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Risk Information and Skin-cancer Education for Undergraduate Prevention (RISE-UP)

Primary Purpose

Melanoma, Young Adult

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MC1R Genetic Testing
Skin Cancer Education
UV Photo
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Melanoma focused on measuring Education Prevention, MC1R Genetic Testing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Individual is enrolled in courses at the University of Utah

And

  • Individual reports having had at least 1 sunburn in the past year

And/or

  • Individual reports having intentionally indoor or outdoor tanned at lease 1 time in the past year

And/or

- Individual reports using sunscreen plus 1 or more other 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

Sites / Locations

  • Huntsman Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Arm 1: Skin Cancer Education Only

Arm 2: Skin Cancer Education + UV Photo

Arm 3: Skin Cancer Education + MC1R Testing

Arm 4: Skin Cancer Education + UV Photo + MC1R Testing

Arm Description

Participants will be randomized to receive education only.

Participants randomized to receive education + UV photo will have a UV light photo taken of their face to show UV damage in the skin that is invisible to the naked eye in addition to receiving skin cancer education.

Participants randomized to receive education + genetic testing will be asked to provide a saliva sample for MC1R testing in addition to receiving skin cancer education.

Participants randomized to receive education + UV photo + genetic testing will have a UV light photo taken of their face, Submit a saliva sample for MC1R testing, and receive skin cancer education.

Outcomes

Primary Outcome Measures

Sun Protection Behaviors Assessed Via Questionnaires
Mean and standard deviation for each sun protection behavior at Visit 1 (baseline), Visit 2 (4 weeks), Visit 3 (8 weeks). "These next questions ask about what you have done in the past four weeks if you were outdoors in the sun for 15 minutes or more. How often did you... " Minimum value =1; Maximum value= 5; Higher scores indicate that participants were more likely to engage in sun protection habits.

Secondary Outcome Measures

Sunburn Occurrence Assessed Via Questionnaire
Average number of sunburns received by participants in the past 4 weeks when asked at Visit 1 (baseline), Visit 2 (4 weeks), and Visit 3 (8 weeks)
Intentional Outdoor Tanning Occurrence Assessed Via Questionnaire
Mean and standard deviation for intentional outdoor tanning occurrences at Visit 1 (baseline), Visit 2 (4 weeks), Visit 3 (8 weeks). "In the past 4 Weeks, how often did you spend time in the sun in order to get tan?" Minimum value =1; Maximum value= 5; Higher scores indicates that participants spent more time outdoors to get a tan.
Intentional Indoor Tanning Occurrence Assessed Via Questionnaire
Number of times participant used an indoor tanning device in the past 4 weeks when asked at Visit 1 (baseline), Visit 2 (4 weeks), and Visit 3 (8 weeks)
Tan Occurrence Assessed Via Questionnaire
Mean and standard deviation for tan occurrence at Visit 1 (baseline), Visit 2 (4 weeks), Visit 3 (8 weeks). "In the past 4 weeks, how often did you end up with a tan, even if you didn't try to get one?" Minimum value =1; Maximum value= 5; Higher scores indicate that participants received a tan as a result or being outdoors or using an indoor tanning device whether intentional or not.

