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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

Brief Summary:
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 or disease Intervention/treatment Phase
Skin Cancer Behavioral: Semi-tailored newsletter Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 867 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Skin Cancer Prevention in a Pediatric Population
Study Start Date : November 2003
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer

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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01464957

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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)
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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 automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Colorado, Denver Identifier: NCT01464957    
Other Study ID Numbers: 96-0014
R01CA074592 ( U.S. NIH Grant/Contract )
First Posted: November 4, 2011    Key Record Dates
Last Update Posted: January 25, 2013
Last Verified: January 2013
Keywords provided by University of Colorado, Denver:
skin cancer prevention
precaution adoption process model
semi-tailored newsletter
behavioral intervention
Additional relevant MeSH terms:
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Skin Neoplasms
Neoplasms by Site
Skin Diseases