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Undergraduate Skin Cancer Prevention Trial (RISE-UP)

Primary Purpose

Skin Cancer

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Education
Action Plan
UV Photo
MC1R Test
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Skin Cancer focused on measuring Young Adults, Sunburn, Tanning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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"). Exclusion Criteria: Do not read or speak English Self-reported personal history of skin cancer

Sites / Locations

  • Huntsman Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Education + Action Plan + UV Photo + MC1R Test

Education + Action Plan + UV Photo

Education + Action Plan + MC1R Test

Education + Action Plan

Education + UV Photo + MC1R Test

Education + UV Photo

Education + MC1R Test

Education

Arm Description

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.

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.

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.

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.

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.

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.

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.

Students in this intervention will receive education on skin cancer and prevention strategies.

Outcomes

Primary Outcome Measures

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?"

Secondary Outcome Measures

Change in Sun Protection Behaviors
Participants will report on their use of sun protection using the Sun Habits Survey. Items will be modified to reflect the reporting period relevant for the current study (past month), to assess recommended sun protection behaviors not included in the original Sun Habits Survey (e.g., sunscreen re-application), and to assess sun protection separately for weekdays and weekends. All items are assessed on a 5-point Likert-type scale ("never" to "always").
Change in Intentional Tanning Behaviors
Self-reported indoor and outdoor tanning behaviors will be assessed. Frequency of intentional indoor and outdoor tanning in the past month will be assessed using items from a well-established indoor tanning measure and the Sun Habits Survey. All items are assessed on a 5-point Likert-type scale ("never" to "always").
Change in Unintentional Tanning Behaviors
Unintentional outdoor tanning (i.e., ending up with a tan when the student was not trying to get tan) will also be assessed. All items are assessed on a 5-point Likert-type scale ("never" to "always").
Change in UVR Exposure
Participants will be asked to wear a UVR monitoring device for 7-day periods, a monitoring length consistent with prior studies and that captures both weekday and weekend exposure, immediately after each of the 4 assessments.

Full Information

First Posted
November 21, 2022
Last Updated
May 3, 2023
Sponsor
University of Utah
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05634252
Brief Title
Undergraduate Skin Cancer Prevention Trial
Acronym
RISE-UP
Official Title
Risk Information and Skin-Cancer Education and Undergraduate Prevention Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 24, 2023 (Actual)
Primary Completion Date
June 2027 (Anticipated)
Study Completion Date
June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Cancer
Keywords
Young Adults, Sunburn, Tanning

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
528 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Education + Action Plan + UV Photo + MC1R Test
Arm Type
Experimental
Arm Description
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.
Arm Title
Education + Action Plan + UV Photo
Arm Type
Experimental
Arm Description
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.
Arm Title
Education + Action Plan + MC1R Test
Arm Type
Experimental
Arm Description
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.
Arm Title
Education + Action Plan
Arm Type
Experimental
Arm Description
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.
Arm Title
Education + UV Photo + MC1R Test
Arm Type
Experimental
Arm Description
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.
Arm Title
Education + UV Photo
Arm Type
Experimental
Arm Description
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.
Arm Title
Education + MC1R Test
Arm Type
Experimental
Arm Description
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.
Arm Title
Education
Arm Type
Experimental
Arm Description
Students in this intervention will receive education on skin cancer and prevention strategies.
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Action Plan
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
UV Photo
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MC1R Test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Sunburn Occurrence
Description
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?"
Time Frame
Baseline, 1-month post-intervention, 3-months post-intervention, 15-months post-intervention
Secondary Outcome Measure Information:
Title
Change in Sun Protection Behaviors
Description
Participants will report on their use of sun protection using the Sun Habits Survey. Items will be modified to reflect the reporting period relevant for the current study (past month), to assess recommended sun protection behaviors not included in the original Sun Habits Survey (e.g., sunscreen re-application), and to assess sun protection separately for weekdays and weekends. All items are assessed on a 5-point Likert-type scale ("never" to "always").
Time Frame
Baseline, 1-month post-intervention, 3-months post-intervention, 15-months post-intervention
Title
Change in Intentional Tanning Behaviors
Description
Self-reported indoor and outdoor tanning behaviors will be assessed. Frequency of intentional indoor and outdoor tanning in the past month will be assessed using items from a well-established indoor tanning measure and the Sun Habits Survey. All items are assessed on a 5-point Likert-type scale ("never" to "always").
Time Frame
Baseline, 1-month post-intervention, 3-months post-intervention, 15-months post-intervention
Title
Change in Unintentional Tanning Behaviors
Description
Unintentional outdoor tanning (i.e., ending up with a tan when the student was not trying to get tan) will also be assessed. All items are assessed on a 5-point Likert-type scale ("never" to "always").
Time Frame
Baseline, 1-month post-intervention, 3-months post-intervention, 15-months post-intervention
Title
Change in UVR Exposure
Description
Participants will be asked to wear a UVR monitoring device for 7-day periods, a monitoring length consistent with prior studies and that captures both weekday and weekend exposure, immediately after each of the 4 assessments.
Time Frame
Baseline, 1-month post-intervention, 3-months post-intervention, 15-months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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"). Exclusion Criteria: Do not read or speak English Self-reported personal history of skin cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liberty Woodside
Phone
(801) 646-4351
Email
Liberty.Woodside@hci.utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yelena Wu, PhD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jennifer Hay, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liberty Woodside
Phone
734-881-5888
Email
Liberty.Woodside@hci.utah.edu
First Name & Middle Initial & Last Name & Degree
Yelena Wu, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Undergraduate Skin Cancer Prevention Trial

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