibility period (2010-forward). HealthPartners members who 
have a melanoma diagnosis (2 or more codes) between 2010 and the 
beginning of the study recruitment period will be queried from the VDW or 
ADW Administra.ve Claims database. If addi.onal subjects need to be 
iden.ﬁed to meet recruitment goals, then HealthPartners or Park Nicollet 
pa.ents who are not HealthPartners members will be queried from EMR 
data in the EPIC/Clarity database. ICD9 and ICD10 Codes of 172.xx and 
C43.xxx respec.vely will be used to iden.fy eligible members or pa.ents. 
Tumor registry data within the VDW may also be u.lized to iden.fy 
members or pa.ents diagnosed with melanoma. HealthPartners will be the 
only site of recruitment.  
11.3. Recruitment Materials: 
Par.cipants will be mailed an introductory leTer outlining the study 
purpose and providing an email address / phone number to contact the 
study coordinator if interested.  HealthPartners will then follow-up by 
phone to obtain verbal consent to provide their contact informa.on to the 
University of Minnesota. The University of Minnesota when then mail or 
email individuals an introductory leTer and either paper consent and HIPAA 
forms (mail) or a link to access online consent and HIPAA forms.  All 
recruitment materials are provided with the protocol.   
11.4. Payment: 
Par.cipants will be provided gii cards by mail throughout the study period 
as they complete study procedures.  They will receive $20 following 
comple.on of the baseline survey, $10 for the week 4 survey, $10 for the 
week 8 survey, $60 for returning the device at the end of the study period 
and comple.ng the week 12 survey, and $20 for the week 64 survey (for a 
total of up to $120). In addi.on, a loTery-based incen.ve will be used to 
promote adherence. This incen.ve structure will indirectly support 
behavior change by incen.vizing use of the devices rather than directly 
incen.vizing the direct sun-exposure behavior. Par.cipants will be entered 
into weekly loTeries for $100 gii cards for the dura.on of the interven.on 
period (12 weeks; loTeries will be held up to 16 weeks given the rolling 
recruitment). The weekly winners will be randomly drawn from all 
par.cipants. The randomly selected winners will only be eligible for the 
prize if they wore the device at least 5 days during that week, as evidenced 
by ac.vity data. We will email the study group every week indica.ng that 
 
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PROTOCOL TITLE: Wearable device intervention to improve sun behaviors in 
melanoma survivors 
VERSION DATE: 07/19/2021 
the loTery was drawn, a winner was chosen, and the number of draws 
required to obtain a par.cipant who was eligible to win.  
12.
Withdrawal of Par9cipants 
12.1. Withdrawal Circumstances:  
No par.cipant will be withdrawn from the study against their will. 
Par.cipants will only be withdrawn from the study if they ask to withdraw 
or become too ill or die prior to comple.ng the study.  If par.cipants 
become too ill, they will not be withdrawn from the study un.l they have 
given their voluntary consent for study withdrawal. 
12.2. Withdrawal Procedures: 
Par.cipants that withdraw from the study for any reason will be noted in 
the REDCap study database and will no longer receive contact from study 
personnel.  The data collected up un.l that point will be used in data 
analysis unless otherwise requested by the par.cipant.   
12.3.  Termina.on Procedures: 
Par.cipants will not be terminated from this study without their consent as 
this is a randomized controlled trial and all par.cipants are to be followed 
regardless of their device use.   
13.
Risks to Par9cipants 
13.1.
Foreseeable Risks:   
This study carries minimal risk and will comply with the University of 
Minnesota IRB repor.ng requirements.  We iden.ﬁed the following 2 
possible risks to subjects:  
Risk to conﬁden.ality:  Par.cipants will be asked to keep their mobile 
phone password protected to guard their conﬁden.ality. Inadvertent 
breaches of conﬁden.ality by inves.gators or their staﬀ are unlikely but 
may occur.   
Iden.fying informa.on will be kept private and all iden.ﬁers will be 
removed prior to any data being given to researchers. The records will be 
iden.ﬁed only with a unique ID number on an encrypted database. Data 
transfer will only occur with de-iden.ﬁed data with encrypted transfer of 
all informa.on containing protected health informa.on between 
par.cipants and study databases.  
 
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PROTOCOL TITLE: Wearable device intervention to improve sun behaviors in 
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Discomfort with survey ques.ons: There is a possibility that some 
par.cipants may feel uncomfortable being asked ques.ons about their 
melanoma diagnosis and health behaviors.  
13.2. Reproduc.on Risks: N/A 
13.3. Risks to Others: N/A 
14.
Poten9al Beneﬁts to Par9cipants 
14.1. Poten.al Beneﬁts: 
There are likely no direct beneﬁts to individual par.cipants.  Individuals in 
both groups may increase their ac.vity level during the study period due to 
promp.ng from the device. Should the interven.on be eﬀec.ve, 
par.cipants may increase their awareness about melanoma and risk factors 
for a second melanoma and may decrease their own risk through improved 
UVR exposure protec.on habits. 
15.
Sta9s9cal Considera9ons 
15.1. Data Analysis Plan:  
All ques.onnaires have been previously developed and implemented and 
will be scored using standard methods.  
15.2. Power Analysis:    
An.cipa.ng 85% of those recruited to the study complete the 12 week 
follow-up survey, a sample size of N=314 par.cipants with outcome data is 
expected. A sample size of 314 will achieve 95% power to detect an eﬀect 
size of 0.40 between interven.on and control groups using a two-sided 
two-sample t-test assuming a signiﬁcance level of 0.05. The eﬀect size is 
similar to that found in an interven.on to promote sun protec.on 
behaviors in high-risk individuals with the same primary outcome 19. 
Importantly, it will also achieve 70% power to compare report of sunburn 
during the interven.on period between the two groups (detect 20% of the 
control par.cipants repor.ng a sunburn – as seen in our preliminary data - 
and 10% of the interven.on par.cipants repor.ng a sunburn) as 
sta.s.cally signiﬁcant at 0.05 signiﬁcance level.  
15.3. Sta.s.cal Analysis:  
 
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PROTOCOL TITLE: Wearable device intervention to improve sun behaviors in 
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Sta.s.cal analysis will focus on evalua.ng the eﬃcacy, unintended 
consequences and implementa.on of the interven.on in this RCT. The main 
analysis of the primary outcome (self-reported overall sun protec.on score) 
will be a two-sample two-sided two-sample t-test comparing scores at the 
end of the interven.on period (12 weeks) between interven.on and 
control groups. Randomiza.on should result in two groups that are similar 
for pa.ent characteris.cs and other extraneous factors that may inﬂuence 
sun exposure and protec.on behaviors, however, we will compare the 
randomized groups by Wave, gender, age, stage of disease, device use (low/
high), and baseline measures of sun protec.on and exposure behaviors 
using two-sample t-tests and Chi-squared tests to iden.fy poten.al 
confounding factors which may not be balanced between the two groups. 
We will supplement the primary analysis with a mul.variate linear 
regression model to account for any iden.ﬁed diﬀerences at baseline. A 
secondary analysis will explore changes in the sun protec.on score over the 
interven.on period (baseline, weeks 4, 8 and 12) using a mixed eﬀects 
regression model. This analysis will not be completed un.l both Waves 
have been conducted. 
Secondary analyses will focus on each self-reported sun protec.on 
behavior separately, sunburns, inten.onal tanning, skin cancer knowledge, 
and physical ac.vity and health behaviors by comparing the interven.on 
and control par.cipants over the study interven.on period and 1 year post-
comple.on. Analyses will be conducted using Chi-squared and t-tests as 
appropriate for univariate analyses at each .me point and logis.c and 
linear regression models for mul.variate analyses. Daily UVR data (minutes 
of UVR exposure per day) will be summarized using the area under the 
curve (AUC) over the 12 week interven.on period. Proper transforma.on 
(e.g. log-transforma.on) will be applied if the AUC data are skewed. The 
two groups’ AUC will be compared using similar methods as proposed 
above. The associa.on between sun exposure and its poten.al modera.ng 
eﬀect on sun protec.on behaviors during the interven.on will be 
inves.gated using linear mixed eﬀects models including main and 
interac.on eﬀects, adjus.ng for poten.al confounders. To address any 
poten.al interven.on eﬀects in the control group, we will compare the 
baseline and post-interven.on sun protec.on behaviors scores using paired 
t-tests, stra.fying by randomiza.on group. The propor.ons of survivors in 
the interven.on and control groups with poten.ally clinically signiﬁcant 
depression and anxiety will be compared using Chi-squared tests and 
supplemented with mul.variate logis.c regression models. Finally, 
descrip.ve sta.s.cs will be used to summarize the implementa.on metrics 
 
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both across and within randomiza.on group both between Waves 1 and 2 
and aier comple.on of the study.  
We plan to perform all primary sta.s.cal analyses following inten.on-to-
treat (ITT) procedures. That is, all subjects allocated to a treatment or 
interven.on will be followed up, evaluated, and analyzed as members of 
that group or treatment arm regardless of their compliance with the 
assigned treatment. While it is not expected that par.cipants will be 
incorrectly assigned, some may not use the device and certain features. For 
that reason, we will also summarize device use and consider sensi.vity 
analyses exploring the interven.on eﬀect using per-protocol methods 
(incorpora.ng device use) as opposed to ITT. A priori, we an.cipate that 
the amount of use of the interven.on will predict sun protec.on and 
exposure behaviors, though we will likely be underpowered for this 
analysis.  
Every eﬀort will be made to encourage par.cipants’ compliance and data 
completeness. Nevertheless, we expect some amount of missing data. We 
plan to perform a comprehensive missing data analysis employing sta.s.cal 
methods that are valid under diﬀerent missingness assump.ons to 
determine if conclusions are sensi.ve to missing data. The primary missing 
data method will be mul.ple imputa.on using the Markov Chain Monte 
Carlo (MI-MCMC) method 36,37 assuming that data are missing at random—
that is, the probability that an observa.on is missing can depend on the 
observed data but not on the missing data. We will include appropriate 
baseline variables into the MCMC procedure to make the condi.onal 
independent missing assump.on less stringent. If the treatment group is 
associated with missingness, we will conduct mul.ple imputa.on for each 
treatment group separately 38. The MI-MCMC method allows arbitrary 
missing paTerns including intermiTent missing and dropout. We will also 
perform a simple imputa.on analysis as a sensi.vity analysis; speciﬁcally, 
the linear interpola.on method will be used for intermiTent missing (e.g., 
when people forget to charge or wear the device), while the last week 
average value carried forward method will be used for dropouts, assuming 
that the average of the last 7 days’ data will be a good es.mate of the 
missing data.  
15.4. Data Integrity:  
Data will be entered and stored in REDCap.  Data will be reviewed for 
completeness and cleanliness on an ongoing basis by the study coordinator 
and sta.s.cian.  
16.
Conﬁden9ality 
 
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16.1. Data Security:   
All study inves.gators and staﬀ will be fully trained on data safety and 
par.cipant conﬁden.ality using appropriate HealthPartners, CITI and 
University of Minnesota courses.  An electronic copy of the signed consent 
and HIPAA forms will be stored on an AHC-IS supported server and the 
paper copy (if collected) will be stored in a locked ﬁle cabinet in a locked 
oﬃce.  The consent form and other research informa.on will NOT be 
placed in the par.cipants’ medical record. 
Electronic data will be entered by the study coordinator and will be stored 
on the secure REDCap database. Study data will be de-iden.ﬁed before 
data analysis. Only the researchers directly involved with the study will 
have access to the data. Iden.fying data will be stored un.l comple.on of 
the study and manuscript submission.   
17.
Provisions to Monitor the Data to Ensure the Safety of Par9cipants 
17.1. Data Integrity Monitoring: 
The PI will review all signed consent and HIPAA authoriza.on forms for 
completeness at the .me of par.cipant entry into the study.   
Apart from the UVR and physical ac.vity data that are automa.cally 
collected by the wearable devices, data collec.on will occur primarily using 
REDCap, which will be set up to ensure data are clean and ready for 
analysis.  Reports within REDCap will be used to iden.fy missing data.   
17.2. Data Safety Monitoring: 
This study carries minimal risk and therefore the PI will assume 
responsibility for monitoring and repor.ng safety concerns/events to the 
University of Minnesota IRB.  Events requiring prompt repor.ng include any 
adverse event that requires a change to the protocol or consent form, any 
unauthorized disclosure of conﬁden.al informa.on, any unresolved subject 
complaint or any protocol devia.on that resul.ng in harm or the 
unan.cipated death of an enrolled subject.   
Any event requiring prompt repor.ng to the IRB will also be reported to the 
Masonic Cancer Center’s SAE Coordinator (email - mcc-saes@umn.edu). 
18.
Provisions to Protect the Privacy Interests of Par9cipants 
18.1. Protec.ng Privacy: 
Iden.fying informa.on will be kept private and secure as described above.  
Iden.ﬁers will be removed prior to data analysis. The records will be 
iden.ﬁed only with a unique ID number on an encrypted database. Data 
 
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transfer will only occur with de-iden.ﬁed data with encrypted transfer of 
all informa.on containing protected health informa.on between 
par.cipants and study databases. 
Par.cipants will be reminded they do not need to answer any survey 
ques.ons they do not want to and that they can withdraw from the study 
at any point.   
18.2. Access to Par.cipants:  
All par.cipants will be asked to provide a signed HIPAA authoriza.on form 
indica.ng their agreement for the research study team to access their 
medical records pertaining to their melanoma diagnosis and treatment.  
19.
Compensa9on for Research-Related Injury 
19.1. Compensa.on for Research-Related Injury: N/A 
19.2. Contract Language: N/A 
20.
Consent Process 
20.1. Consent Process:   
Consent and HIPAA forms to par.cipate in the RCT will be part of the ini.al 
recruitment mailing package from the University of Minnesota. The current 
plan is to include a self-addressed envelope for par.cipants to return 
signed consent forms back to the study team, however, we have also 
planned to convert to email invita.on and electronic consent given the 
COVID-19 health crisis and the poten.al for needing to coordinate the 
study en.rely online. If a par.cipants requires more informa.on, they can 
state that before deciding whether or not they would like to par.cipate in 
the study, and the study will be explained in more detail. 
Consent and HIPAA forms will be stored in a secure ﬁle cabinet in a locked 
oﬃce in addi.on to being scanned and stored on password-protected 
secure servers. Online consents and HIPAA forms will obtain signatures 
captured electronically via the e-consent func.onality in REDCap. At the 
boTom of the e-consent par.cipants are asked whether they wish to 
receive signed copies or opt out of receiving them. Those wishing to receive 
them will provide their mailing address to receive paper copies through the 
USPS mail. Addi.onally, par.cipants will also have the op.on to download 
signed copies of these documents to their own computer or electronic 
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Electronic signatures will be stored within REDCap as well as a copy on the 
Academic Health Center (AHC) secure servers. Access to these records will 
be limited to the study team as needed or required. 
20.2. Waiver or Altera.on of Consent Process (when consent will not be 
obtained): We will request a waiver of consent through HealthPartners to 
access medical records to iden.fy members (and pa.ents if needed) 
eligible for the study who will be contacted via mail and phone by 
HealthPartners.  
20.3. Waiver of WriTen/Signed Documenta.on of Consent (when wriTen/signed 
consent will not be obtained): HealthPartners will be reques.ng a waiver of 
documenta.on of consent for wriTen consent for permission to provide 
contact informa.on to the University of Minnesota. Recruited individuals 
will provide verbal consent via their recruitment phone call to proceed to 
study enrollment (wriTen consent through University of Minnesota).   
20.4. Non-English Speaking Par.cipants: N/A   
20.5. Par.cipants Who Are Not Yet Adults (infants, children, teenagers under 18 
years of age): N/A 
20.6. Cogni.vely Impaired Adults, or adults with ﬂuctua.ng or diminished 
capacity to consent: N/A 
20.7. Adults Unable to Consent: N/A 
21.
Se[ng 
21.1. Research Sites:  
The research will be conducted by the University of Minnesota and 
HealthPartners. This study will have a single recruitment site as we will only 
recruit individuals through HealthPartners members (and poten.ally 
pa.ents). Par.cipants can ﬁll out the study survey from any loca.on with 
online access.  Both sites will conduct their own scien.ﬁc and ethics review 
of the protocol and provide documenta.on of approval. 
21.2. Interna.onal Research:  N/A 
22.
Mul9-Site Research  
N/A 
23.
Resources Available 
 
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23.1. Resources Available: 
Funding: This study will be conducted with grants to R.I. Vogel from the 
American Cancer Society and Melanoma Research Alliance. 
Research team: All inves.gators are commiTed to this project and will 
provide appropriate eﬀort as needed.  Dr. Vogel will have a study 
coordinator who will be supported 50% .me to conduct the study.   
Par.cipant Availability: HealthPartners is the largest consumer-governed 
nonproﬁt health care organiza.on in the country, providing care, coverage, 
research, and educa.on to improve health and well-being in partnership 
with its members, pa.ents and community. Founded in 1957, the 
HealthPartners family of care serves more than 1.5 million medical and 
dental health plan members and more than 1 million pa.ents. The 
organiza.on includes a mul.specialty group prac.ce of more than 1,700 
physicians; 7 hospitals; 47 primary care clinics; 22 urgent care loca.ons; 22 
dental clinics; and numerous specialty prac.ces in Minnesota and western 
Wisconsin. Given very low levels of uninsured in Minnesota (single-digit 
percentages over the past decade), high popula.on penetra.on of 
managed care in the state, and a high health insurance market-share, the 
HealthPartners member and pa.ent popula.ons are generally 
representa.ve of the larger popula.on.  
Using data from HealthPartners 2010-2016, we expect over 2000 members 
will meet our eligibility criteria. We have previously found melanoma 
survivors to be highly mo.vated to par.cipate in research, with 
par.cipa.on rates of 70-85% for interviews and focus groups. While this is 
a more intensive study, we an.cipate no issues recrui.ng 248 individuals. 
The research outlined in this protocol was presented to the Cutaneous 
Oncology Transla.onal Working Group in December 2017 and was met with 
enthusiasm from the dermatologists, surgeons, and oncologists trea.ng 
pa.ents with melanoma at the University of Minnesota.  They verbally 
agreed to support this study and should recruitment by HealthPartners 
become a concern, University of Minnesota/Fairview pa.ents may be 
considered.   
UNIVERSITY OF MINNESOTA  
The University of Minnesota is one of the state’s greatest assets. It is one of 
the most comprehensive universi.es in the United States and ranks among 
the most pres.gious. The University, with more than 370 ﬁelds of study, 
oﬀers more choices and unique opportuni.es for its 60,000 students. It is 
 
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both the state land grant university and Minnesota’s only research 
university, where new knowledge, new products, and new services improve 
the quality of life for all Minnesotans. Another major resource is the 
University of Minnesota’s research ac.vi.es. The University is one of the 
leading recipients of federal research awards. The University received more 
than $520 million in grant and contract awards from federal, state, and 
private sources in ﬁscal year 2010 and ranks in the top 10 of all public and 
private research universi.es. The University conducts 98 percent of all 
sponsored academic research in Minnesota.  
Some of the many major resources at the University of Minnesota include 
an extensive library system. The University of Minnesota Libraries is one of 
the University's and the state's greatest intellectual and capital assets. 
Housed in 14 facili.es on the three Twin Ci.es campuses, the University 
Libraries' collec.ons contain 6.2 million print volumes, nearly 37,000 serial 
subscrip.ons, 6.3 million microforms, 2.65 million government documents, 
and 423,000 maps, making it the 16th largest research library in North 
America. Finally, the University of Minnesota has taken an aggressive, 
proac.ve stance in crea.ng an atmosphere that is compliant with the 
Health Insurance Portability and Accountability Act (HIPAA). All personnel 
with any access whatsoever to human subject data, including custodians, 
are required to take a 3-part HIPAA training session. In addi.on, all 
individuals who work directly with human subjects data are required to 
take a course in protec.on of human subjects and all key personnel are 
required to take a 2-part course on the responsible conduct of research. 
For this proposal, two research team members have academic homes in the 
Medical School, speciﬁcally, the Division of Gynecologic Oncology in the 
Department of Obstetrics, Gynecology and Women’s Health (Vogel) and 
Department of Dermatology (Ahmed-Saucedo), two members are located 
in the School of Public Health, including the Division of Epidemiology and 
Community Health (Lazovich) and the Division of Biosta.s.cs (Luo), and 
one member is located in the School of Journalism and Mass 
Communica.on (Nagler). The resources and environment for each School 
are described below. All University of Minnesota research team members 
are also members of the Masonic Cancer Center.  
MEDICAL SCHOOL  
DEPARTMENT OF OBSTETRICS, GYNECOLOGY AND WOMEN’S HEALTH 
The department is a na.onally recognized en.ty that maintains several 
highly produc.ve established programs while regularly adding new 
ini.a.ves. Today the department hosts three very ac.ve academic 
 
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divisions: Gynecology Oncology, Maternal Fetal Medicine and General 
Gynecology. On an annual basis, The Department of Obstetrics and 
Gynecology successfully compete for signiﬁcant Federal and private 
funding. These endeavors regularly involve partnerships with other units 
within the Academic Health Center such as the Na.onal Center for 
Excellence in Women’s Health. 
The Division of Gynecologic Oncology is heavily engaged in funded 
laboratory and clinical research. All faculty members are members of the 
Comprehensive Cancer Center and receive addi.onal support from an NCI 
Cancer Center Support Grant. Support for the Division’s extensive research 
ac.vi.es is also provided by peer-reviewed na.onal non-proﬁt 
organiza.ons such as the Minnesota Medical Founda.on, the Gynecologic 
Cancer Founda.on (GCF), and a variety of other philanthropies and 
individual dona.ons. Currently, the faculty has been awarded grants with 
total annual directed funds of more than $1,200,000 and 6 industry-
sponsored studies exceeding $1,500,000.  
Oﬃce: Dr. Vogel has a private oﬃce in the Division of Gynecologic Oncology 
on the 12th ﬂoor of Moos Tower (Room 12-262) at the University of 
Minnesota. The 12th ﬂoor also provides space for research staﬀ to work. 
Each desk includes a desktop computer and/or a network connec.on for a 
laptop. Two conference rooms are available on the same ﬂoor for group 
mee.ngs.  
Computer Services: Dr. Vogel has a personal computer linked via Ethernet 
to a secure University network hosted by the Academic Health Center 
Informa.on Services (AHS IS). The group supports databases, applica.ons, 
web sites, ﬁle storage, and development of new tools. 
Data Management and Analysis So`ware: Dr. Vogel has access to and 
regularly uses the Microsoi suite (Word, Excel, PowerPoint, and Access), 
SAS, PASS 14, R, and Prism. The University of Minnesota supports the use of 
REDCap, a web-based data collec.on system, for its researchers through 
the Clinical Transla.onal Research Ins.tute (hTp://www.ctsi.umn.edu/
research/tools-soiware/REDCap/).  
Support Services: The Department of OB/GYN works with the Department 
of Pediatrics to employ full-.me staﬀ of professional administrators to 
ensure that sponsored research projects, including research budgets, are 
appropriately managed and receive oversight to ensure responsible use of 
funds from sponsored research. These staﬀ include an execu.ve 
administrator, an oﬃce manager, a team of accountants, pre- and post-
award grants managers and administra.ve assistants. These local services 
 
