MelanomaRISE-UPNCT03979872
Risk Information and Skin-cancer Education for Undergraduate Prevention
A study testing MC1R Genetic Testing, Skin Cancer Education and UV Photo in people with Melanoma and Young Adult, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melanoma, Young Adult
- What is being tested?
- MC1R Genetic Testing, Skin Cancer Education and UV Photo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2019to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Individual does not read/speak English
- Individual reports a personal history of skin cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
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.
Read the 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.
- Conditions
- Melanoma, Young Adult
- Being tested
- MC1R Genetic Testing, Skin Cancer Education, UV Photo
- Keywords
- Education Prevention, MC1R Genetic Testing
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MC1R Genetic TestingDiagnostic test
[See arm/group descriptions]
Skin Cancer EducationOther
[See arm/group descriptions]
UV PhotoDevice
[See arm/group descriptions]
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Skin Cancer Education Only | Active comparator | Participants will be randomized to receive education only. Receives: Other: Skin Cancer Education |
| Arm 2: Skin Cancer Education + UV Photo | Experimental | 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. Receives: Other: Skin Cancer Education; Device: UV Photo |
| Arm 3: Skin Cancer Education + MC1R Testing | Experimental | 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. Receives: Diagnostic Test: MC1R Genetic Testing; Other: Skin Cancer Education |
| Arm 4: Skin Cancer Education + UV Photo + MC1R Testing | Experimental | 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. Receives: Diagnostic Test: MC1R Genetic Testing; Other: Skin Cancer Education; Device: UV Photo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weeks 0 (Visit 1), 4 (Visit 2), 8 (Visit 3)
Secondary outcomes (4)
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)
Measured: Weeks 0 (Visit 1), 4 (Visit 2), 8 (Visit 3)
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.
Measured: Weeks 0 (Visit 1), 4 (Visit 2), 8 (Visit 3)
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)
Measured: Weeks 0 (Visit 1), 4 (Visit 2), 8 (Visit 3)
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.
Measured: Weeks 0 (Visit 1), 4 (Visit 2), 8 (Visit 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start9 Sep 2019
- Primary completion7 Apr 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 4 different parallel intervention groups: * Education only * Education + MC1R genetic testing * Education + UV photo * Education + MC1R genetic testing + UV photo
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yelena Wu, University of Utah
- Investigators
- Yelena Wu, PHD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979872
- Sponsor's protocol ID
- IRB_00116807
- Acronym
- RISE-UP
- Status last verified
- Jul 2021
- First submitted
- 5 Jun 2019
- Last updated
- 13 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36306029
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Information and Skin-cancer Education for Undergraduate Prevention
- ClinicalTrials.gov ID
- NCT03979872
- Acronym / sponsor ID
- RISE-UP / IRB_00116807
- Conditions
- Melanoma, Young Adult
- Keywords
- Education Prevention, MC1R Genetic Testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 7 Apr 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 7 Jun 2019 (actual)
- Results
- Posted 1 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- 4 different parallel intervention groups: * Education only * Education + MC1R genetic testing * Education + UV photo * Education + MC1R genetic testing + UV photo
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Skin Cancer Education Only | Active comparator | Other: Skin Cancer EducationParticipants will be randomized to receive education only. |
| Arm 2: Skin Cancer Education + UV Photo | Experimental | Other: Skin Cancer Education, Device: UV PhotoParticipants 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 3: Skin Cancer Education + MC1R Testing | Experimental | Diagnostic Test: MC1R Genetic Testing, Other: Skin Cancer EducationParticipants 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 4: Skin Cancer Education + UV Photo + MC1R Testing | Experimental | Diagnostic Test: MC1R Genetic Testing, Other: Skin Cancer Education, Device: UV PhotoParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Individual does not read/speak English
- Individual reports a personal history of skin cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MC1R Genetic Testing[See arm/group descriptions] | Diagnostic test | Arm 3: Skin Cancer Education + MC1R Testing, Arm 4: Skin Cancer Education + UV Photo + MC1R Testing |
| Skin Cancer Education[See arm/group descriptions] | Other | 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 |
| UV Photo[See arm/group descriptions] | Device | Arm 2: Skin Cancer Education + UV Photo, Arm 4: Skin Cancer Education + UV Photo + MC1R Testing |
Primary outcome
Sun Protection Behaviors Assessed Via Questionnaires
Time frame: Weeks 0 (Visit 1), 4 (Visit 2), 8 (Visit 3)
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.
4 secondary outcomes
Sunburn Occurrence Assessed Via Questionnaire
Time frame: Weeks 0 (Visit 1), 4 (Visit 2), 8 (Visit 3)
Intentional Outdoor Tanning Occurrence Assessed Via Questionnaire
Time frame: Weeks 0 (Visit 1), 4 (Visit 2), 8 (Visit 3)
Intentional Indoor Tanning Occurrence Assessed Via Questionnaire
Time frame: Weeks 0 (Visit 1), 4 (Visit 2), 8 (Visit 3)
Tan Occurrence Assessed Via Questionnaire
Time frame: Weeks 0 (Visit 1), 4 (Visit 2), 8 (Visit 3)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36306029Wu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yelena Wu, PHD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MC1R Genetic Testing, Skin Cancer Education and UV Photo in people with Melanoma and Young Adult, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sun Protection Behaviors Assessed Via Questionnaires (time frame: Weeks 0 (Visit 1), 4 (Visit 2), 8 (Visit 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03979872, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2021.