Skip to main content
Clinical Trials/NCT01464957
NCT01464957
Completed
Phase 2

Skin Cancer Prevention in a Pediatric Population

University of Colorado, Denver1 site in 1 country867 target enrollmentNovember 2003
ConditionsSkin Cancer

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Skin Cancer
Sponsor
University of Colorado, Denver
Enrollment
867
Locations
1
Primary Endpoint
sun protection behavior scale
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2003
End Date
September 2008
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

sun protection behavior scale

Time Frame: change from baseline over 4 years

Parent report through telephone interview

Secondary Outcomes

  • Nevus counts(Change from baseline over 4 years)

Study Sites (1)

Loading locations...

Similar Trials