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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01464957
Other study ID # 96-0014
Secondary ID R01CA074592
Status Completed
Phase Phase 2
First received August 14, 2011
Last updated January 23, 2013
Start date November 2003
Est. completion date September 2008

Study information

Verified date January 2013
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 867
Est. completion date September 2008
Est. primary completion date September 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 5 Years to 6 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Semi-tailored newsletter
Delivered over 3 consecutive years, in the spring

Locations

Country Name City State
United States University of Colorado Denver Aurora Colorado

Sponsors (3)

Lead Sponsor Collaborator
University of Colorado, Denver Kaiser Permanente, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary sun protection behavior scale Parent report through telephone interview change from baseline over 4 years No
Secondary Nevus counts Health care provider skin examination of nevi by size and body location Change from baseline over 4 years No
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