Clinical Trials Directory

Trials / Completed

CompletedNCT01464957

Skin Cancer Prevention in a Pediatric Population

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
867 (actual)
Sponsor
University of Colorado, Denver · Academic / Other
Sex
All
Age
5 Years – 6 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSemi-tailored newsletterDelivered over 3 consecutive years, in the spring

Timeline

Start date
2003-11-01
Primary completion
2007-09-01
Completion
2008-09-01
First posted
2011-11-04
Last updated
2013-01-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01464957. Inclusion in this directory is not an endorsement.