Undergraduate Skin Cancer Prevention Trial
RISE-UP
Risk Information and Skin-Cancer Education and Undergraduate Prevention Trial
1 other identifier
interventional
528
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2023
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2022
CompletedFirst Posted
Study publicly available on registry
December 2, 2022
CompletedStudy Start
First participant enrolled
April 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
December 13, 2024
December 1, 2024
4.1 years
November 21, 2022
December 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Sunburn Occurrence
Participants will report on the number of sunburns they experienced using an item from the Sun Habits Survey: "In the past month, how many times did you have a red or painful sunburn that lasted a day or more?"
Baseline, 1-month post-intervention, 3-months post-intervention, 15-months post-intervention
Secondary Outcomes (4)
Change in Sun Protection Behaviors
Baseline, 1-month post-intervention, 3-months post-intervention, 15-months post-intervention
Change in Intentional Tanning Behaviors
Baseline, 1-month post-intervention, 3-months post-intervention, 15-months post-intervention
Change in Unintentional Tanning Behaviors
Baseline, 1-month post-intervention, 3-months post-intervention, 15-months post-intervention
Change in UVR Exposure
Baseline, 1-month post-intervention, 3-months post-intervention, 15-months post-intervention
Study Arms (8)
Education + Action Plan + UV Photo + MC1R Test
EXPERIMENTALStudents in this intervention will receive education on skin cancer and prevention strategies, complete an individualized sun protection and tanning worksheet for situations in which they receive UVR exposure, receive a printout of a photo of their face in visible light and UV light from the VISIA Complexion Analysis system, and provide a saliva sample using an Oragene® clinical-grade saliva kit and receive individualized results following MC1R sequencing.
Education + Action Plan + UV Photo
EXPERIMENTALStudents in this intervention will receive education on skin cancer and prevention strategies, complete an individualized sun protection and tanning worksheet for situations in which they receive UVR exposure, and receive a printout of a photo of their face in visible light and UV light from the VISIA Complexion Analysis system.
Education + Action Plan + MC1R Test
EXPERIMENTALStudents in this intervention will receive education on skin cancer and prevention strategies, complete an individualized sun protection and tanning worksheet for situations in which they receive UVR exposure, and provide a saliva sample using an Oragene® clinical-grade saliva kit and receive individualized results following MC1R sequencing.
Education + Action Plan
EXPERIMENTALStudents in this intervention will receive education on skin cancer and prevention strategies and complete an individualized sun protection and tanning worksheet for situations in which they receive UVR exposure.
Education + UV Photo + MC1R Test
EXPERIMENTALStudents in this intervention will receive education on skin cancer and prevention strategies, receive a printout of a photo of their face in visible light and UV light from the VISIA Complexion Analysis system, and provide a saliva sample using an Oragene® clinical-grade saliva kit and receive individualized results following MC1R sequencing.
Education + UV Photo
EXPERIMENTALStudents in this intervention will receive education on skin cancer and prevention strategies and receive a printout of a photo of their face in visible light and UV light from the VISIA Complexion Analysis system.
Education + MC1R Test
EXPERIMENTALStudents in this intervention will receive education on skin cancer and prevention strategies and provide a saliva sample using an Oragene® clinical-grade saliva kit and receive individualized results following MC1R sequencing.
Education
EXPERIMENTALStudents in this intervention will receive education on skin cancer and prevention strategies.
Interventions
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.
Participants will be guided through a worksheet for creating a personalized action plan for creating individualized sun protection and tanning plans for situations in which they receive UVR exposure. For the tanning worksheet, participants who report any tanning identify the locations at or activities during which they tan, select a tanning behavior to plan for, and then are guided through the steps of making a specific plan for an alternate activity that meets their goals while minimizing tanning and using sun protection.
Participants will receive a printout of a photo of their face in visible light and UV light from the VISIA Complexion Analysis system. Participants will receive a handout of their photos accompanied by an explanation of UV light, its harmful effects on skin, and that using sun safe behaviors early in life will have the greatest impact and help to decrease risk for skin cancer.
Participants will provide a saliva sample using an Oragene® clinical-grade saliva kit. Once sequenced, participants will receive their MC1R testing results via web as well as a standardized booklet that addresses personal risk level and population risk level, strategies to reduce skin cancer risk, and number to call or email for further information.
Eligibility Criteria
You may qualify if:
- At least 18 years old
- Enrolled as an undergraduate student
- Report having at least one sunburn in the last year, AND/OR having tanned indoors at least once in the last year, AND/OR intentional or unintentional outdoor tanning "sometimes," "often," or "always," AND/OR or using sunscreen plus one or more other sun protection behavior (protective clothing use, shade use when outdoors) infrequently ("never," "seldom," or "sometimes").
You may not qualify if:
- Do not read or speak English
- Self-reported personal history of skin cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Related Publications (1)
Wu YP, Woodside LA, Kaphingst KA, Jensen JD, Hamilton JG, Kohlmann W, Haaland B, Brintz BJ, Phillips SM, Hay JL. The Risk Information and Skin-cancer Education for Undergraduate Prevention (RISE-UP) Study: Protocol for a Trial of Personalized Sun Protection Interventions for Skin Cancer Prevention among Undergraduate Students. Contemp Clin Trials. 2024 Dec;147:107728. doi: 10.1016/j.cct.2024.107728. Epub 2024 Nov 2.
PMID: 39491719DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yelena Wu, PhD
University of Utah
- PRINCIPAL INVESTIGATOR
Jennifer Hay, PhD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Investigator
Study Record Dates
First Submitted
November 21, 2022
First Posted
December 2, 2022
Study Start
April 24, 2023
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
December 13, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share