Contemporary clinical trials · 2024
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.
Протокол клинического исследованияСтатьяПоддержка NIH: внешняя программаНазвание и аннотация: Перевод в очереди
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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
Аннотация
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.
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.