Ignite Creation Date:
2024-05-06 @ 1:16 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03979872
Status:
COMPLETED
Last Update Posted:
2021-07-13
First Post:
2019-06-05
Brief Title:
Risk Information and Skin-cancer Education for Undergraduate Prevention
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Risk Information and Skin-cancer Education for Undergraduate Prevention
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RISE-UP
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
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 eg 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 eg 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 emailStudy 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 eg 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 eg sunscreen protective clothing and avoiding tanning and sunburns Participants will be provided with their personalized risk feedback based on their personalized photo showing their skins 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 emailStudy 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 eg 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 eg 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 eg 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 emailStudy 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 eg 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 eg 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 eg 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
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 eg 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 eg 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 emailStudy 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 eg 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 eg sunscreen protective clothing and avoiding tanning and sunburns Participants will be provided with their personalized risk feedback based on their personalized photo showing their skins 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 emailStudy 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 eg 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 eg 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 eg 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 emailStudy 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 eg 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 eg 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None