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

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2024-11-02 DOI:10.1016/j.cct.2024.107728

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

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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

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本科生预防皮肤癌的风险信息和皮肤癌教育（RISE-UP）研究：大学生预防皮肤癌的个性化防晒干预试验方案。

背景：解决年轻人皮肤癌发病率不断上升的问题是当务之急。大学生预防皮肤癌的风险信息和皮肤癌教育（RISE-UP）研究的目的是确定个性化的干预措施，以预防大学生晒伤，晒伤是与皮肤癌高度相关的临床重要结果：该研究将以阐释可能性模型（Elaboration Likelihood Model）为指导，采用多阶段优化策略（Multiphase Optimization Strategy，MOST）方法，在全因子实验中测试三种干预措施（紫外线照相、MC1R 基因检测和行动规划），每种措施有两个水平（是与否），以评估这些措施的独特效果和综合效果，从而在较长时期内改善结果，并按季节时间进行随访。将招募犹他大学的高危学生（N = 528）。资格标准包括自我报告在过去一年中被晒伤或晒黑，或未使用建议的防晒措施。基线评估结束后，参与者将按性别随机分配到干预组。评估将在（1）基线；（2）干预；（3）干预后 1 个月；（4）干预后 4 个月（第一个夏季结束时）；以及（5）干预后 15 个月（第二个夏季结束时）完成。主要结果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，以及在随机抽取的分组中，对紫外线辐射（UVR）暴露的客观测量：RISE-UP研究将确定针对年轻人的不同个性化皮肤癌预防干预措施组合的疗效，并确定预防皮肤癌的最佳干预措施组合：临床试验注册：NCT05634252。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.