Clinical trial NCT01464957: Skin Cancer Prevention in a Pediatric Population
Official title: Skin Cancer Prevention in a Pediatric Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Skin Cancer
Keywords: skin cancer prevention
precaution adoption process model
semi-tailored newsletter
pediatric
behavioral intervention
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Kaiser Permanente
name: National Cancer Institute (NCI)
First posted: 2011-11-04
Enrollment: 867
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: sun protection behavior scale
timeFrame: change from baseline over 4 years
Secondary outcomes:
measure: Nevus counts
timeFrame: Change from baseline over 4 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Lori A Crane, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Joseph Morelli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Permanente
name: Stefan T Morelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.