Risk Information and Skin-cancer Education for Undergraduate Prevention
Phase: NA
Conditions: Melanoma, Young Adult
Sponsor: University of Utah

 
Protocol Summary (ERICA) 
 
IRB_00116807 
Page 1 of 8 
 
IRB Approval 3/24/2021 
 
 
RISE-UP (Risk Information and Skin-cancer Education for 
Undergraduate Prevention) 
 
 
Protocol Summary 
 
 
 
IRB Approval 
Date of 
Current 
Version: 
3/24/2021 
University of 
Utah IRB #: 
IRB_00116807 
Sponsor: DERMATOLOGY 
  
Principal 
Investigator: 
Yelena Wu 
Internal Staff 
and  Sub-
Investigators: 
Site Name 
Staff Names 
University of Utah Yelena Wu 
 
Hannah Brady 
 
Helen Lillie 
 
Benjamin Haaland 
 
Wendy Kohlmann 
 
Nic Siniscalchi 
 
Kadyn Kimball 
 
Ali Palmer 
 
Xuechen Wang 
 
Jakob Jensen 
 
This document was created using the ERICA Online System at the University of Utah. The document is created 
from study information approved by the IRB on the date listed above.  Any alteration to the original content of this 
document may not be considered to represent the study as approved by the IRB.  
 
 

 
Protocol Summary (ERICA) 
 
IRB_00116807 
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IRB Approval 3/24/2021 
 
Background and Introduction 
 
Skin cancer is the most commonly diagnosed cancer in the United States.1 Melanoma is the 
most deadly form of skin cancer, and the incidence of melanoma in Utah is the highest in the 
U.S.2,3 Although skin cancers typically onset in the later adult years, it is becoming 
increasingly diagnosed among young adults.4 Efforts to decrease ultraviolet radiation (UVR) 
exposure, the main risk factor for development of skin cancer, should start early in life.5 
Prior research indicates that college students are at high risk for engaging in unintentional and 
intentional tanning behaviors that dramatically increase their UVR exposure and that they use 
inadequate sun protection strategies when they are outdoors.6,7 However, few studies have 
examined novel strategies to improve college students’ use of sun protection and decrease their 
intentional tanning behaviors.8,9 Prior studies have shown that traditional risk communication 
strategies do not effectively change college students’ health behaviors.10,11 It is possible that 
college students require more novel forms of risk information in order to motivate behavior 
change, and that these new forms of risk information should be grounded in established 
theoretical models. In the current study, we will test several theoretically-driven risk 
communication strategies that aim to improve college students’ engagement in skin cancer 
prevention behaviors, including sun protection behaviors (sunscreen, protective clothing, 
shade, peak UVR hours avoidance) and tanning behaviors (indoor, outdoor, unintentional). 
Based on prior literature,12 we anticipate low levels of distress regarding MC1R feedback. In 
the current study, we will test several theoretically-driven risk communication strategies that 
aim to improve college students’ engagement in skin cancer prevention behaviors, including 
sun protection behaviors (sunscreen, protective clothing, shade, peak UVR hours avoidance) 
and tanning behaviors (indoor, outdoor, unintentional). 
 
 
 
Purpose and Objectives 
 
The purpose of this study is to test the feasibility of providing young people with skin cancer 
prevention education and/or personalized feedback on their risk for skin cancer using novel 
methods of communicating this risk. In addition, we will examine the effects that the 
education and risk feedback have on individuals’ reported sun protection and tanning 
behaviors. 
 
 
 
Study Population 
 
Age of Participants: 18+ 
 
Sample Size: 
At Utah: 
300  

 
Protocol Summary (ERICA) 
 
IRB_00116807 
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IRB Approval 3/24/2021 
 
All Centers: 
300 
 
Inclusion Criteria: 
Individual is enrolled in courses at the University of Utah 
And 
Individual reports having had at least 1 sunburn in past year 
And/or 
Individual reports having intentionally indoor or outdoor tanned at least 1 time in the past 
year 
And/or 
Individual reports using sunscreen plus 1 or more of the following behaviors 
never/rarely/sometimes in the past month: 1) Protective clothing items, 2) Shade when 
outdoors 
 
 
Exclusion Criteria: 
Individual does not read/speak English 
Individual reports a personal history of skin cancer 
 
 
Design  
 
Randomized Trial 
 
 
 
