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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 22, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 27, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 27, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Skin Neoplasms

Clinical Trials on Indoor tanning intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings