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Completed

NCT Number: NCT01464957

Skin Cancer Prevention in a Pediatric Population

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.

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Key information

Conditions

Skin Cancer Neoplasms Neoplasms by Site Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

5 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Semi-tailored newsletter

Behavioral

Delivered over 3 consecutive years, in the spring

Other names: Semi-tailored newsletter intervention, for parents and children

Primary outcomes

  1. sun protection behavior scale

    Time frame: change from baseline over 4 years

    Parent report through telephone interview

Secondary outcomes

  1. Nevus counts

    Time frame: Change from baseline over 4 years

    Health care provider skin examination of nevi by size and body location

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Kaiser Permanente
  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2003
Primary completion
2007
Study completion
2008
First posted
Nov 4, 2011
Registry last updated
Jan 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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