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临床试验/NCT01464957
NCT01464957已完成2 期

Skin Cancer Prevention in a Pediatric Population

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 867 人开始时间: 2003年11月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
867
试验地点
2
主要终点
sun protection behavior scale

研究概览

简要总结

Skin cancer risk is largely determined by sun exposure during childhood. This study determines the effectiveness of a mailed intervention designed to increase sun protection for children age 6-9 years old. The intervention includes newsletters for parents that include risk information tailored to each child. Also included are sun protection resources such as a swim shirt, a sun hat, and sunscreen. Participants receive the intervention over 3 consecutive years, and data collection includes telephone interviews and skin exams. The study hypothesis is that receipt of the intervention will result in improved sun protection of the child.

详细描述

About 1 in 90 American children born in the late 1990's will develop malignant melanoma in their lifetimes. Sun exposure in childhood appears to be the most important preventable risk factor for this disease. This project will develop a tailored, risk-based, written intervention, which will be mailed to parents of children age 6-9 years in the spring of each year. The tailored intervention will utilize the Precaution Adoption Process Model, which has a primary focus on risk perception and suggests that there are seven stages leading to sustained health behavior change. The effectiveness of the intervention will be tested using a randomized controlled trail involving 1000 children recruited from health care facilities and community locations at age 5-6 years and followed for 3 years using telephone interviews to assess sun protection behaviors and skin exams to observe changes in melanocytic nevi, freckling, and tanning.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
5 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child born in 1998, has resided in the Denver, Colorado area

排除标准

  • Parents unable to respond to telephone survey; child has disabling condition

结局指标

主要结局

sun protection behavior scale

时间窗: change from baseline over 4 years

Parent report through telephone interview

次要结局

  • Nevus counts(Change from baseline over 4 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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