Ignite Creation Date:
2024-05-06 @ 6:22 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05634252
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2022-11-21
Brief Title:
Undergraduate Skin Cancer Prevention Trial
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Risk Information and Skin-Cancer Education and Undergraduate Prevention Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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 proposed study is a Multiphase Optimization Strategy MOST that uses factorial experiments to evaluate individual and combined effects of intervention components to improve intervention efficiency The study team anticipates enrolling a total of 528 undergraduate students 18 years into the trial to identify intervention approaches that eliminate sunburn and secondarily to motivate sun protection and discourage tanning The study team will test personalized risk components 1 UV Photo 2 Action Plan and 3 MC1R Testing A full factorial experiment will be conducted to test which of the proposed components or their combinations eliminate sunburn over one year The study team will also examine effects of the intervention on secondary outcomes Study assessments will be completed at 4 time points baseline 1-month post-intervention 4-months post-intervention and 15-months post-intervention
Detailed Description:
The proposed study is a Multiphase Optimization Strategy MOST that uses factorial experiments to evaluate individual and combined effects of intervention components to improve intervention efficiency The study team will use MOST to test an intervention that has the potential to eliminate sunburn in higher-risk young people during the highest risk times of the year The study will enroll a total of 528 undergraduate students 18 years total in Years 1 through 4 of the award period
After students provide informed consent they will complete a baseline assessment via the REDCap data capture system on their sunburn occurrence sun protection behaviors and tanning behaviors Following the baseline assessment students will be randomized to each group using computer-generated randomly permuted blocks stratified by sex and unintentionalintentional tanning There are three intervention components that are candidates for inclusion in the optimized RISE-UP intervention 1 UV Photo 2 Action Plan and 3 MC1R Testing All conditions will receive education on skin cancer and strategies to prevention skin cancer including sun protection strategies and avoidance of intentional and unintentional tanning
The optimized intervention will take place approximately one month after the baseline assessment Participants allocated to receive the UV photo will receive a printout photo of their face in visible light and UV light from the VISIA Complexion Analysis system Participants who receive the action plan will complete an individualized sun protection and tanning plan for situations in which they receive ultraviolet radiation UVR exposure Participants who are allocated to receive MC1R testing will be asked to provide a saliva sample Once sequenced participants will receive their results that addresses both their personal and population risk level
One month after the optimized intervention participants will be asked to complete another assessment Participants will also be asked to complete an additional follow-up assessment 3 months later and at 15-months post-intervention In total participants will be asked to complete 4 separate assessments Participants will also be asked to wear a UVR monitoring device for 7-day periods immediately after each of the 4 assessments
After students provide informed consent they will complete a baseline assessment via the REDCap data capture system on their sunburn occurrence sun protection behaviors and tanning behaviors Following the baseline assessment students will be randomized to each group using computer-generated randomly permuted blocks stratified by sex and unintentionalintentional tanning There are three intervention components that are candidates for inclusion in the optimized RISE-UP intervention 1 UV Photo 2 Action Plan and 3 MC1R Testing All conditions will receive education on skin cancer and strategies to prevention skin cancer including sun protection strategies and avoidance of intentional and unintentional tanning
The optimized intervention will take place approximately one month after the baseline assessment Participants allocated to receive the UV photo will receive a printout photo of their face in visible light and UV light from the VISIA Complexion Analysis system Participants who receive the action plan will complete an individualized sun protection and tanning plan for situations in which they receive ultraviolet radiation UVR exposure Participants who are allocated to receive MC1R testing will be asked to provide a saliva sample Once sequenced participants will receive their results that addresses both their personal and population risk level
One month after the optimized intervention participants will be asked to complete another assessment Participants will also be asked to complete an additional follow-up assessment 3 months later and at 15-months post-intervention In total participants will be asked to complete 4 separate assessments Participants will also be asked to wear a UVR monitoring device for 7-day periods immediately after each of the 4 assessments
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