Skin Cancer Prevention in a Pediatric Population

Phase 2

Completed

• Conditions: Skin Cancer
• Interventions: Behavioral: Semi-tailored newsletter

• Registration Number: NCT01464957
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2003-11
• Primary Completion: 2007-09
• Study Completion: 2008-09
• Study First Submitted: 2011-08-14
• Study First Submitted QC: 2011-11-01
• Study First Posted: 2011-11-04
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-23
• Last Update Posted: 2013-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 867

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Newsletter intervention	Semi-tailored newsletter	Semi-tailored newsletter intervention for parents and children

Primary Outcome Measures

Name	Time	Method
sun protection behavior scale	change from baseline over 4 years	Parent report through telephone interview

Secondary Outcome Measures

Name	Time	Method
Nevus counts	Change from baseline over 4 years	Health care provider skin examination of nevi by size and body location

Trial Locations

Locations (1)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States