Trials / Completed
CompletedNCT01464957
Skin Cancer Prevention in a Pediatric Population
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 867 (actual)
- Sponsor
- University of Colorado, Denver · Academic / Other
- Sex
- All
- Age
- 5 Years – 6 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Semi-tailored newsletter | Delivered over 3 consecutive years, in the spring |
Timeline
- Start date
- 2003-11-01
- Primary completion
- 2007-09-01
- Completion
- 2008-09-01
- First posted
- 2011-11-04
- Last updated
- 2013-01-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01464957. Inclusion in this directory is not an endorsement.