An Appearance-Based Intervention to Reduce Teen Skin Cancer Risk

Skin Cancer Clinical Trial

— iSTART  

Official title:

An Appearance-Based Intervention to Reduce Teen Skin Cancer Risk

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01508013
• Other study ID #: 1R01CA134891-01A2
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 9, 2012
• Last updated: January 9, 2012
• Start date: May 2011
• Est. completion date: December 2014

Study information

• Verified date: January 2012
• Source: East Tennessee State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a skin cancer prevention website is effective at reduce female teenagers' desire to use indoor tanning and ultimately their use of indoor tanning over an 18 month period.

Description:

The project is designed to improve the understanding of, and ability to affect UV risk behavior in teenage populations. The International Agency for Research in Cancer classifies indoor tanning as "carcinogenic to humans." There is evidence that female indoor tanning use increases dramatically from freshman to senior years of high school (e.g., 25-40% of older high school girls) making high school a critical time period for anti-tanning interventions to be carried out. This proposal assesses the effectiveness of a skin cancer prevention website for a nationally representative sample of high school teens in a randomized controlled trial. Teens exposed to the website will report reduced indoor tanning intentions, frequency and overall percentage of users while increasing sun protective behaviors at long-term (i.e 18 month) follow-up.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 600
• Est. completion date: December 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 18 Years

Eligibility

Inclusion Criteria:

• Teenager between 13 and 18 years old; has either indoor tanned in the past year or has indicated their intentions to indoor tan in the coming year.

Exclusion Criteria:

• None other than not meeting inclusion criteria.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Skin Cancer
• Skin Neoplasms

Intervention

Behavioral:
• Appearance-Focused Website Intervention
The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
• Control Website
The control website contains information about alcohol and drug abuse which is oriented for a teen audience.

Locations

Country	Name	City	State
United States	East Tennessee State University	Johnson City	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
East Tennessee State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Indoor Tanning Behavior	Self-report measure of the number of times the teenager has indoor tanned over 3, 6, 12 and 18 month time periods. The self-report measure has been validated in previous studies.	18 months	No
Primary	Indoor tanning intentions	A validated measure of the teenagers intentions to use indoor tanning in the next 3, 6 and 12 months.	18 months	No
Secondary	Indoor tanning attitudes	Validated measure of how positively the teenager feels about indoor tanning	1 year	No
Secondary	Indoor tanning social norms	Validated measure of how positively the teenager's friends and family feel about indoor tanning and how often their peers and family indoor tans themselves.	1 year	No