Full Information

First Posted
June 5, 2019
Last Updated
July 9, 2021
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT03979872
Brief Title
Risk Information and Skin-cancer Education for Undergraduate Prevention
Acronym
RISE-UP
Official Title
Risk Information and Skin-cancer Education for Undergraduate Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
April 7, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study will be to provide undergraduate students information about skin cancer risk and prevention. The study will last between 2-3 months. Everyone in the study will be asked to answer questionnaires and receive education about skin cancer risk factors and prevention. We will follow-up with participants by phone, text messages or e-mail in between study visits Participants will be randomly assigned to one of four groups, the group will be in is decided by chance. Participant will either be assigned to: A group that gets advice about what causes skin cancer and how to prevent it A group that gets this advice and provides a saliva sample to receive personalized skin cancer risk genetic testing results A group that gets this advice and receives a personalized photo that shows existing skin damage A group that gets this advice, receives genetic testing results, and receives a personalized photo.
Detailed Description
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 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, 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 be 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). Molecular evaluation will be performed at the genetic, enzymatic (protein and RNA), and cellular response levels to identify melanoma predisposition genes. 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 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. After visit 3, participants will be offered the option to opt-in to receiving their raw genetic test report. 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). Molecular evaluation will be performed at the genetic, enzymatic (protein and RNA), and cellular response levels to identify melanoma predisposition genes. 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 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. After visit 3, participants will be offered the option to opt-in to receiving their raw genetic test report. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Young Adult
Keywords
Education Prevention, MC1R Genetic Testing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
4 different parallel intervention groups: Education only Education + MC1R genetic testing Education + UV photo Education + MC1R genetic testing + UV photo
Masking
Participant
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Skin Cancer Education Only
Arm Type
Active Comparator
Arm Description
Participants will be randomized to receive education only.
Arm Title
Arm 2: Skin Cancer Education + UV Photo
Arm Type
Experimental
Arm Description
Participants randomized to receive education + UV photo will have a UV light photo taken of their face to show UV damage in the skin that is invisible to the naked eye in addition to receiving skin cancer education.
Arm Title
Arm 3: Skin Cancer Education + MC1R Testing
Arm Type
Experimental
Arm Description
Participants randomized to receive education + genetic testing will be asked to provide a saliva sample for MC1R testing in addition to receiving skin cancer education.
Arm Title
Arm 4: Skin Cancer Education + UV Photo + MC1R Testing
Arm Type
Experimental
Arm Description
Participants randomized to receive education + UV photo + genetic testing will have a UV light photo taken of their face, Submit a saliva sample for MC1R testing, and receive skin cancer education.
Intervention Type
Diagnostic Test
Intervention Name(s)
MC1R Genetic Testing
Intervention Description
[See arm/group descriptions]
Intervention Type
Other
Intervention Name(s)
Skin Cancer Education
Intervention Description
[See arm/group descriptions]
Intervention Type
Device
Intervention Name(s)
UV Photo
Intervention Description
[See arm/group descriptions]
Primary Outcome Measure Information:
Title
Sun Protection Behaviors Assessed Via Questionnaires
Description
Mean and standard deviation for each sun protection behavior at Visit 1 (baseline), Visit 2 (4 weeks), Visit 3 (8 weeks). "These next questions ask about what you have done in the past four weeks if you were outdoors in the sun for 15 minutes or more. How often did you... " Minimum value =1; Maximum value= 5; Higher scores indicate that participants were more likely to engage in sun protection habits.
Time Frame
Weeks 0 (Visit 1), 4 (Visit 2), 8 (Visit 3)
Secondary Outcome Measure Information:
Title
Sunburn Occurrence Assessed Via Questionnaire
Description
Average number of sunburns received by participants in the past 4 weeks when asked at Visit 1 (baseline), Visit 2 (4 weeks), and Visit 3 (8 weeks)
Time Frame
Weeks 0 (Visit 1), 4 (Visit 2), 8 (Visit 3)
Title
Intentional Outdoor Tanning Occurrence Assessed Via Questionnaire
Description
Mean and standard deviation for intentional outdoor tanning occurrences at Visit 1 (baseline), Visit 2 (4 weeks), Visit 3 (8 weeks). "In the past 4 Weeks, how often did you spend time in the sun in order to get tan?" Minimum value =1; Maximum value= 5; Higher scores indicates that participants spent more time outdoors to get a tan.
Time Frame
Weeks 0 (Visit 1), 4 (Visit 2), 8 (Visit 3)
Title
Intentional Indoor Tanning Occurrence Assessed Via Questionnaire
Description
Number of times participant used an indoor tanning device in the past 4 weeks when asked at Visit 1 (baseline), Visit 2 (4 weeks), and Visit 3 (8 weeks)
Time Frame
Weeks 0 (Visit 1), 4 (Visit 2), 8 (Visit 3)
Title
Tan Occurrence Assessed Via Questionnaire
Description
Mean and standard deviation for tan occurrence at Visit 1 (baseline), Visit 2 (4 weeks), Visit 3 (8 weeks). "In the past 4 weeks, how often did you end up with a tan, even if you didn't try to get one?" Minimum value =1; Maximum value= 5; Higher scores indicate that participants received a tan as a result or being outdoors or using an indoor tanning device whether intentional or not.
Time Frame
Weeks 0 (Visit 1), 4 (Visit 2), 8 (Visit 3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individual is enrolled in courses at the University of Utah And Individual reports having had at least 1 sunburn in the past year And/or Individual reports having intentionally indoor or outdoor tanned at lease 1 time in the past year And/or - Individual reports using sunscreen plus 1 or more other 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yelena Wu, PHD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36306029
Citation
Wu YP, Hamilton JG, Kaphingst KA, Jensen JD, Kohlmann W, Parsons BG, Lillie HM, Wang X, Haaland B, Wankier AP, Grossman D, Hay JL. Increasing Skin Cancer Prevention in Young Adults: the Cumulative Impact of Personalized UV Photography and MC1R Genetic Testing. J Cancer Educ. 2023 Jun;38(3):1059-1065. doi: 10.1007/s13187-022-02232-1. Epub 2022 Oct 28.
Results Reference
derived

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Risk Information and Skin-cancer Education for Undergraduate Prevention

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