Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
528 participants
INTERVENTIONAL
2023-04-24
2027-06-30
Brief Summary
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Detailed Description
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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 unintentional/intentional 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
NONE
Study Groups
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Education + Action Plan + UV Photo + MC1R Test
Students 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
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.
Action Plan
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.
UV Photo
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.
MC1R Test
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.
Education + Action Plan + UV Photo
Students 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
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.
Action Plan
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.
UV Photo
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.
Education + Action Plan + MC1R Test
Students 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
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.
Action Plan
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.
MC1R Test
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.
Education + Action Plan
Students 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
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.
Action Plan
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.
Education + UV Photo + MC1R Test
Students 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
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.
UV Photo
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.
MC1R Test
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.
Education + UV Photo
Students 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
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.
UV Photo
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.
Education + MC1R Test
Students 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
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.
MC1R Test
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.
Education
Students in this intervention will receive education on skin cancer and prevention strategies.
Education
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.
Interventions
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Education
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.
Action Plan
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.
UV Photo
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.
MC1R Test
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
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Inclusion Criteria
* 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").
Exclusion Criteria
* Self-reported personal history of skin cancer
18 Years
ALL
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of Utah
OTHER
Responsible Party
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Yelena Wu
Associate Professor, Investigator
Principal Investigators
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Yelena Wu, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Jennifer Hay, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Huntsman Cancer Institute
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Benjamin Weitzman, B.S.
Role: primary
References
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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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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IRB_00157778
Identifier Type: -
Identifier Source: org_study_id