 
Study Procedures 
 
Recruitment/Participant Identification Process: 
1) Participants will be recruited through courses at the University of Utah (e.g., through 
Departments of Communication, Biology, Psychology) in which professors have agreed to 
offer extra credit in exchange for participation in this study. Professors will be contacted prior 
to recruitment to determine their willingness to offer extra credit. Information about the study 
may be made available to potential participants in these courses via in person contact, email, 
canvas, phone or text.  
2) Information will be made available in common areas on campus via flyers (e.g., in the 
student Union, through campus newspapers, email listservs) including study information 
and the study team's contact information for potential participants to get in touch if they want 
to participate. Potential participants will have the option to text the study phone number to be 

 
Protocol Summary (ERICA) 
 
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IRB Approval 3/24/2021 
 
screened, or complete an online screening form. Study staff may contact participants who 
screen to be eligible via phone, text, or email. 
3) Information about this study may be be available on the Huntsman Cancer Institute website 
and via social media postings (see advertisements attached). Patients who self-refer in 
response to these advertisements will receive a follow-up from the study team. 
 
 
Informed Consent: 
Description of location(s) where consent will be obtained:  
Consent will be obtained from the participant in-person at the University of Utah during visit 
1. 
 
Description of the consent process(es), including the timing of consent:  
1. Participants will be provided all of the required information about the study via the consent 
document. 2. We will give participants this information in a language they understand 
(English). We will use language that is simplified and appropriate for potential participants to 
understand. Participants that do not speak/read or write in English will be excluded from the 
study. 3. Participants will be given an opportunity to ask questions before they consent and to 
ensure that the individual has had enough time to review the consent form to before they sign 
the consent. The study staff will review the consent form with potential participants and be 
available to potential participants to ask any questions they may have. 4. Participants will be 
given time to review the consent and consider being in the study. If the participant wants to 
take more time to consider whether they want to participate in the study, study staff will 
schedule another time to complete the consent and visit 1 procedures with them. 5. We will 
use clear and easy to understand language in the consent document and will not include 
exculpatory language. 6. Consent will be documented by obtaining a signature from the 
participant, and study staff will keep the signed document in the research record. 7. 
Participants will receive a copy of their signed consent documents via email, mail, fax, or in 
person. 
 
Procedures: 
Arm 1: Skin Cancer Education Only 
Screening: Participants will have the option to complete and online or text based screening 
form. Study staff may contact participants who screen to be eligible via phone, text, or email. 
Study staff will screen potential participants who do not complete the screening form on their 
own for eligibility. Participants will be contacted by phone, text, or email (starting with the 
method they indicated would be best to reach them) to schedule their first study visit. 
Enrollment 
Visit 1: All participants who consent to participate will be asked to participate in up to 3 study 
visits approximately 4 weeks apart. At visit 1, all participants will be asked to complete 
informed consent procedures and a baseline questionnaire via computer (e.g., using 

 
Protocol Summary (ERICA) 
 
IRB_00116807 
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IRB Approval 3/24/2021 
 
Qualtrics) or paper. Participants will be randomized to receive education only, or varying 
combinations of the intervention components. 
Visit 2: At visit 2 participants will receive education on the importance of skin cancer 
prevention behaviors (e.g., sunscreen, protective clothing) and avoiding tanning and sunburns. 
All education will be delivered at this visit on a computer screen and additionally given to 
participants as a handout they can take home to review. When participants view the 
information on the computer screen, eye tracking will be used to assess participant response. 
Prior to viewing results, eye tracking equipment set up at the computer station will be 
calibrated. We will then put up their results on the screen and the imotion system will then 
track their pupillary movement, facial expression, and galvanic skin response (physiological 
arousal). Participants will be allowed as much time as they would like to review their results. 
Following this, participants will complete a post assessment. Participants will receive paper 
copies of all of the relevant information to take home with them. 
Visit 3: Visit 3 may be conducted remotely. At visit 3, participants will complete a follow-up 
assessment. 
Follow-up interview: A random sample of the participant population with be contacted to 
participate in a follow-up interview with study staff to answer questions about their experience 
participating in the RISE-UP study.  
Arm 2: Skin Cancer Education + UV Photo 
Screening: Participants will have the option to complete and online or text based screening 
form. Study staff may contact participants who screen to be eligible via phone, text, or 
email.Study staff will screen potential participants who do not complete the screening form on 
their own for eligibility. Participants will be contacted by phone, text, or email (starting with 
the method they indicated would be best to reach them) to schedule their first study visit. 
Enrollment 
Visit 1: All participants who consent to participate will be asked to participate in up to 3 study 
visits approximately 4 weeks apart. At visit 1, all participants will be asked to complete 
informed consent procedures and a baseline questionnaire via computer (e.g., using 
Qualtrics) or paper. Participants will be randomized to receive education only, or varying 
combinations of the intervention components. Participants randomized to the education + UV 
photo arm will have their UV light photo taken of their face to show UV damage in the skin 
that is invisible to the naked eye. Photos will be taken with the VISIA Facial Complexion 
Analysis System, which captures high resolution imagery at the far spectrum of UVA or long 
wave UV. 
Visit 2: At visit 2 participants will receive education on the importance of skin cancer 
prevention behaviors (e.g., sunscreen, protective clothing) and avoiding tanning and sunburns. 
Participants will be provided with their personalized risk feedback based on their personalized 
photo showing their skin’s existing UVR damage from UVR exposure. All information will be 
delivered at this visit on a computer screen and additionally given to participants as a handout 
they can take home to review. When participants view their results on the computer screen, 

