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大学生皮肤癌预防风险信息与教育(RISE-UP)研究:一项针对大学生预防皮肤癌的个性化防晒干预试验方案

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.

作者信息

Wu Yelena P, Woodside Liberty A, Kaphingst Kimberly A, Jensen Jakob D, Hamilton Jada G, Kohlmann Wendy, Haaland Ben, Brintz Ben J, Phillips Siobhan M, Hay Jennifer L

机构信息

Department of Dermatology, University of Utah, 30 North 1900 East, 4A330, Salt Lake City, UT 84132, USA; Huntsman Cancer Institute, University of Utah, 2000 Circle of Hope Drive, Salt Lake City, UT 84112, USA.

Huntsman Cancer Institute, University of Utah, 2000 Circle of Hope Drive, Salt Lake City, UT 84112, USA.

出版信息

Contemp Clin Trials. 2024 Dec;147:107728. doi: 10.1016/j.cct.2024.107728. Epub 2024 Nov 2.

Abstract

BACKGROUND

Addressing the increasing incidence of skin cancer among young adults is a priority. The objective of the Risk Information and Skin-cancer Education for Undergraduate Prevention (RISE-UP) study is to identify personalized intervention components to prevent sunburn, a clinically significant outcome highly associated with skin cancer, in college students.

METHODS

Guided by the Elaboration Likelihood Model, the study will use Multiphase Optimization Strategy (MOST) methodology to test three intervention components (ultraviolet photography, MC1R genetic testing, and action planning) each with two levels (yes v. no) in a full-factorial experiment to evaluate unique and combined effects of these components to improve outcomes over the longer-term, with seasonally timed follow-up. At-risk University of Utah students (N = 528) will be recruited. Eligibility criteria include self-reported sunburn or tanning in the past year, or not utilizing recommended sun protection. After baseline assessment, participants will be randomized to intervention group, stratified by sex. Assessments will be completed at (1) Baseline; (2) Intervention; (3) 1 month after intervention; (4) 4 months after intervention (the end of the first summer); and (5) 15 months after intervention (the end of the second summer). The primary outcome will be participants' self-reported number of sunburns. Secondary outcomes will include self-reported sun protection and tanning behaviors and, in a randomly selected subgroup, an objective measure of ultraviolet radiation (UVR) exposure.

CONCLUSION

The RISE-UP study will determine the efficacy of different combinations of personalized skin cancer preventative interventions for young adults and determine the optimal combination of intervention components to prevent skin cancer.

CLINICAL TRIAL REGISTRATION

NCT05634252.

摘要

背景

应对年轻成年人皮肤癌发病率不断上升的问题是当务之急。本科预防风险信息与皮肤癌教育(RISE-UP)研究的目的是确定个性化干预措施,以预防大学生晒伤,晒伤是一种与皮肤癌高度相关的具有临床意义的结果。

方法

在精细可能性模型的指导下,该研究将使用多阶段优化策略(MOST)方法,在全因子实验中测试三个干预措施(紫外线摄影、MC1R基因检测和行动计划),每个措施有两个水平(是与否),以评估这些措施的独特效果和组合效果,从而在长期内改善结果,并进行季节性定时随访。将招募犹他大学的高危学生(N = 528)。入选标准包括在过去一年中自我报告有晒伤或晒黑情况,或未采取推荐的防晒措施。在基线评估后,参与者将按性别分层随机分为干预组。评估将在以下时间点完成:(1)基线;(2)干预时;(3)干预后1个月;(4)干预后4个月(第一个夏天结束时);(5)干预后15个月(第二个夏天结束时)。主要结果将是参与者自我报告的晒伤次数。次要结果将包括自我报告的防晒和晒黑行为,以及在一个随机选择的亚组中,对紫外线辐射(UVR)暴露的客观测量。

结论

RISE-UP研究将确定针对年轻成年人的个性化皮肤癌预防干预措施的不同组合的疗效,并确定预防皮肤癌的干预措施的最佳组合。

临床试验注册

NCT05634252。

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