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

Primary Purpose

Skin Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Indoor tanning intervention
Standard of care control
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Skin Neoplasms

Eligibility Criteria

20 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Yale School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Indoor tanning intervention

standard of care control

Arm Description

Web-based intervention modules to discourage tanning.

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.

Outcomes

Primary Outcome Measures

Intention to indoor tan in next year
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).
Intention to indoor tan in next year
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).
Intention to indoor tan in next year
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).
Number of indoor tanning sessions in the previous 3 months
Self-report measure of number of times indoor tanned, reported retrospectively for the preceding 3 months.
Number of indoor tanning sessions in the previous 3 months
Self-report measure of number of times indoor tanned, reported retrospectively for the preceding 3 months.
Number of indoor tanning sessions in the previous 3 months
Self-report measure of number of times indoor tanned, reported retrospectively for the preceding 3 months.

Secondary Outcome Measures

Intention to sunbathe outdoors in the next year
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).
Intention to sunbathe outdoors in the next year
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).
Intention to sunbathe outdoors in the next year
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).
Number of outdoor sunbathing sessions in the previous 3 months
Self-report measure of number of times sunbathed, reported retrospectively for the preceding 3 months.
Number of outdoor sunbathing sessions in the previous 3 months
Self-report measure of number of times sunbathed, reported retrospectively for the preceding 3 months.
Number of outdoor sunbathing sessions in the previous 3 months
Self-report measure of number of times sunbathed, reported retrospectively for the preceding 3 months.

Full Information

First Posted
March 20, 2017
Last Updated
June 25, 2018
Sponsor
Yale University
Collaborators
American Cancer Society, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03132012
Brief Title
Skin Health in Young Adults - Preventing Indoor Tanning and Promoting Sun Protection
Official Title
Skin Health in Young Adults - Preventing Indoor Tanning and Promoting Sun Protection
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 22, 2017 (Actual)
Primary Completion Date
February 27, 2018 (Actual)
Study Completion Date
February 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
American Cancer Society, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Neoplasms

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indoor tanning intervention
Arm Type
Experimental
Arm Description
Web-based intervention modules to discourage tanning.
Arm Title
standard of care control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Indoor tanning intervention
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Standard of care control
Intervention Description
One website with content similar to those available in dermatology offices on skin cancer prevention
Primary Outcome Measure Information:
Title
Intention to indoor tan in next year
Description
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).
Time Frame
Baseline
Title
Intention to indoor tan in next year
Description
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).
Time Frame
12 Weeks First Follow-up
Title
Intention to indoor tan in next year
Description
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).
Time Frame
24 Weeks Second Follow-up
Title
Number of indoor tanning sessions in the previous 3 months
Description
Self-report measure of number of times indoor tanned, reported retrospectively for the preceding 3 months.
Time Frame
12 weeks preceding baseline
Title
Number of indoor tanning sessions in the previous 3 months
Description
Self-report measure of number of times indoor tanned, reported retrospectively for the preceding 3 months.
Time Frame
baseline to 12 Weeks (First Follow-up)
Title
Number of indoor tanning sessions in the previous 3 months
Description
Self-report measure of number of times indoor tanned, reported retrospectively for the preceding 3 months.
Time Frame
From 12 Weeks (first Follow-up) to 24 Weeks (Second Follow-up)
Secondary Outcome Measure Information:
Title
Intention to sunbathe outdoors in the next year
Description
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).
Time Frame
Baseline
Title
Intention to sunbathe outdoors in the next year
Description
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).
Time Frame
12 weeks First Follow-up
Title
Intention to sunbathe outdoors in the next year
Description
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).
Time Frame
24 weeks Second Follow-up
Title
Number of outdoor sunbathing sessions in the previous 3 months
Description
Self-report measure of number of times sunbathed, reported retrospectively for the preceding 3 months.
Time Frame
12 weeks preceding baseline
Title
Number of outdoor sunbathing sessions in the previous 3 months
Description
Self-report measure of number of times sunbathed, reported retrospectively for the preceding 3 months.
Time Frame
baseline to 12 Weeks (First Follow-up)
Title
Number of outdoor sunbathing sessions in the previous 3 months
Description
Self-report measure of number of times sunbathed, reported retrospectively for the preceding 3 months.
Time Frame
From 12 Weeks (first Follow-up) to 24 Weeks (Second Follow-up)

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Yale School of Public Health
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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