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VERSION DATE: 07/19/2021  
| 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                                       | Cancer Protocol Review CommiTee (CPRC)                                                                                                      |
| Assessment IND/IDE # (if                        | N/A                                                                                                                                         |
| applicable) IND/IDE Holder                      | N/A                                                                                                                                         |
| Inves9ga9onal Drug  Services # (if  applicable) | N/A                                                                                                                                         |
| Version Number/                                 | Version 3.2                                                                                                                                 |
| Date:                                           | PROTOCOL COVER PAGE                                                                                                                         |
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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                                                                                                                                                                                                                 | N                 |
| 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. |                |                                                                                                                                                                                                                                                                                     |                   |  
VERSION DATE: 07/19/2021 VERSION DATE: 07/19/2021
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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 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 twosample 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 Chisquared 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 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 VERSION DATE: 07/19/2021
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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                                |  
VERSION DATE: 07/19/2021
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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 UVRsensor wearable device interven.on to improve sun protec.on behaviors and reduce UV exposure and sunburns in a randomized controlled trial in melanoma survivors.
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2. background 2.1. significance of

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.
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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. VERSION DATE: 07/19/2021 In 2009, we completed the Skin Health Study (NIH/NCI R01), a popula.onbased 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 prediagnosis 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 VERSION DATE: 07/19/2021  
 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 VERSION DATE: 07/19/2021 as Co-Inves.gator on an industry-funded pilot project using Internetenabled 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.
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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.
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3. study endpoints/events/outcomes 3.1. primary

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 4point ordinal scale ranging from 1 = rarely or never to 4 = always. This has been used previously in similar interven.on studies 19
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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) 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.
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4. study interven9on 4.1. conceptual

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. VERSION DATE: 07/19/2021
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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  
| 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." Think about the feelings you  associate with being tan? Are there  other ways to generate those  feelings without tanning? "I feel lei out if  I'm not in the sun  with my friends/ family." The sun causes more than 90  percent of the visible changes  commonly aTributed to skin  aging 30. 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  reduce risk of a new melanoma  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  Vitamin 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  melanoma." 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 as a 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  past." 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.   |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|  
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.oncontrol group was chosen over no interven.on for a few reasons; one, we 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.
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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
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5. procedures involved 5.1. study

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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5.2. study procedures -randomized controlled

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. 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                                                                            | #  | 0   | 4  | 8  | 12    | 64  |
| Items                                         |                                                                                         |                                                                                        |    |     |    |    |       |     |
| Health                                        | Distraction                                                                             | Measures of healthy                                                                    |    |     |    |    |       |     |
| behaviors                                     | behaviors, including  alcohol, smoking, fruits,  vegetables, vitamin D,  height, weight | 10                                                                                     | X  | X   | X  | X  | X     |     |
| Physical                                      | Secondary                                                                               |                                                                                        |    |     |    |    |       |     |
| activity                                      | 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                                | Primary                                                                                 | Use of sunscreen, hat, shirt                                                           |    |     |    |    |       |     |
| Habits                                        | outcome                                                                                 | 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** |  
| Beliefs,  Intentions,  Self-Efficacy  regarding sun  protection  behaviors   | Substudy (if  intervention  fails)           | Reasoned Action Battery:  Intention, Attitude,  Behavioral beliefs,  Normative pressure,  Normative beliefs, Selfefficacy                                                                                                                          | 84   | X   | X   | X   |
|------------------------------------------------------------------------------|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|------|-----|-----|-----|
| (60)                                                                         | (60)                                         |                                                                                                                          |      |     |     |     |
| Sun protection                                                               | Secondary                                    |                                                                                                                          |      |     |     |     |
| knowledge                                                                    | 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                                                                | Background/                                  |                                                                                                                          |      |     |     |     |
| treatment                                                                    | Potential  moderators                        | Year diagnosis, location,  stage, treatments received,  recurrence, metastasis                                           | 18   | X   |     |     |
| Fear of                                                                      | Background/                                  |                                                                                                                          |      |     |     |     |
| recurrence                                                                   | 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                                                                       | 17                                           | X                                                                                                                        |      |     |     |     |
| satisfaction Total number of items                                           | 198                                          | 51                                                                                                                       | 51   | 167 | 141 |     |
| * Time frame: past 4 weeks                                                   | ** Time frame: past summer                   |                                                                                                                          |      |     |     |     |
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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).
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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 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
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6. data and specimen banking

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.
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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. 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.
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6.3. release/sharing

Data collected in this study will not be released or shared to those outside of the research team.
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7. sharing of results with

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.
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8. study popula9on 8.1. inclusion

- 18-75 years old 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
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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 (2010forward). 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.
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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.   |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|  
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                                                                                                                                                                                                                                 | Included/Allowed to Par.cipate |
| social group 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 |  
| 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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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.
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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
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11. local recruitment methods 11.1.

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 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 communica.on. VERSION DATE: 07/19/2021
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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.
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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.
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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 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.
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12. withdrawal of par9cipants 12.1.

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.
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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.
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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.
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13. risks to par9cipants 13.1.

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. VERSION DATE: 07/19/2021 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
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14. poten9al benefits to par9cipants

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.
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15. sta9s9cal considera9ons 15.1. data

All ques.onnaires have been previously developed and implemented and will be scored using standard methods.
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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. VERSION DATE: 07/19/2021 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 postcomple.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 VERSION DATE: 07/19/2021 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-totreat (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 randomthat 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.
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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.
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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.
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17. provisions to monitor the

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.
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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).
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18. provisions to protect the

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 VERSION DATE: 07/19/2021 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.
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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.
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20. consent process 20.1. consent

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 device directly from REDCap. VERSION DATE: 07/19/2021 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
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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
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22. mul9-site research n/a 23.

VERSION DATE: 07/19/2021 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.
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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 VERSION DATE: 07/19/2021 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.
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medical school department of obstetrics

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 VERSION DATE: 07/19/2021 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 industrysponsored 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 postaward grants managers and administra.ve assistants. These local services VERSION DATE: 07/19/2021 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.
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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, ParkNicollet/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 interdisciplinary 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 VERSION DATE: 07/19/2021 2016 on the East Bank of the University of Minnesota Medical Center campus.
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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.
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sph - division of epidemiology

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. VERSION DATE: 07/19/2021 Dr. Lazovich has dedicated office space and support from Division administra.ve staff.
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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.
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school of journalism and mass

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-ofthe-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 gameplaying devices for use in game simula.on research. As a member of the VERSION DATE: 07/19/2021 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 customconfigurable 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 Eprime 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.
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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 VERSION DATE: 07/19/2021 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 VERSION DATE: 07/19/2021 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.
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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 topranked 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: 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)** VERSION DATE: 07/19/2021 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 VERSION DATE: 07/19/2021 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.
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the ins.tute's research methodology group

methodological and sta.s.cal ac.vi.es associated with internally and externally funded projects. RMG consists of four PhD-level and two masterlevel 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.  
methodological and sta.s.cal ac.vi.es associated with internally and externally funded projects. RMG consists of four PhD-level and two masterlevel methodologists. The group exper.se includes epidemiologic methods, compara.ve effec.veness research, causal inference, biosta.s.cs, and VERSION DATE: 07/19/2021 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 inperson 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 mixedmode)
- 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 VERSION DATE: 07/19/2021 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 VERSION DATE: 07/19/2021 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 VERSION DATE: 07/19/2021 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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untitled h1
appendix summary of protocol 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 selfreport 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.
untitled h1
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. VERSION DATE: 07/19/2021 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.