Skin Cancer Prevention in a Pediatric Population

Study Overview
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Brief Summary
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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
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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.

Official Title
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Skin Cancer Prevention in a Pediatric Population

Conditions
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Skin Cancer

Intervention / Treatment
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* Behavioral: Semi-tailored newsletter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child born in 1998, has resided in the Denver, Colorado area Exclusion Criteria: Parents unable to respond to telephone survey; child has disabling condition

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Newsletter intervention<br>Semi-tailored newsletter intervention for parents and children | Behavioral: Semi-tailored newsletter<br>* Delivered over 3 consecutive years, in the spring<br>* Other names: for parents and children;|
| No Intervention: Usual care<br>No newsletter intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sun protection behavior scale | Parent report through telephone interview | change from baseline over 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nevus counts | Health care provider skin examination of nevi by size and body location | Change from baseline over 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skin cancer prevention, precaution adoption process model, semi-tailored newsletter, pediatric, behavioral intervention