- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03979872
Risk Information and Skin-cancer Education for Undergraduate Prevention (RISE-UP)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm 1: Skin Cancer Education Only
Participants will be randomized to receive education only.
|
[See arm/group descriptions]
|
Experimental: Arm 2: Skin Cancer Education + UV Photo
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.
|
[See arm/group descriptions]
[See arm/group descriptions]
|
Experimental: Arm 3: Skin Cancer Education + MC1R Testing
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.
|
[See arm/group descriptions]
[See arm/group descriptions]
|
Experimental: Arm 4: Skin Cancer Education + UV Photo + MC1R Testing
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.
|
[See arm/group descriptions]
[See arm/group descriptions]
[See arm/group descriptions]
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Weeks 0 (Visit 1), 4 (Visit 2), 8 (Visit 3)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sunburn Occurrence Assessed Via Questionnaire
Time Frame: Weeks 0 (Visit 1), 4 (Visit 2), 8 (Visit 3)
|
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)
|
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)
|
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. |
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)
|
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)
|
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)
|
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. |
Weeks 0 (Visit 1), 4 (Visit 2), 8 (Visit 3)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB_00116807
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Melanoma
-
H. Lee Moffitt Cancer Center and Research InstituteTurnstone Biologics, Corp.RecruitingMetastatic Melanoma | Conjunctival Melanoma | Ocular Melanoma | Unresectable Melanoma | Uveal Melanoma | Cutaneous Melanoma | Mucosal Melanoma | Iris Melanoma | Acral Melanoma | Non-Cutaneous MelanomaUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Mucosal Melanoma | Ciliary Body and Choroid Melanoma, Medium/Large Size | Ciliary Body and Choroid Melanoma, Small Size | Iris Melanoma | Metastatic Intraocular Melanoma | Recurrent Intraocular Melanoma | Stage IV Intraocular Melanoma | Stage IIIA Melanoma | Stage... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Stage IIB Melanoma | Stage IIC Melanoma | Stage IA Melanoma | Stage IB Melanoma | Stage IIA MelanomaUnited States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); University of VirginiaCompletedStage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage III Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin Melanoma | Stage 0 Skin Melanoma | Stage I Skin Melanoma | Stage II Skin MelanomaUnited States
-
MelanomaPRO, RussiaRecruitingMelanoma | Melanoma (Skin) | Melanoma Stage IV | Melanoma Stage III | Melanoma, Stage II | Melanoma, Uveal | Melanoma in Situ | Melanoma, OcularRussian Federation
-
Mayo ClinicNational Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Stage IIB Melanoma | Stage IIC Melanoma | Stage IIA MelanomaUnited States
-
National Cancer Institute (NCI)CompletedStage IV Melanoma | Ciliary Body and Choroid Melanoma, Medium/Large Size | Iris Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Extraocular Extension Melanoma | Stage IIB Melanoma | Stage IIC MelanomaUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); National Comprehensive Cancer NetworkTerminatedRecurrent Melanoma | Stage IV Melanoma | Metastatic Intraocular Melanoma | Recurrent Intraocular Melanoma | Stage IV Intraocular Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Extraocular Extension Melanoma | Stage IIIA Intraocular Melanoma | Stage IIIB Intraocular Melanoma | Stage...United States
-
BiocadRecruitingMelanoma | Melanoma (Skin) | Melanoma Stage IV | Melanoma Stage III | Melanoma Metastatic | Melanoma Unresectable | Melanoma AdvancedIndia, Russian Federation, Belarus
-
Emory UniversityGenentech, Inc.Active, not recruitingStage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Unresectable Melanoma | Stage III Melanoma | Stage IIIA Skin Melanoma | Cutaneous Melanoma, Stage III | Cutaneous Melanoma, Stage IVUnited States
Clinical Trials on Skin Cancer Education
-
Fox Chase Cancer CenterNational Cancer Institute (NCI)CompletedSkin NeoplasmsUnited States
-
Association of Dermatological Prevention, GermanyUniversity of Alberta; University of CalgaryUnknownMelanoma | Basal Cell Carcinoma | Squamous Cell Carcinoma | Skin TumorsCanada
-
Duke UniversityCancer and Leukemia Group B; Durham VA Medical CenterCompletedSmoking Cessation | Tobacco Use Disorder | Lung CancerUnited States
-
Momentum DataPfizerCompletedVitiligo | Melanoma (Skin) | Actinic Keratoses | Basal Cell Carcinoma | Squamous Cell Carcinoma | Nonmelanoma Skin CancerUnited Kingdom
-
Kutahya Health Sciences UniversityAtatürk UniversityCompletedBreastfeeding | Infant Development | PostpartumTurkey
-
National Cheng Kung UniversityCompleted
-
Thaddeus PaceCompletedCancer Survivors | Informal Cancer Caregivers (Family and Friends of Cancer Survivors)United States
-
Melanoma and Skin Cancer Trials LimitedMonash UniversityCompletedSkin Cancer | Melanoma (Skin)Australia
-
Harvard School of Public Health (HSPH)American Academy of Dermatology (AAD)Completed
-
Georgetown UniversityU.S. Army Medical Research and Development CommandCompleted