NCT01508013

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
443

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

June 2, 2016

Completed
Last Updated

June 2, 2016

Status Verified

April 1, 2016

Enrollment Period

3 years

First QC Date

January 9, 2012

Results QC Date

January 21, 2016

Last Update Submit

April 26, 2016

Conditions

Keywords

MelanomaBasal Cell CarcinomaSquamous Cell Carcinoma

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Appearance-Focused Website Intervention

EXPERIMENTAL

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

Behavioral: Appearance-Focused Website Intervention

Control Website

ACTIVE COMPARATOR

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

Behavioral: Control Website

Interventions

The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.

Appearance-Focused Website Intervention
Control WebsiteBEHAVIORAL

The control website contains information about alcohol and drug abuse which is oriented for a teen audience.

Control Website

Eligibility Criteria

Age12 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Tennessee State University

Johnson City, Tennessee, 37614, United States

Location

MeSH Terms

Conditions

Skin NeoplasmsMelanomaCarcinoma, Basal CellCarcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Basal CellNeoplasms, Squamous Cell

Limitations and Caveats

None noted

Results Point of Contact

Title
Dr. Joel Hillhouse
Organization
East Tennessee State University

Study Officials

  • Joel J Hillhouse, Ph.D.

    East Tennessee State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 9, 2012

First Posted

January 11, 2012

Study Start

May 1, 2011

Primary Completion

May 1, 2014

Study Completion

December 1, 2014

Last Updated

June 2, 2016

Results First Posted

June 2, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will share

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.

Locations