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临床试验/NCT03607578
NCT03607578已完成不适用

Test of Developed Interventions to Prevent Skin Cancer: a Randomized Study Targeting Danes Going on Vacation to Sunny Destinations With High UV Index

Brian Køster2 个研究点 分布在 1 个国家目标入组 1,548 人开始时间: 2018年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,548
试验地点
2
主要终点
Sunburn

研究概览

简要总结

The aim of the study is to test a series of developed effective interventions targeting Danes going on vacation to sunny destinations to decrease sunburn by increasing use of shade, hats, protective clothing, and sunscreen to prevent skin cancer in the Danish population. It has been estimated that up to 90 % of all skin cancers could be avoided by behavioral changes. One of the main sources of UVR exposure in the Danish population is vacations to destinations with high UV index (UVI).

详细描述

The aim of the study is to test a series of developed effective interventions targeting Danes going on vacation to sunny destinations to decrease sunburn by increasing use of shade, hats, protective clothing, and sunscreen to prevent skin cancer in the Danish population. To achieve the aim of this study we will conduct a randomized controlled trial with four arms during May-Dec 2018. Participants will be Danish adults traveling on vacation in 2018 for a period of 1-3 weeks, recruited from the civil registration system. After enrollment and pretesting, participants will be randomly assigned to one of four experimental conditions. Three experimental groups will receive innovative intervention strategies for promoting sun protection practices during vacation - Protection Routine (1), Protection Routine (2) or both Protection Routine (1+2). The fourth experimental condition will be a minimal treatment control group. The primary outcomes of the trial will be a reduction in frequency of sunburn by adherence to the current sun protection advice from the Danish Cancer Society, i.e., use of shade, hats, protective clothing, and sunscreen as secondary outcomes. We hypothesize that the following two interventions will be able to reduce significantly the UVR exposure and risk of sunburns in Danes going on vacation to destinations with high UVI.

The participants of the study are recruited from the Danish civil registration based system. The study population will represent all groups of the Danish population. Eligibility criteria for the project are persons living in Denmark going on vacation in May-December 2018 and having a smartphone compatible with either apple iOS (version 7.0 or newer) or Google Android (version 4.0 or newer). The period May to December is chosen as it includes all types of vacationers. The summer vacation constitutes the majority of the sunny vacations of the Danes. The period includes both the summer, where Danes typically travel to the Mediterranean area and the winter period where travel patterns change a bit to more exotic areas like Thailand, Egypt and the Canarias Islands. Exclusion criteria are persons younger than 18 years of age.

Sun protective behavior, exposure to UVR and sunburn will be evaluated by use of a questionnaire validated by personal electronic UV-measurements. This newly developed survey tool has made it possible in this project to evaluate the skin cancer interventions, without tracking of development of skin cancer which can take several years to develop after excessive UVR exposure. The short time period from intervention to evaluation minimizes recall bias.

The primary success criteria of the effectiveness of the interventions is a 10 % decrease in sunburn fraction in the intervention groups as compared to the control group in the post-intervention measurement, as shown possible in the pilot study.

Furthermore, we aim to reach completion and response rates of 90 % of the total sample

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Travel for a vacation to a location with higher UVI than Denmark in the trial period (May-December 2018)
  • Access to a smartphone compatible with either iOS (version 7 or newer) or Google Android ( version 4.0 or newer)

排除标准

  • Physically or mentally uncapable to complete the planned intervention routines

研究组 & 干预措施

Control Group - Minimal Intervention

Other

Minimal intervention

干预措施: Other: Control Group - Minimal Intervention (Behavioral)

Protection Routine 2

Experimental

干预措施: Experimental: Protection Routine 2 (Behavioral)

Protection Routine 1+2

Experimental

干预措施: Experimental: Protection Routine 1 (Behavioral)

Protection Routine 1+2

Experimental

干预措施: Experimental: Protection Routine 2 (Behavioral)

Protection Routine 1

Experimental

干预措施: Experimental: Protection Routine 1 (Behavioral)

结局指标

主要结局

Sunburn

时间窗: Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)

Any erythema (selfdetermined by questionnaire which is sent within a week after travelling home)

次要结局

  • Use of sunprotection;hat(Experienced during participants vacationperiod (1-3 weeks within may-dec 2018))
  • Awareness of skin cancer risk(Experienced during participants vacationperiod (1-3 weeks within may-dec 2018))
  • Use of sunprotection;shade(Experienced during participants vacationperiod (1-3 weeks within may-dec 2018))
  • Use of sunprotection;clothes(Experienced during participants vacationperiod (1-3 weeks within may-dec 2018))
  • Use of sunprotection;sunscreen(Experienced during participants vacationperiod (1-3 weeks within may-dec 2018))
  • Sunburn body site(Experienced during participants vacationperiod (1-3 weeks within may-dec 2018))
  • Exposure in UV peak hours(Experienced during participants vacationperiod (1-3 weeks within may-dec 2018))

研究者

发起方
Brian Køster
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Brian Køster

Research scientist

Danish Cancer Society

研究点 (2)

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