Skin Cancer Prevention in a Pediatric Population

This study has been completed.
Sponsor:
Collaborators:
Kaiser Permanente
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01464957
First received: August 14, 2011
Last updated: January 23, 2013
Last verified: January 2013

August 14, 2011
January 23, 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 ] [ Designated as safety issue: No ]
Parent report through telephone interview
Same as current
Complete list of historical versions of study NCT01464957 on ClinicalTrials.gov Archive Site
Nevus counts [ Time Frame: Change from baseline over 4 years ] [ Designated as safety issue: No ]
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
867
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
Both
5 Years to 6 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01464957
96-0014, R01CA074592
No
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