Skin Cancer Prevention in a Pediatric Population

January 23, 2013 updated by: University of Colorado, Denver
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

867

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 6 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Newsletter intervention
Semi-tailored newsletter intervention for parents and children
Behavioral: Semi-tailored newsletter
Delivered over 3 consecutive years, in the spring
Other Names:
  • Semi-tailored newsletter intervention
  • for parents and children
No Intervention: Usual care
No newsletter intervention

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Cancer Institute (NCI)
Kaiser Permanente

Investigators

  • Principal Investigator: Lori A Crane, PhD, MPH, University of Colorado, Denver
  • Principal Investigator: Joseph Morelli, MD, University of Colorado, Denver
  • Principal Investigator: Stefan T Morelli, MD, Kaiser Permanente

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

August 14, 2011

First Submitted That Met QC Criteria

November 1, 2011

First Posted (Estimate)

November 4, 2011

Study Record Updates

Last Update Posted (Estimate)

January 25, 2013

Last Update Submitted That Met QC Criteria

January 23, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 96-0014
  • R01CA074592 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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