Skin Cancer Prevention in a Pediatric Population
2 other identifiers
interventional
867
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2003
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 14, 2011
CompletedFirst Posted
Study publicly available on registry
November 4, 2011
CompletedJanuary 25, 2013
January 1, 2013
3.8 years
August 14, 2011
January 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
sun protection behavior scale
Parent report through telephone interview
change from baseline over 4 years
Secondary Outcomes (1)
Nevus counts
Change from baseline over 4 years
Study Arms (2)
Newsletter intervention
EXPERIMENTALSemi-tailored newsletter intervention for parents and children
Usual care
NO INTERVENTIONNo newsletter intervention
Interventions
Delivered over 3 consecutive years, in the spring
Eligibility Criteria
You may qualify if:
- Child born in 1998, has resided in the Denver, Colorado area
You may not qualify if:
- Parents unable to respond to telephone survey; child has disabling condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- Kaiser Permanentecollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Colorado Denver
Aurora, Colorado, 80045, United States
Related Publications (1)
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.
PMID: 22992358DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2011
First Posted
November 4, 2011
Study Start
November 1, 2003
Primary Completion
September 1, 2007
Study Completion
September 1, 2008
Last Updated
January 25, 2013
Record last verified: 2013-01