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are supported by centralized university services including the Sponsored 
Projects Administra.on (hTp://www.ospa.umn.edu/) and the Ins.tu.onal 
Review Board (hTp://www.research.umn.edu/irb), which are housed 
within the Oﬃce of the Vice-President for Research (OVPR) (hTp://
www.research.umn.edu/). The University has numerous policies 
established for the protec.on of research subjects and the responsible 
management and oversight of the research conducted by University 
employees. These policies are available through the OVPR website.  
DEPARTMENT OF DERMATOLOGY  
On February 7, 1913, the Division of Dermatology and Genito-Urinary 
Diseases was created in the Department of Surgery at the University of 
Minnesota, and in 1914, Dermatology became a division in the Department 
of Medicine. In 1971, with the return of Dr. Robert W. Goltz from the 
University of Colorado to the University of Minnesota, Dermatology 
became a Department. Over 30 ac.ve faculty provide care and research in 
ﬁve divisions at the University site. These divisions include General 
Dermatology, Dermatologic Surgery, Pediatric Dermatology, Clinical 
Research and Dermatopathology. The teaching program is based at four 
teaching sites – University of Minnesota Medical Center, Fairview, Veterans 
Aﬀairs Medical Center (VA), Hennepin County Medical Center, Park-
Nicollet/Health Partners and the Children’s Hospital. Twenty-three 
residents rotate through these clinical sites in either categorical, internal 
medicine/dermatology or 2+2 residency programs. In addi.on to the 
dermatology residency programs, two fellowships are provided - in 
Pediatric Dermatology and Procedural Dermatology. Research is conducted 
primarily at the University and the VA sites and is collabora.ve and inter-
disciplinary with faculty also associated with the Center for Immunology, 
Department of Pediatrics, Melanoma and Skin Cancer Program and the 
Clinical and Transla.onal Scien.ﬁc Ins.tute (CTSI). Faculty are ac.ve in both 
local and na.onal organiza.ons including the Associa.on of Professors of 
Dermatology, the Society for Inves.ga.ve Dermatology and the American 
Academy of Dermatology. Faculty are also ac.ve members of na.onal 
commiTees or boards including the NIH Arthri.s, Connec.ve Tissue and 
Skin Study Sec.on and the Board of Directors of the Na.onal Alopecia 
Areata Founda.on and Cicatricial Alopecia Research Founda.on.  
Dr. Ahmed has oﬃce space in the Department of Dermatology and 
par.cipates regularly in the Department’s Clinical Research Division’s grant 
related ac.vi.es. The Dermatology Clinic is located in the Clinics and 
Surgery Center (CSC). The University of Minnesota Clinics and Surgery 
Center is a new, 342,000-square-foot care facility that opened in February 
 
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2016 on the East Bank of the University of Minnesota Medical Center 
campus. 
SCHOOL OF PUBLIC HEALTH (SPH)  
The University of Minnesota School of Public Health (SPH) was founded in 
1944 and provides graduate-level training in Public Health for scholars and 
health professionals from around the world. SPH is consistently recognized 
as one of the top public health programs in the country. SPH has 135 core 
faculty members across four academic divisions (Epidemiology and 
Community Health, Biosta.s.cs, Health Policy and Management, and 
Environmental Health) who teach and conduct research in 
popula.ons on disease preven.on and health promo.on.  
SPH - Division of Epidemiology and Community Health  
The Division of Epidemiology and Community Health (EpiCH) is the largest 
of four divisions in the School of Public Health. For over 70 years, EpiCH has 
led regional, na.onal, and interna.onal studies of the distribu.on, causes, 
and preven.on of major diseases. The signature EpiCH project is the 
ambi.ous and groundbreaking Seven Countries study (hTp://sph.umn.edu/
about/history/halfcentury) led by public health pioneer Ancel Keys, which 
accelerated the preven.on and treatment of cardiovascular disease and 
popularized the Mediterranean Diet.  
EpiCH has 43 primary faculty members with diverse backgrounds and 
program emphasis in Clinical/Biological Sciences and Social/Behavioral 
Sciences. Current EpiCH faculty members are among the leading 
researchers in the world. In addi.on to all of the substan.ve research 
areas, EpiCH has a core set of faculty who work extensively in 
epidemiologic methods (hTp://www.sphresearch.umn.edu/epi/
epidemiologic-methods) with speciﬁc exper.se in mixed model regression, 
longitudinal data analysis, and latent variable modeling.  
EpiCH faculty collec.vely have been awarded between $30 and 50 million 
annually in sponsored funds over the past decade to support ongoing 
research, the majority of which are compe..ve grant awards from NIH. As 
a func.on of the Division’s focus on extramural sponsored research, EpiCH 
Division Head Dr. Dianne Neumark-Sztainer has created a formal mentoring 
program to foster rela.onships for the express purpose of promo.ng grant 
wri.ng and research implementa.on skills among junior faculty members 
by drawing upon the considerable exper.se and success of experienced 
senior EpiCH faculty. The Division fosters regular communica.on among 
faculty members to provide peer support for all phases of the research 
process.  
 
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Dr. Lazovich has dedicated oﬃce space and support from Division 
administra.ve staﬀ. 
SPH - Division of Biosta9s9cs  
The Division of the Biosta.s.cs at the University of Minnesota ranks 
consistently in the top eight of biosta.s.cs programs in the United States. 
They have played a leadership role in many na.onal and interna.onal 
clinical trials, including the ﬁrst vaccine trial for Ebola and the largest HIV/
AIDS treatment trial in history.  
The Division of Biosta.s.cs focuses on the development of sta.s.cal 
methods for biomedical research. They have faculty who specialize in 
numerous areas and collaborate with University research partners on 
projects involving HIV/AIDS, heart and lung disease, cancer, neuroimaging, 
and many other clinical disciplines. Performing methodological research in 
areas including Bayesian analysis, spa.al sta.s.cs, sta.s.cal gene.cs, and 
causal inference, division faculty, students, and staﬀ are involved in more 
than 100 research grants and contracts totaling more than $150 million. 
Dr. Luo has dedicated oﬃce space and support from Division administra.ve 
staﬀ. 
SCHOOL OF JOURNALISM AND MASS COMMUNICATION  
First established as an academic department in 1922 and housed in Murphy 
Hall since 1939, the University of Minnesota’s School of Journalism and 
Mass Communica.on is one of the oldest programs in the United States. 
Murphy Hall underwent a $10.5 million renova.on in 2000, thus crea.ng a 
state-of-the art facility for research and teaching in the areas of journalism, 
mass communica.on, and new media studies. Roughly 1,000 
undergraduates pursue a major or minor in the program every year, and 
approximately 100 graduate students pursue MA and PhD degrees in 
Strategic Communica.on or Mass Communica.on.  
The School of Journalism and Mass Communica.on beneﬁts from state-of-
the-art research, media produc.on, and classroom facili.es. Research 
facili.es include the Communica.on Research Division Laboratory, which 
provides dedicated space for focus group and message tes.ng research. 
Occupying approximately 400 square feet on the third ﬂoor of Murphy Hall, 
the space includes a recep.on area, focus group suite (including an 
observa.on control room), three par.cipant tes.ng rooms, and kitchen 
facili.es. Addi.onal features of the lab include an eye-tracking machine for 
use in message tes.ng research, as well as a mobile game cart with game-
playing devices for use in game simula.on research. As a member of the 
 
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Communica.on Research Division, Dr. Nagler has full access to the lab and 
its resources.  
The School of Journalism and Mass Communica.on is also a stakeholder in 
the University of Minnesota’s Usability Services Lab, housed in the Walter 
Library Digital Technology Center. This lab provides technology and space 
for researchers to conduct usability tes.ng (for example, eye-tracking 
studies of website naviga.on) and media eﬀects research. In addi.on, as a 
faculty member in the College of Liberal Arts, Dr. Nagler has access to the 
University of Minnesota’s Social and Behavioral Sciences Laboratory (SBSL). 
The SBSL allows researchers to run mul.ple research subjects 
simultaneously, each at their own computer. These facili.es are supported 
by a lab manager, lab technician, and research-compu.ng consultants from 
the College of Liberal Arts’ Oﬃce of Informa.on Technology. Academic 
oversight is provided by College of Liberal Arts Associate Dean Dr. 
Alexander Rothman. The SBSL oﬀers the following resources: 44 networked 
worksta.ons with Windows XP, 19-inch LCD screens, high-quality 
headphones, 22 serial response boxes, 22 microphones, and custom-
conﬁgurable privacy carrels for all worksta.ons. Data security in the SBSL is 
provided by a custom ﬁrewall for the lab network and op.onal encryp.on 
of internal network traﬃc. Pre-installed experiment soiware packages E-
prime and Presenta.on are available to all researchers; custom 
conﬁgura.ons can be arranged.  
Beyond its research facili.es, Murphy Hall has myriad media produc.on 
resources. Located on the ground ﬂoor of Murphy Hall, the Digital Media 
Studios is a newsroom-like media laboratory that has capability for video 
edi.ng; digital and analog audio; and imaging, graphics, and 
communica.on design. It also includes a television studio. The Digital 
Informa.on Resource Center and Sevareid Library, located next to the 
Digital Media Studios, is equipped with tradi.onal and digital informa.on 
resources for use in research and teaching, and includes eight networked 
worksta.ons and two teaming rooms with digital edi.ng capability.  
Dr. Nagler has a permanent faculty oﬃce in Murphy Hall. Support staﬀ 
include two full-.me computer system specialists, who provide network 
and programming support to faculty.  
MASONIC CANCER CENTER  
The Masonic Cancer Center serves to advance knowledge by crea.ng a 
collabora.ve research environment focused on the causes, preven.on, 
detec.on, and treatment of cancer; applying that knowledge to improve 
quality of life for pa.ents and survivors; and sharing its discoveries with 
 
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other scien.sts, students, professionals, and the community. It was 
founded in 1991, and is part of the University's Academic Health Center, 
which also includes the Medical School, Dental School, College of 
Pharmacy, and Schools of Public Health and Veterinary Medicine. The 
Masonic Cancer Center includes more than 500 faculty and staﬀ members. 
It is home to some of the world's top cancer researchers in bone marrow 
transplanta.on, breast cancer, bone cancer, cancer gene.cs, tobacco 
research, immunology, new therapies development, pediatric oncology, 
chemopreven.on, and epidemiology. The Na.onal Cancer Ins.tute (NCI) 
designated the Masonic Cancer Center, University of Minnesota a 
comprehensive cancer center in 1998, and in 2003, 2009, and 2013, NCI 
renewed this designa.on. The Masonic Cancer Center is one of only 41 
ins.tu.ons in the United States to hold this designa.on. It is awarded only 
to ins.tu.ons that make ongoing, signiﬁcant advances in cancer research, 
treatment, and educa.on. The Masonic Cancer Center has held an 
American Cancer Society Ins.tu.onal grant for many years.  
Biosta(s(cs Core: Both Drs. Vogel and Luo are members of the Biosta.s.cs 
Core, a shared resource of the Masonic Cancer Center with the primary 
objec.ve to provide centralized biosta.s.cs services, collabora.ve 
research, and data management support for the research projects. The 
shared resource serves as the focal point from which inves.gators and their 
team members and/or associates at the Masonic Cancer Center can draw 
biosta.s.cs exper.se for the design, data management, and analysis of 
their research projects.  
The aims of the Biosta.s.cs and Bioinforma.cs shared resource are to:  
Provide biosta.s.cs exper.se in study design, including endpoint 
deﬁni.on, sample size es.ma.on and power calcula.on, randomiza.on 
procedures, data collec.on from design, plans for report genera.on, 
interim reviews, and ﬁnal analysis.  
Provide biosta.s.cs analyses and support for all cancer research projects 
using contemporary sta.s.cal and compu.ng methodologies; and  
Provide biomedical informa.cs and data management support for the 
development and management of all research projects, as well as projects/
Core speciﬁc databases by all inves.gators and their team and/or 
associates at the Masonic Cancer Center.  
Soiware resources for biosta.s.cs at the Masonic Cancer Center include 
but are not limited to Microsoi Windows XP, Microsoi Access, Excel, 
PowerPoint, Word 2003, Macromedia DreamWeaver 8.0; Adobe Acrobat ; 
MacAfee Virus protec.on ; PASS, Power, CTDS, and NQuery Advisor; SAS 
 
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9.1; SPLUS 8.0; Computers are linked via Ethernet to the University system. 
All databases are backed-up nightly. The Biosta.s.cs Core is supported by 
the Academic Health Center Informa.on Services along with the Medical 
School. When appropriate we collaborate with other University of 
Minnesota resources including the Minnesota Supercompu.ng Ins.tute 
(MSI) and the Oﬃce of Informa.on Technology (OIT). We u.lize a mix of 
opera.ng environments depending on the applica.on requirement, 
including Linux, Solaris, and Windows.  
HEALTHPARTNERS AND HEALTHPARTNERS INSTITUTE 
HealthPartners is the largest consumer-governed nonproﬁt health care 
organiza.on in the country, providing care, coverage, research, and 
educa.on to improve health and well-being in partnership with its 
members, pa.ents and community. Included under HealthPartners’ 
umbrella are Regions Hospital (a ter.ary-care hospital in St. Paul, MN), Park 
Nicollet HealthPartners Care Group, HealthPartners Center for Memory & 
Aging, Park Nicollet Methodist Hospital (a 426-bed facility with more than 
960 physicians in St. Louis Park, MN) and HealthPartners Ins.tute. 
HealthPartners has formal rela.onships with hospitals and clinics 
throughout Minnesota and western Wisconsin, including Wesxields 
Hospital (New Richmond, WI), Lakeview Hospital (S.llwater, MN), Hudson 
Hospitals and Clinics (Hudson, WI), Amery Hospital and Clinic (Amery, WI), 
St Francis Regional Medical Center (Shakopee, MN) and Physicians Neck 
and Back Clinic (loca.ons in Roseville, Woodbury, Coon Rapids, Edina, 
Burnsville, and Maple Grove, MN). 
Founded in 1957, the HealthPartners family of care serves more than 1.5 
million medical and dental health plan members and more than 1.2 million 
pa.ents. In 2013, HealthPartners and Park Nicollet Health Services 
combined under the name HealthPartners and a single consumer-governed 
board of directors. The new organiza.on includes a mul.specialty group 
prac.ce of more than 1,700 physicians; 7 hospitals; 47 primary care clinics; 
22 urgent care loca.ons; 22 dental clinics; and numerous specialty 
prac.ces in Minnesota and western Wisconsin. HealthPartners is the top-
ranked commercial health plan in Minnesota and is ranked among the top 
30 plans in the na.on, according to the Na.onal CommiTee for Quality 
Assurance’s Health Insurance Plan Rankings 2013-2014. For more 
informa.on, visit www.healthpartners.com.  
HealthPartners Ins9tute Services and Infrastructure: 
 
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HealthPartners Ins9tute (the Ins.tute) is a 501c(3) nonproﬁt organiza.on 
dedicated to conduc.ng high quality, public-domain health research, oien 
in collabora.on with other academic and research organiza.ons 
throughout the world. On January 1, 2016, HealthPartners Ins.tute for 
Educa.on and Research and Park Nicollet Ins.tute combined to form one 
of the largest medical research and educa.on centers in the region. The 
combined HealthPartners Ins.tute employs 33 career research inves.gators 
and more than 400 clinician researchers and encompasses vast and varied 
areas of research including neurosciences, cri.cal care, dental and oral 
health, maternal and child health, chronic disease, cancer, clinical research, 
health economics, mental health, Struthers Parkinson’s Center and Park 
Nicollet Interna.onal Diabetes Center. In addi.on, the Ins.tute par.cipates 
in nine na.onal research networks including the Health Care Systems 
Research Network, the Vaccine Safety Datalink, the Cancer Research 
Network and the Mental Health Research Network. For more informa.on, 
visit www.healthpartnersins.tute.org. 
A large in-house professional support team helps inves.gators with 
proposal development, research study coordina.on, accessing and 
processing data and a range of other needs. The professional staﬀ includes 
full-.me study coordinators, phone coaches, research technicians and 
administra.ve staﬀ. An onsite Survey Research Center conducts surveys 
and chart review. A research librarian conducts literature searches. Oﬃce 
resources include more than 300 worksta.on computers networked with 
the HealthPartners- and Ins.tute-owned computer systems that reside with 
HealthPartners-owned systems at a secure oﬀsite compu.ng facility.  
The Ins.tute administers both external and internal grants for 
inves9gators. A number of diﬀerent government agencies, founda.ons and 
industries funds external grants, while the Ins.tute itself awards internal 
grants. A small number of internal grants of up to $60,000 and up to two 
year project periods are awarded annually to HealthPartners or Park 
Nicollet employees for purposes of discovery, or research program 
development. Proposals are reviewed internally for science and merit and 
receive special considera.on if they address key organiza.onal priori.es.  
The Ins.tute has an accoun9ng and ﬁnance unit dis.nct from 
HealthPartners that is an independent ﬁscal agent for all grants and 
contracts. In 2016, the Ins.tute had a budget of $37.5 million from grants 
and contracts from various government agencies (NIH, CDC, AHRQ), 
founda.ons and corpora.ons.  
The Ins.tute has a team of research programmers and applica.on 
developers in our Research Informa9cs and Informa9on Systems (RIIS) 
 
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department. Capabili.es of this team include tracking database 
development, web development, SAS and SQL query and integra.on of 
elements in the electronic medical record. The team consists of four 
divisions: Applica.on Development, Data Systems & Architecture, Virtual 
Data Warehouse (VDW) Architecture and Opera.ons, and Research 
Informa.cs.  
Applica9on Development: This team focuses on Web-based applica.ons, 
backend Web services, client server applica.ons and the development and 
maintenance of the Ins.tute and study-related Web sites. Its members 
have extensive exper.se in backend database and agile soiware 
development. 
Data Systems and Architecture: This area develops the Epic electronic 
medical record system, internal data structures and the Ins.tute Data Mart. 
The Ins.tute Data Mart is a long-term project to increase produc.vity by 
allowing easier, faster access to data per.nent to Ins.tute research. The 
Data Systems and Architecture Team is central to our data-coordina.on 
eﬀorts with single-site and mul.site studies. 
VDW Architecture and Opera9ons: The VDW is a long-term eﬀort to 
facilitate collabora.on with other research organiza.ons by allowing the 
pooling and manipula.on of common data elements. This team consists of 
2.25 dedicated programmer analysts, with assistance from the Research 
Informa.cs Team. 
Research Informa9cs: This team works with researchers to iden.fy and 
analyze informa.on to answer research ques.ons. Members help with 
proposal development and use tools and technologies to extract and 
combine data from diﬀerent data sources to create a comprehensive record 
for research. Managers of this team ensure adequate staﬃng so that a 
team is convened at the start of a project.  
The Ins.tute has implemented a comprehensive internal Regulatory 
Process to ensure scien.ﬁc merit and research subject safety. The Ins.tute 
is one component of a larger organiza.on deﬁned as an aﬃliated covered 
en.ty (ACE) under HIPAA regula.ons. The Ins.tute’s link with the Park 
Nicollet HealthPartners Care Group and Regions Hospital enables 
researchers to explore the feasibility of protocol design and iden.fy 
par.cipants for study proposals from member and pa.ent databases. In 
compliance with HIPAA regula.ons, the Ins.tute established a ﬁrewall 
between the overall data warehouse, which includes medical records and 
administra.ve data, and all research staﬀ. As a result, only Ins.tute 
programmers have direct access to protected health informa.on as deﬁned 
 
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by HIPAA. They also have permission to release certain informa.on to 
researchers in prepara.on for research and, once projects have received 
the required approvals (scien.ﬁc and Ins.tu.onal Review Board [IRB]), 
direct access to use of medical records data and other administra.ve data.  
The Ins.tute’s IRB meets twice monthly to review pending proposals. The 
IRB is accredited by the Associa.on for the Accredita.on of Human 
Research Protec.on Programs. The Ins.tute also has a Research Review 
Commibee. This commiTee evaluates the scien.ﬁc importance, feasibility 
and likelihood of the proposed project to 1) contribute new, generalizable 
knowledge to the ﬁeld and 2) improve the health and well-being, 
experience, or aﬀordability of care for our pa.ents, members, or the 
community. All applica.ons to conduct research that involve 
HealthPartners pa.ents or members, including internal grant applica.ons, 
must be reviewed and approved by the research review commiTee.  
The HealthPartners 8170 campus features mul.ple seminar and 
conference rooms that allow for video and audio conferencing. Conference 
rooms have an overhead projec.on system to display computer images, 
installed PC and also a DVD player & VCR combo to view a DVD/video 
through the projec.on system, a Cisco TelePresence System, 70’ high 
deﬁni.on ﬂat screen television, maneuverable mounted camera and 
microphones that have mu.ng capability with indicator lights. These rooms 
also include easel/ﬂipchart, e-net (LAN) computer connec.on for internet/
server access, a digital phone to reach mee.ng aTendees, and an analog 
phone line with dial out capabili.es for conference calls. There are mul.ple 
training rooms for Informa.on Systems, Member Services and Human 
resources provided with equipment including: PC’s, a portable projector, a 
manual pull down screen, easel/ﬂipchart, TV/VCR, E-net (LAN) connec.on 
for internet/server access, and a whiteboard. 
The Ins.tute’s Research Methodology Group (RMG) leads the 
methodological and sta.s.cal ac.vi.es associated with internally and 
externally funded projects. RMG consists of four PhD-level and two master-
level methodologists. The group exper.se includes epidemiologic methods, 
compara.ve eﬀec.veness research, causal inference, biosta.s.cs, and 
demography. RMG facilitates all steps of research, from grant wri.ng, 
planning and execu.on, to analysis and wri.ng for publica.ons.  
The Ins.tute’s Research Methodology Group (RMG) leads the 
methodological and sta.s.cal ac.vi.es associated with internally and 
externally funded projects. RMG consists of four PhD-level and two master-
level methodologists. The group exper.se includes epidemiologic methods, 
compara.ve eﬀec.veness research, causal inference, biosta.s.cs, and 
 
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demography. RMG facilitates all steps of research, from grant wri.ng, 
planning and execu.on, to analysis and wri.ng for publica.ons.  
The Ins.tute features an onsite Center for Evalua.on and Survey Research 
Center (CESR) dedicated to gathering high-quality self-reported data. All 
data is collected in a manner designed to minimize total survey error, 
including error due to nonresponse and measurement. Surveys are 
conducted using mul.ple modes, including mail, telephone, Web and in-
person interviews. Mixed-mode survey methodologies are also commonly 
employed. The CESR is tradi.onally involved in a project during proposal 
development, data collec.on, entry, cleaning, delivery, storage, and 
response tabula.on. Speciﬁcally, the CESR oﬀers these services and 
technologies: 
•
Survey research design 
•
Methodological consulta.on on mode, contact protocol and use 
of incen.ves 
•
Ques.onnaire development (e.g., ques.on order and wording, 
response categories) 
•
Pretes.ng (e.g., sample, ques.onnaire, popula.on, process, cover 
leTers, response rate) 
•
Data collec.on (e.g., mail, telephone, in-person, Web mixed-
mode) 
•
Edi.ng of data 
•
Coding open-ended ques.ons 
•
Scanning 
•
Clinical trial screening 
The CESR is managed by a survey methodologist and health services 
researcher, JeaneTe Ziegenfuss, PhD, who has 12 plus years of experience 
in survey research in the health ﬁeld. She is an ac.ve member of the 
American Associa.on of Public Opinion Research and publishes ar.cles on 
methods to reduce survey error. 
The CESR’s onsite phone center conducts phone interviews as a complete 
survey or as follow up to a mailed survey. The CESR conducts calls from 9 
am to 9 pm weekdays and during the day on Saturdays. For mul.site data 
collec.on, .mes are altered to align with diﬀerent .me zones. The CESR 
has 10 professional telephone interviewers and can conduct interviews in 
English, Spanish, Hmong and Somali. Across modes all data is tracked in 
project-speciﬁc REDCap databases. Call management is orchestrated across 
 
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all projects through a proprietary call management system that wraps 
around REDCap. In addi.on, the equipment and soiware can create and 
capture survey data using scanable forms through Teleform Elite soiware. 
Project sizes vary from small studies with 1-2 subjects per month to large, 
complex, mul.state projects with thousands of par.cipants.  
Research Electronic Data Capture (REDCap): In 2011, the Ins.tute became 
a REDCap consor.um partner. REDCap is a secure Web applica.on for 
building and managing online surveys and databases using: 1) the online 
method from a Web browser using the Online Designer; and/or 2) the 
oﬄine method by construc.ng a data dic.onary template ﬁle in Microsoi 
Excel that can be uploaded into REDCap. Both surveys and databases (or a 
combina.on) can be built using these methods. REDCap provides audit 
trails for tracking data manipula.on and user ac.vity and automated 
export procedures for data downloads to Excel, PDF, and common sta.s.cal 
packages (SPSS, SAS, Stata, R). Also included are a built-in project calendar, 
scheduling module, repor.ng tools and advanced features such as 
branching logic, ﬁle uploading and calculated ﬁelds. 
Data System Capabili9es: The Ins.tute’s networked worksta.on computers 
communicate with the larger HealthPartners corporate network. Our 
systems for storing and backing up data reside both at the HealthPartners 
corporate headquarters and in a secure oﬀsite facility. Data are backed up 
daily, weekly and monthly. Backups are saved for 7 years. The Ins.tute’s 
computer and data needs are supported by the larger organiza.on’s 
Informa.on Systems & Technology Department (IS&T). IS&T maintains all 
HealthPartners computer hardware, soiware and data, including EMR and 
administra.ve data.  
Membership System: The membership system is a corporate database of 
people covered by HealthPartners health insurance from 1990 to today. The 
membership system provides comprehensive member data collected by the 
health plan for administra.ve and ﬁnancial purposes. Membership data is 
collected through enrollment forms, individually, by government programs 
or from an employer group. Sales/Marke.ng gathers employer group 
informa.on with input from Actuarial/Underwri.ng. Membership 
Accoun.ng enters the informa.on into the system for use by all enterprise 
applica.ons. In addi.on, if a pa.ent arrives at a clinic and they are not yet 
enrolled, a mini-registra.on process allows clinic staﬀ to register the 
pa.ent, issue a chart number and proceed with treatment. The major 
business func.ons of the membership applica.on are: 1) maintaining 
employer group informa.on, 2) maintaining member informa.on, 3) 
regulatory processing, and 4) membership repor.ng. For research, this 
 
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database iden.ﬁes people with HP insurance and includes address and 
demographic informa.on and informa.on allowing linkage with the EMR 
and other health data.  
Electronic Medical Record (EPIC/Clarity): All medical care provided by 
HealthPartners-owned facili.es (including clinics and hospitals) is captured 
and maintained in an EMR. Epic supports clinical care and tracks billable 
treatments. For research and other repor.ng purposes, a subset of this 
data is extracted nightly into an Epic database called Clarity. Clarity includes 
demographic, encounter, admission/discharge/transfer, order, medica.on, 
chemotherapy/infusion, laboratory, radiology, pathology, vital sign, 
diagnosis, procedure, immuniza.on, pa.ent-reported outcomes (e.g., 
PHQ-9), physician notes, dates of service, provider, facility, billing, 
scheduling, ﬂowsheet, online access and social history data. Epic data 
elements that do not ﬂow to Clarity can be obtained from a produc.on 
server, Chronicles, which supports the EMR. Lab results go back to 1990 
and encounter data goes as far back as 1997. Computerized physician order 
entry started in 2005. Data origina.ng from Park Nicollet aier July 2011 are 
available in Epic. Prior to that .me, data are available in the legacy Park 
Nicollet electronic medical record. 
Clinical Data Warehouse (CDW): The CDW is a uniﬁed warehouse of clinical 
informa.on sourced from both the HealthPartners and Park Nicollet EMR. 
Standardized ﬁeld names and classiﬁca.on schemes are used to perform 
advanced analy.cs that maximize opera.onal eﬃciency. 
Administra9ve Data Warehouse (ADW): The ADW is a database of claims 
processed by the HealthPartners health plan. These data include 
demographic, enrollment, medical claims, pharmacy claims, dental claims, 
diagnosis, procedure, dates of service, provider, facility, laboratory tests 
performed, referrals to other specialists and ﬁnancial and other billing 
codes. Medical and pharmacy claims data is available back to 1990. 
Research Data Mart (RDM): RDM is a subset of the ADW that allows 
eﬃcient retrieval for standard types of research ques.ons. The database is 
op.mized for ques.ons related to iden.ﬁca.on of pa.ents with par.cular 
condi.ons based on codes (e.g., ICD codes, pharmacy). This dataset is a 
readily accessed archive of research data from the ADW back to the 1990s. 
Virtual Data Warehouse (VDW): The VDW facilitates collabora.on with 
other research organiza.ons by allowing pooling and manipula.on of 
common data elements. The VDW is “virtual” in the sense that the research 
data remain at each Health Care Systems Research Network (HCSRN) site; 
the VDW is a local database designed in collabora.on with other HCSRN 
 
