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

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ClinicalTrials.gov Identifier: NCT01508013
Recruitment Status : Completed
First Posted : January 11, 2012
Results First Posted : June 2, 2016
Last Update Posted : June 2, 2016
Sponsor:
Information provided by (Responsible Party):
Joel Hillhouse, East Tennessee State University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Skin Cancer Behavioral: Appearance-Focused Website Intervention Behavioral: Control Website Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 443 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: An Appearance-Based Intervention to Reduce Teen Skin Cancer Risk
Study Start Date : May 2011
Actual Primary Completion Date : May 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer Tanning
U.S. FDA Resources

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Indoor Tanning Behavior [ Time Frame: 12 months ]
    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.

  2. Indoor Tanning Intentions [ Time Frame: 12 months ]
    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).

  3. Indoor Tanning Willingness [ Time Frame: 12 months ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Joel Hillhouse, Professor, East Tennessee State University
ClinicalTrials.gov Identifier: NCT01508013     History of Changes
Other Study ID Numbers: 1R01CA134891-01A2 ( U.S. NIH Grant/Contract )
First Posted: January 11, 2012    Key Record Dates
Results First Posted: June 2, 2016
Last Update Posted: June 2, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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

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