 
Protocol Summary (ERICA) 
 
IRB_00116807 
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IRB Approval 3/24/2021 
 
eye tracking will be used to assess participant response. Prior to viewing results, eye tracking 
equipment set up at the computer station will be calibrated. We will then put up their results 
on the screen and the imotion system will then track their pupillary movement, facial 
expression, and galvanic skin response (physiological arousal). Participants will be allowed as 
much time as they would like to review their results. Following this, participants will complete 
a post assessment. The imagery resulting will be kept on file in a password protected 
computer. Participants will receive paper copies of all of the relevant information to take home 
with them. 
Visit 3: Visit 3 may be conducted remotely. At visit 3, participants will complete a follow-up 
assessment. 
Follow-up interview: A random sample of the participant population with be contacted to 
participate in a follow-up interview with study staff to answer questions about their experience 
participating in the RISE-UP study. 
Arm 3: Skin Cancer Education + MC1R Testing 
Screening: Participants will have the option to complete and online or text based screening 
form. Study staff may contact participants who screen to be eligible via phone, text, or 
email.Study staff will screen potential participants who do not complete the screening form on 
their own for eligibility. Participants will be contacted by phone, text, or email (starting with 
the method they indicated would be best to reach them) to schedule their first study visit. 
Enrollment 
Visit 1: All participants who consent to participate will be asked to participate in up to 3 study 
visits approximately 4 weeks apart. At visit 1, all participants will be asked to complete 
informed consent procedures and a baseline questionnaire via computer (e.g., using 
Qualtrics) or paper. Participants will be randomized to receive education only, or varying 
combinations of the intervention components. Participants randomized to the education + 
MC1R testing arm will be asked to provide a saliva sample. Saliva will be collected by study 
staff using a system for the collection, stabilization and transportation of DNA from 
saliva (e.g., Oragene DNA collection kits). Participants will be genotyped for SNPs in MC1R 
that have been associated with melanoma risk. Genotyping will be done through U of U core 
facilities 
Visit 2: At visit 2 participants will receive education on the importance of skin cancer 
prevention behaviors (e.g., sunscreen, protective clothing) and avoiding tanning and sunburns. 
Participants will be provided with their personalized risk feedback based on a summary of 
their MC1R genetic testing results. All information will be delivered at this visit on a 
computer screen and additionally given to participants as a handout they can take home to 
review. When participants view their results on the computer screen, eye tracking will be used 
to assess participant response. Prior to viewing results, eye tracking equipment set up at the 
computer station will be calibrated. We will then put up their results on the screen and the 
imotion system will then track their pupillary movement, facial expression, and galvanic skin 
response (physiological arousal). Participants will be allowed as much time as they would like 

 
Protocol Summary (ERICA) 
 
IRB_00116807 
Page 7 of 8 
 
IRB Approval 3/24/2021 
 
to review their results. Following this, participants will complete a post assessment. 
Participants will receive paper copies of all of the relevant information to take home with 
them. 
Visit 3: Visit 3 may be conducted remotely. At visit 3, participants will complete a follow-up 
assessment. Participants who have clinical questions about melanoma or concerns about their 
family history will be referred to speak with a genetic counselor or be referred to HCI’s 
Family Cancer Assessment Clinic (FCAC) for further information and information on CLIA 
testing. 
Follow-up interview: A random sample of the participant population with be contacted to 
participate in a follow-up interview with study staff to answer questions about their experience 
participating in the RISE-UP study.  
Arm 4: Skin Cancer Education + UV Photo + MC1R Testing 
Screening: Participants will have the option to complete and online or text based screening 
form. Study staff may contact participants who screen to be eligible via phone, text, or 
email.Study staff will screen potential participants who do not complete the screening form on 
their own for eligibility. Participants will be contacted by phone, text, or email (starting with 
the method they indicated would be best to reach them) to schedule their first study visit. 
Enrollment 
Visit 1: All participants who consent to participate will be asked to participate in up to 3 study 
visits approximately 4 weeks apart. At visit 1, all participants will be asked to complete 
informed consent procedures and a baseline questionnaire via computer (e.g., using 
Qualtrics) or paper. Participants will be randomized to receive education only, or varying 
combinations of the intervention components. Participants randomized to the education + UV 
photo + MC1R testing arm will have a UV light photo taken of their face to show UV damage 
in the skin that is invisible to the naked eye and will be asked to provide a saliva sample. 
Photos will be taken with the VISIA Facial Complexion Analysis System, which captures high 
resolution imagery at the far spectrum of UVA or long wave UV. Saliva will be collected by 
study staff using a system for the collection, stabilization and transportation of DNA from 
saliva (e.g., Oragene DNA collection kits). Participants will be genotyped for SNPs in MC1R 
that have been associated with melanoma risk. Genotyping will be done through U of U core 
facilities 
Visit 2: At visit 2 participants will receive education on the importance of skin cancer 
prevention behaviors (e.g., sunscreen, protective clothing) and avoiding tanning and sunburns. 
Participants will be provided with their personalized risk feedback based on a summary of 
their personalize UV photo and a summary of their MC1R genetic testing results. All 
information will be delivered at this visit on a computer screen and additionally given to 
participants as a handout they can take home to review. When participants view their results 
on the computer screen, eye tracking will be used to assess participant response. Prior to 
viewing results, eye tracking equipment set up at the computer station will be calibrated. We 
will then put up their results on the screen and the imotion system will then track their 

 
Protocol Summary (ERICA) 
 
IRB_00116807 
Page 8 of 8 
 
IRB Approval 3/24/2021 
 
pupillary movement, facial expression, and galvanic skin response (physiological arousal). 
Participants will be allowed as much time as they would like to review their results. Following 
this, participants will complete a post assessment. The imagery resulting will be kept on file in 
a password protected computer. Participants will receive paper copies of all of the relevant 
information to take home with them. 
Visit 3: Visit 3 may be conducted remotely. At visit 3, participants will complete a follow-up 
assessment. Participants who have clinical questions about melanoma or concerns about their 
family history will be referred to speak with a genetic counselor or be referred to HCI’s 
Family Cancer Assessment Clinic (FCAC) for further information and information on CLIA 
testing. 
Follow-up interview: A random sample of the participant population with be contacted to 
participate in a follow-up interview with study staff to answer questions about their experience 
participating in the RISE-UP study. 
 
 
Procedures performed for research purposes only:  
 
 
Statistical Methods, Data Analysis and Interpretation 
 
Descriptive statistics (number, percent for categorical variables and mean, standard deviation 
for quantitative variables) were calculated for demographic characteristics and participant’s 
sun protection and tanning outcomes. For inferential statistical analyses, missing data was 
handled via multiple imputation, which ensures valid inference under missingness-at-random 
(data values independent of missingness pattern, conditional on the observed data), the most 
general data-centered missing data assumption. Twenty complete data sets were generated and 
all statistical analyses were based on these, with pooling via Rubin’s rules. The primary 
outcomes of interest include sun protection and tanning. In order to estimate changes in 
outcomes over time overall and compare changes over time between the four intervention 
groups, generalized estimating equations (GEE) were used to account for repeated measures 
within individuals. Season of participation (fall versus spring) was considered an important 
factor for the primary outcomes, so it was included as an adjustment factor in all models and 
outcomes were also examined within each season separately.