Skin Cancer Prevention in a Pediatric Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01464957
Recruitment Status : Completed
First Posted : November 4, 2011
Last Update Posted : January 25, 2013
Kaiser Permanente
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Colorado, Denver

August 14, 2011
November 4, 2011
January 25, 2013
November 2003
September 2007   (Final data collection date for primary outcome measure)
sun protection behavior scale [ Time Frame: change from baseline over 4 years ]
Parent report through telephone interview
Same as current
Complete list of historical versions of study NCT01464957 on Archive Site
Nevus counts [ Time Frame: Change from baseline over 4 years ]
Health care provider skin examination of nevi by size and body location
Same as current
Not Provided
Not Provided
Skin Cancer Prevention in a Pediatric Population
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.
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.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Skin Cancer
Behavioral: Semi-tailored newsletter
Delivered over 3 consecutive years, in the spring
Other Names:
  • Semi-tailored newsletter intervention
  • for parents and children
  • Experimental: Newsletter intervention
    Semi-tailored newsletter intervention for parents and children
    Intervention: Behavioral: Semi-tailored newsletter
  • No Intervention: Usual care
    No newsletter intervention
Crane LA, Asdigian NL, Barón AE, Aalborg J, Marcus AC, Mokrohisky ST, Byers TE, Dellavalle RP, Morelli JG. Mailed intervention to promote sun protection of children: a randomized controlled trial. Am J Prev Med. 2012 Oct;43(4):399-410.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 2008
September 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
5 Years to 6 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
R01CA074592 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
University of Colorado, Denver
University of Colorado, Denver
  • Kaiser Permanente
  • National Cancer Institute (NCI)
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
University of Colorado, Denver
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP