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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Joel Hillhouse, East Tennessee State University
ClinicalTrials.gov Identifier:
NCT01508013
First received: January 9, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Skin Cancer
Behavioral: Appearance-Focused Website Intervention
Behavioral: Control Website

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: An Appearance-Based Intervention to Reduce Teen Skin Cancer Risk

Resource links provided by NLM:


Further study details as provided by East Tennessee State University:

Primary Outcome Measures:
  • Indoor Tanning Behavior [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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.

  • Indoor tanning intentions [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    A validated measure of the teenagers intentions to use indoor tanning in the next 3, 6 and 12 months.


Secondary Outcome Measures:
  • Indoor tanning attitudes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Validated measure of how positively the teenager feels about indoor tanning

  • Indoor tanning social norms [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 600
Study Start Date: May 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Appearance-Focused Website Intervention 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 Behavioral: Control Website
The control website contains information about alcohol and drug abuse which is oriented for a teen audience.

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.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01508013

Locations
United States, Tennessee
East Tennessee State University
Johnson City, Tennessee, United States, 37614
Sponsors and Collaborators
East Tennessee State University
Investigators
Principal Investigator: Joel J Hillhouse, Ph.D. East Tennessee State University
  More Information

No publications provided

Responsible Party: Joel Hillhouse, Professor, East Tennessee State University
ClinicalTrials.gov Identifier: NCT01508013     History of Changes
Other Study ID Numbers: 1R01CA134891-01A2
Study First Received: January 9, 2012
Last Updated: January 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by East Tennessee State University:
Melanoma
Basal Cell Carcinoma
Squamous Cell Carcinoma

Additional relevant MeSH terms:
Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases

ClinicalTrials.gov processed this record on September 30, 2014