Skin Health in Young Adults - Preventing Indoor Tanning and Promoting Sun Protection

June 25, 2018 updated by: Yale University
This is a pilot randomized controlled trial of an Internet-based skin cancer prevention intervention as compared to a standard of care control in 80 non-Hispanic white females ages 20-30.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Tanned indoors in past 12 months
  • Able to communicate well in English
  • Reliable Internet access

Exclusion Criteria:

  • History of skin cancer (self-report)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Indoor tanning intervention
Web-based intervention modules to discourage tanning.
Behavioral: Indoor tanning intervention
6 Web-based modules that focus on preventing skin cancer through sun protection and indoor tanning reduction using the Theory of Planned Behavior and Prospect Theory
Active Comparator: standard of care control
General information regarding UV protection measures through an online Qualtrics interface. Content will mirror information provided in brochures typically available in a dermatology office or through skin cancer prevention websites.
Behavioral: Standard of care control
One website with content similar to those available in dermatology offices on skin cancer prevention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intention to indoor tan in next year
Time Frame: Baseline
Indoor tanning intentions are measured on a scale that ranges from 1 (definitely do not intend to indoor tan) to 7 (definitely do intend to indoor tan).
Baseline
Intention to indoor tan in next year
Time Frame: 12 Weeks First Follow-up
Indoor tanning intentions are measured on a scale that ranges from 1 (definitely do not intend to indoor tan) to 7 (definitely do intend to indoor tan).
12 Weeks First Follow-up
Intention to indoor tan in next year
Time Frame: 24 Weeks Second Follow-up
Indoor tanning intentions are measured on a scale that ranges from 1 (definitely do not intend to indoor tan) to 7 (definitely do intend to indoor tan).
24 Weeks Second Follow-up
Number of indoor tanning sessions in the previous 3 months
Time Frame: 12 weeks preceding baseline
Self-report measure of number of times indoor tanned, reported retrospectively for the preceding 3 months.
12 weeks preceding baseline
Number of indoor tanning sessions in the previous 3 months
Time Frame: baseline to 12 Weeks (First Follow-up)
Self-report measure of number of times indoor tanned, reported retrospectively for the preceding 3 months.
baseline to 12 Weeks (First Follow-up)
Number of indoor tanning sessions in the previous 3 months
Time Frame: From 12 Weeks (first Follow-up) to 24 Weeks (Second Follow-up)
Self-report measure of number of times indoor tanned, reported retrospectively for the preceding 3 months.
From 12 Weeks (first Follow-up) to 24 Weeks (Second Follow-up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intention to sunbathe outdoors in the next year
Time Frame: Baseline
Sunbathing intentions are measured on a scale that ranges from 1 (definitely do not intend to indoor tan) to 7 (definitely do intend to indoor tan).
Baseline
Intention to sunbathe outdoors in the next year
Time Frame: 12 weeks First Follow-up
Sunbathing intentions are measured on a scale that ranges from 1 (definitely do not intend to indoor tan) to 7 (definitely do intend to indoor tan).
12 weeks First Follow-up
Intention to sunbathe outdoors in the next year
Time Frame: 24 weeks Second Follow-up
Sunbathing intentions are measured on a scale that ranges from 1 (definitely do not intend to indoor tan) to 7 (definitely do intend to indoor tan).
24 weeks Second Follow-up
Number of outdoor sunbathing sessions in the previous 3 months
Time Frame: 12 weeks preceding baseline
Self-report measure of number of times sunbathed, reported retrospectively for the preceding 3 months.
12 weeks preceding baseline
Number of outdoor sunbathing sessions in the previous 3 months
Time Frame: baseline to 12 Weeks (First Follow-up)
Self-report measure of number of times sunbathed, reported retrospectively for the preceding 3 months.
baseline to 12 Weeks (First Follow-up)
Number of outdoor sunbathing sessions in the previous 3 months
Time Frame: From 12 Weeks (first Follow-up) to 24 Weeks (Second Follow-up)
Self-report measure of number of times sunbathed, reported retrospectively for the preceding 3 months.
From 12 Weeks (first Follow-up) to 24 Weeks (Second Follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

American Cancer Society, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2017

Primary Completion (Actual)

February 27, 2018

Study Completion (Actual)

February 27, 2018

Study Registration Dates

First Submitted

March 20, 2017

First Submitted That Met QC Criteria

April 24, 2017

First Posted (Actual)

April 27, 2017

Study Record Updates

Last Update Posted (Actual)

June 26, 2018

Last Update Submitted That Met QC Criteria

June 25, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1208010685

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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