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sites and built to a common set of standardized ﬁle deﬁni.ons. Content 
areas and data elements represent commonly required elements for 
research studies. Primary content areas include enrollment, demographics, 
pharmacy, u.liza.on and cancer (tumor registry). Other content areas are 
census, vital signs, laboratory values and death. For each content area, data 
speciﬁca.ons deﬁne the common format for each element, such as variable 
name, variable label, extended deﬁni.on, code values and value labels. 
Local site programmers have mapped and transformed data elements from 
their local data systems into the standardized set of variable deﬁni.ons, 
names and codes. The VDW facilitates mul.site research in the HCSRN 
because much of the preparatory work for pooling exis.ng data at mul.ple 
sites has been done. 
24.
References 
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American Cancer Society. Cancer Facts and Figures 2016. In. Atlanta: American 
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Gilchrest BA, Eller MS, Geller AC, Yaar M. The pathogenesis of melanoma 
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Narayanan DL, Saladi RN, Fox JL. Ultraviolet radiation and skin cancer. 
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Bradford PT, Freedman DM, Goldstein AM, Tucker MA. Increased risk of second 
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Cruse CW, Wells KE, Schroer KR, Reintgen DS. Etiology and prognosis of local 
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Soong SJ, Harrison RA, McCarthy WH, Urist MM, Balch CM. Factors affecting 
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Ferrucci LM, Vogel RI, Cartmel B, Lazovich D, Mayne ST. Indoor tanning in 
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Lazovich D, Choi K, Vogel RI. Time to get serious about skin cancer prevention. 
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Lazovich D, Vogel RI, Berwick M, Weinstock MA, Anderson KE, Warshaw EM. 
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Lazovich D, Vogel RI, Berwick M, Weinstock MA, Warshaw EM, Anderson KE. 
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Torres SM, Luo L, Lilyquist J, et al. DNA repair variants, indoor tanning, and risk 
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Vogel RI, Ahmed RL, Nelson HH, Berwick M, Weinstock MA, Lazovich D. 
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Lazovich D, Isaksson Vogel R, Weinstock MA, Nelson HH, Ahmed RL, Berwick 
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Vogel RI, Strayer LG, Ahmed RL, Blaes A, Lazovich D. A Qualitative Study of 
Quality of Life Concerns following a Melanoma Diagnosis. Journal of skin 
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Vogel RI, Strayer LG, Engelman L, et al. Comparison of quality of life among 
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Vogel RI, Strayer LG, Engelman L, et al. Sun Exposure and Protection Behaviors 
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Glanz K, Schoenfeld ER, Steffen A. A randomized trial of tailored skin cancer 
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Glanz K, Volpicelli K, Jepson C, Ming ME, Schuchter LM, Armstrong K. Effects 
of tailored risk communications for skin cancer prevention and detection: the 
PennSCAPE randomized trial. Cancer Epidemiol Biomarkers Prev. 
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Heckman CJ, Darlow SD, Ritterband LM, Handorf EA, Manne SL. Efficacy of an 
Intervention to Alter Skin Cancer Risk Behaviors in Young Adults. Am J Prev 
Med. 2016;51(1):1-11. 
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Fogg B. A behavior model for persuasive design. Proceedings of the 4th 
International Conference on Persuasive Technology; 2009; Claremont, California, 
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Holman DM, Berkowitz Z, Guy GP, Jr., Hartman AM, Perna FM. The association 
between demographic and behavioral characteristics and sunburn among U.S. 
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Lloyd-Jones DM, Hong Y, Labarthe D, et al. Defining and setting national goals 
for cardiovascular health promotion and disease reduction: the American Heart 
Association's strategic Impact Goal through 2020 and beyond. Circulation. 
2010;121(4):586-613. 
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Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta 
psychiatrica Scandinavica. 1983;67(6):361-370. 
26. 
Fogg BJ. A Behavior Model for Persuasive Design. In: University S, ed. 
Persuasive. Clairemont, CA2009. 
27. 
Banerjee S, Hoch EG, Kaplan PD, Dumont EL. A comparative study of wearable 
ultraviolet radiometers. Paper presented at: 2017 IEEE Life Sciences Conference 
(LSC)2017. 
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PROTOCOL TITLE: Wearable device intervention to improve sun behaviors in 
melanoma survivors 
VERSION DATE: 07/19/2021 
 
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PROTOCOL TITLE: Wearable device intervention to improve sun behaviors in 
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VERSION DATE: 07/19/2021 
Appendix: Summary of Protocol Changes and Ra9onale – 01/27/2020 
Major changes: 
1. The original version of this protocol was funded by the American Cancer Society. 
We also received funding for usability and a pilot study version of this proposed 
work from the Melanoma Research Alliance (protocol 
STUDY00002107/2018NTLS002). We nego.ated to combine the funding to 
support one larger study to increase our power for experience of sunburn during 
the interven.on period, a key secondary outcome. Therefore, we have increased 
the sample size here from 248 to 368 (184 each wave/summer) and we will 
formally close the previous pilot study with the CPRC, IRB and CT.gov and add the 
Melanoma Research Alliance as a funding source for this protocol. The PI 
discussed this plan of ac.on with Felicia Mroczkowski on 1/24/2020 who agreed 
this would likely be the best path from the IRB perspec.ve. 
2. Aier our usability tes.ng we have decided to switch to a diﬀerent wearable 
device than originally proposed. This device, Shade, was developed in 
collabora.on with the NIH NCI and has been shown to be signiﬁcantly more 
accurate than our previously proposed device. One disadvantage of this device is 
that it does not objec.vely measure physical ac.vity as the previous device did 
and therefore those pieces were removed from the protocol. We will rely on self-
report measures of physical ac.vity to test our secondary hypotheses related to 
physical ac.vity. Addi.onally, this device is signiﬁcantly more expensive than the 
previously planned device and therefore par.cipants will be asked to return the 
device at the end of the interven.on period and be provided gii cards 
throughout the study as incen.ve instead. They will be provided up to $120 in 
gii cards if they complete all study procedures ($20 baseline survey, $10 week 4 
survey, $10 week 8 survey, $60 return device and complete week 12 survey, $20 
complete week 64 survey). 
3. As this is a minimal risk study, we have removed the during-study monitoring of 
anxiety and depression. We have found in another study of cancer survivors that 
this monitoring and sending of leTers oien confuses and distresses par.cipants. 
We will plan, however, to examine whether rates of anxiety and/or depression 
rise during the interven.on period (week 12 vs. baseline) following Wave 1. 
While we do not expect that to be the case, should it happen we will proac.vely 
monitor in Wave 2.  
Minor changes: 
1. In addi.on to providing informa.on about poten.al barriers to sun protec.on to 
those in the interven.on via the website, we will also provide this informa.on in 
a paper brochure that has been reviewed with melanoma survivors as part of 
usability tes.ng. 
 
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PROTOCOL TITLE: Wearable device intervention to improve sun behaviors in 
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2. We ﬁnalized our survey measures. They are similar in topic to what was originally 
proposed but careful thought was put into reducing the number of items while 
maintaining focus on our primary and secondary objec.ves. Table 2 had been 
updated accordingly. 
3. Ini.al recruitment contact from the University of Minnesota will be via mail as 
opposed to phone. This change was made to ensure we have proper mailing 
addresses prior to sending the device and requires par.cipants to take one 
addi.onal step (return consent/HIPAA forms by mail) which we hope will 
translate to an increased chance they will return the device at the end of the 
study. 
4. We have clariﬁed that all recruitment will be done through HealthPartners; they 
will be the single site of recruitment. We also clariﬁed that HealthPartners will be 
reques.ng a waiver of consent to iden.fy poten.ally eligible par.cipants and a 
waiver of documenta.on of wriTen consent to provide contact informa.on to 
the University of Minnesota for those who verbally agree to par.cipate.  
5. We have provided all ﬁnal par.cipant communica.ons.
 
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