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

Primary Purpose

Skin Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Appearance-Focused Website Intervention
Control Website
Sponsored by
East Tennessee State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Skin Cancer focused on measuring Melanoma, Basal Cell Carcinoma, Squamous Cell Carcinoma

Eligibility Criteria

12 Years - 18 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • East Tennessee State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Appearance-Focused Website Intervention

Control Website

Arm Description

This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model.

Control participants viewed an Internet site designed to provide drug and alcohol education for teens.

Outcomes

Primary Outcome Measures

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.
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).
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).

Secondary Outcome Measures

Full Information

First Posted
January 9, 2012
Last Updated
April 26, 2016
Sponsor
East Tennessee State University
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1. Study Identification

Unique Protocol Identification Number
NCT01508013
Brief Title
An Appearance-Based Intervention to Reduce Teen Skin Cancer Risk
Acronym
iSTART
Official Title
An Appearance-Based Intervention to Reduce Teen Skin Cancer Risk
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
East Tennessee State University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Cancer
Keywords
Melanoma, Basal Cell Carcinoma, Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
443 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Appearance-Focused Website Intervention
Arm Type
Experimental
Arm Description
This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model.
Arm Title
Control Website
Arm Type
Active Comparator
Arm Description
Control participants viewed an Internet site designed to provide drug and alcohol education for teens.
Intervention Type
Behavioral
Intervention Name(s)
Appearance-Focused Website Intervention
Intervention Description
The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
Intervention Type
Behavioral
Intervention Name(s)
Control Website
Intervention Description
The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
Primary Outcome Measure Information:
Title
Indoor Tanning Behavior
Description
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.
Time Frame
12 months
Title
Indoor Tanning Intentions
Description
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).
Time Frame
12 months
Title
Indoor Tanning Willingness
Description
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).
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel J Hillhouse, Ph.D.
Organizational Affiliation
East Tennessee State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
East Tennessee State University
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37614
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

An Appearance-Based Intervention to Reduce Teen Skin Cancer Risk

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