An Appearance-Based Intervention to Reduce Teen Skin Cancer Risk - Full Text View

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:

MedlinePlus related topics: Skin Cancer

U.S. FDA Resources

Further study details as provided by East Tennessee State University:

Primary Outcome Measures:

Indoor Tanning Behavior [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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).


Enrollment:	443
Study Start Date:	May 2011
Study Completion Date:	December 2014
Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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:	12 Years to 18 Years (Child, Adult)
Genders 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

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


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
Results First Received:	January 21, 2016
Last Updated:	April 26, 2016
Health Authority:	United States: Institutional Review Board
Individual Participant Data
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 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 29, 2016

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