Risk Information and Skin-Cancer Education and Undergraduate Prevention Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 528
- 试验地点
- 1
- 主要终点
- Change in Sunburn Occurrence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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").
排除标准
- •Do not read or speak English
- •Self-reported personal history of skin cancer
研究组 & 干预措施
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.
干预措施: Education (Behavioral)
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.
干预措施: Action Plan (Behavioral)
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.
干预措施: UV Photo (Behavioral)
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.
干预措施: MC1R Test (Behavioral)
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.
干预措施: Education (Behavioral)
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.
干预措施: Action Plan (Behavioral)
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.
干预措施: UV Photo (Behavioral)
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.
干预措施: Education (Behavioral)
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.
干预措施: Action Plan (Behavioral)
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.
干预措施: MC1R Test (Behavioral)
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.
干预措施: Education (Behavioral)
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.
干预措施: Action Plan (Behavioral)
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.
干预措施: Education (Behavioral)
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.
干预措施: UV Photo (Behavioral)
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.
干预措施: MC1R Test (Behavioral)
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.
干预措施: Education (Behavioral)
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.
干预措施: UV Photo (Behavioral)
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.
干预措施: Education (Behavioral)
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.
干预措施: MC1R Test (Behavioral)
Education
Students in this intervention will receive education on skin cancer and prevention strategies.
干预措施: Education (Behavioral)
结局指标
主要结局
Change in Sunburn Occurrence
时间窗: Baseline, 1-month post-intervention, 3-months post-intervention, 15-months post-intervention
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?"
次要结局
- Change in Unintentional Tanning Behaviors(Baseline, 1-month post-intervention, 3-months post-intervention, 15-months post-intervention)
- 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 UVR Exposure(Baseline, 1-month post-intervention, 3-months post-intervention, 15-months post-intervention)
研究者
Yelena Wu
Associate Professor, Investigator
University of Utah