Skin Cancer Prevention in a Pediatric Population
Primary Purpose
Skin Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Semi-tailored newsletter
Sponsored by
About this trial
This is an interventional prevention trial for Skin Cancer focused on measuring skin cancer prevention, precaution adoption process model, semi-tailored newsletter, pediatric, behavioral intervention
Eligibility 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
Sites / Locations
- University of Colorado Denver
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Newsletter intervention
Usual care
Arm Description
Semi-tailored newsletter intervention for parents and children
No newsletter intervention
Outcomes
Primary Outcome Measures
sun protection behavior scale
Parent report through telephone interview
Secondary Outcome Measures
Nevus counts
Health care provider skin examination of nevi by size and body location
Full Information
NCT ID
NCT01464957
First Posted
August 14, 2011
Last Updated
January 23, 2013
Sponsor
University of Colorado, Denver
Collaborators
Kaiser Permanente, National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT01464957
Brief Title
Skin Cancer Prevention in a Pediatric Population
Official Title
Skin Cancer Prevention in a Pediatric Population
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Kaiser Permanente, National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Cancer
Keywords
skin cancer prevention, precaution adoption process model, semi-tailored newsletter, pediatric, behavioral intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
867 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Newsletter intervention
Arm Type
Experimental
Arm Description
Semi-tailored newsletter intervention for parents and children
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
No newsletter intervention
Intervention Type
Behavioral
Intervention Name(s)
Semi-tailored newsletter
Other Intervention Name(s)
Semi-tailored newsletter intervention, for parents and children
Intervention Description
Delivered over 3 consecutive years, in the spring
Primary Outcome Measure Information:
Title
sun protection behavior scale
Description
Parent report through telephone interview
Time Frame
change from baseline over 4 years
Secondary Outcome Measure Information:
Title
Nevus counts
Description
Health care provider skin examination of nevi by size and body location
Time Frame
Change from baseline over 4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori A Crane, PhD, MPH
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph Morelli, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stefan T Morelli, MD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22992358
Citation
Crane LA, Asdigian NL, Baron 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. doi: 10.1016/j.amepre.2012.06.022.
Results Reference
derived
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Skin Cancer Prevention in a Pediatric Population
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