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Trial record 8 of 378 for:    "Skin Neoplasms"

Skin Cancer Prevention in a Pediatric Population

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01464957
First Posted: November 4, 2011
Last Update Posted: January 25, 2013
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.
Collaborators:
Kaiser Permanente
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Colorado, Denver
  Purpose
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 (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.
  Eligibility

Information from the National Library of Medicine

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

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
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 ClinicalTrials.gov identifier (NCT number): NCT01464957


Locations
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)
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01464957     History of Changes
Other Study ID Numbers: 96-0014
R01CA074592 ( U.S. NIH Grant/Contract )
First Submitted: August 14, 2011
First Posted: November 4, 2011
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
pediatric
behavioral intervention

Additional relevant MeSH terms:
Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases