An Appearance-Based Intervention to Reduce Teen Skin Cancer Risk (iSTART)

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.

Study Overview

• Status: Completed
• Conditions: Skin Cancer
• Intervention / Treatment: Behavioral: Appearance-Focused Website Intervention; Behavioral: Control Website

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 443
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Johnson City, Tennessee, United States, 37614
      • East Tennessee State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Teenager between 12 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Appearance-Focused Website Intervention; This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model.	Behavioral: Appearance-Focused Website Intervention; The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
Active Comparator: Control Website; Control participants viewed an Internet site designed to provide drug and alcohol education for teens.	Behavioral: Control Website; The control website contains information about alcohol and drug abuse which is oriented for a teen audience.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Indoor Tanning Behavior	Self-report measure of the number of times the teenager has indoor tanned over 12 month time period. The self-report measure has been validated in previous studies.	12 months
Indoor Tanning Intentions	A validated measure of the teenagers intentions to use indoor tanning in the next 12 months. Indoor tanning intentions are measured on a scale that ranges from 1 (definitely do not intend to indoor tan; better) to 7 (definitely do intend to indoor tan; worse).	12 months
Indoor Tanning Willingness	Scale that measures adolescents willingness to indoor tan in the future. Indoor tanning willingness is measured on a scale that ranges from 1 (definitely not willing; better) to 7 (definitely willing; worse).	12 months

Collaborators and Investigators

• Sponsor: East Tennessee State University
• Investigators: Principal Investigator: Joel J Hillhouse, Ph.D., East Tennessee State University

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: January 9, 2012
• First Submitted That Met QC Criteria: January 9, 2012
• First Posted (Estimate): January 11, 2012

Study Record Updates

• Last Update Posted (Estimate): June 2, 2016
• Last Update Submitted That Met QC Criteria: April 26, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Melanoma; Squamous Cell Carcinoma; Basal Cell Carcinoma
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Skin Neoplasms
• Other Study ID Numbers: 1R01CA134891-01A2 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The proposed research will include data from high school teenage women who indoor tan. The final dataset will include self-reported demographic, attitudinal, cognitive and behavioral data from surveys about private personal behaviors. The final dataset will be stripped of identifiers prior to release for sharing. We will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and to not attempting to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.