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Skin Cancer Prevention in a Pediatric Population

Skin Cancer Prevention in a Pediatric Population

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01464957
Enrollment
867
Registered
2011-11-04
Start date
2003-11-30
Completion date
2008-09-30
Last updated
2013-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Cancer

Keywords

skin cancer prevention, precaution adoption process model, semi-tailored newsletter, pediatric, behavioral intervention

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.

Interventions

BEHAVIORALSemi-tailored newsletter

Delivered over 3 consecutive years, in the spring

Sponsors

Kaiser Permanente
CollaboratorOTHER
National Cancer Institute (NCI)
CollaboratorNIH
University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to 6 Years
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

Design outcomes

Primary

MeasureTime frameDescription
sun protection behavior scalechange from baseline over 4 yearsParent report through telephone interview

Secondary

MeasureTime frameDescription
Nevus countsChange from baseline over 4 yearsHealth care provider skin examination of nevi by size and body location

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026