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Trial record 8 of 351 for:    "Skin Neoplasms"

Skin Cancer Prevention in a Pediatric Population

This study has been completed.
Kaiser Permanente
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Colorado, Denver Identifier:
First received: August 14, 2011
Last updated: January 23, 2013
Last verified: January 2013
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.

Condition Intervention Phase
Skin Cancer
Behavioral: Semi-tailored newsletter
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Skin Cancer Prevention in a Pediatric Population

Resource links provided by NLM:

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • sun protection behavior scale [ Time Frame: change from baseline over 4 years ]
    Parent report through telephone interview

Secondary Outcome Measures:
  • Nevus counts [ Time Frame: Change from baseline over 4 years ]
    Health care provider skin examination of nevi by size and body location

Enrollment: 867
Study Start Date: November 2003
Study Completion Date: September 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   5 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01464957

United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
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
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Colorado, Denver Identifier: NCT01464957     History of Changes
Other Study ID Numbers: 96-0014
R01CA074592 ( US NIH Grant/Contract Award Number )
Study First Received: August 14, 2011
Last Updated: January 23, 2013

Keywords provided by University of Colorado, Denver:
skin cancer prevention
precaution adoption process model
semi-tailored newsletter
behavioral intervention

Additional relevant MeSH terms:
Skin Neoplasms
Neoplasms by Site
Skin Diseases processed this record on May 23, 2017