A Tailored Internet Intervention to Reduce Skin Cancer Risk Behaviors Among Young Adults (UV4me)

June 29, 2018 updated by: Carolyn Heckman, Fox Chase Cancer Center

Skin cancer is the most common cancer in the US, with over a million new cases diagnosed yearly. Young adults are increasingly at risk of melanoma. Contributing to the increasing skin cancer risk is the fact that US adolescents have the lowest skin protection rates of all age groups and also demonstrate increased exposure to natural and artificial UV radiation. Innovative interventions are needed to have an impact on skin cancer risk among young people. Unlike previous interventions, our skin cancer risk reduction intervention will be tailored (or personalized) to each individual participant and delivered via the Internet. The intervention will emphasize appearance concerns, which are known to be the primary motivation for UV exposure and lack of skin protection among young adults. This will be accomplished in part through the use of personalized facial images showing UV damage as well as computerized age progression demonstrations.

Primary Aim 1. To examine the efficacy of a tailored intervention delivered via the Internet designed to increase skin protection and decrease sun exposure behavior among young adults at moderate to high risk of developing skin cancer. Participants will be randomized to the tailored intervention, the Skin Cancer Foundation website, or an assessment only condition.

Aim 2. To evaluate whether sociodemographic variables (sex, race/ethnicity, skin type, family history of skin cancer), appearance consciousness, and past exposure and protective behaviors moderate intervention effects.

Aim 3. To evaluate whether Integrative Model constructs (UV-related knowledge, risk perception, beliefs, norms, self-efficacy, and intentions) mediate intervention effects.

The goals of future research would be to enhance the tailored intervention, for example, by adding additional contacts or Internet technologies or features, disseminate the intervention, assess the longevity of effects, and/or adapt the tailored intervention for use with other cancer risk behaviors or at risk groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1234

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
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center

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

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-25 years old
  • Moderate to high risk of skin cancer (cut-off of >=27 on the Brief Skin Cancer Risk Assessment Tool)

Exclusion Criteria:

  • History of skin cancer

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tailored Intervention
Subject has access to the tailored web intervention
Behavioral: UV4me
Tailored website includes: personalized responses to quizzes, information on skin type and burn risk, UV damage photo of similar individual, avatar activity, age progression images, personal risk calculator, SPF (sun protection factor) calculator
Other Names:
  • Tailored Intervention for Skin Cancer Risk Reduction
Active Comparator: Skin Cancer Foundation Website
Subject has access to the pre-existing Skin Cancer Foundation website
Behavioral: Skin Cancer Foundation website
Current best practice website for skin cancer and prevention. Includes information, images, news, and opportunities for advocacy.
No Intervention: Assessment Only Condition
Subjects will only complete assessments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sun protection
Time Frame: Follow-up 1 (3 weeks after baseline)
Continuous measure examining frequency of sun protection behaviors (e.g., sunscreen use, clothing, shade, sunglasses), using items adapted from Glanz and colleagues (2008)
Follow-up 1 (3 weeks after baseline)
Sun protection
Time Frame: Follow-up 2 (12 weeks after baseline)
Continuous measure examining frequency of sun protection behaviors (e.g., sunscreen use, clothing, shade, sunglasses), using items adapted from Glanz and colleagues (2008)
Follow-up 2 (12 weeks after baseline)
Outdoor UV Exposure
Time Frame: Follow-up 1 (3 weeks after baseline)
How many hours participants spend in the sun during peak daylight hours during the week
Follow-up 1 (3 weeks after baseline)
Outdoor UV exposure
Time Frame: Follow-up 2 (12 weeks after baseline)
How many hours participants spend in the sun during peak daylight hours during the week
Follow-up 2 (12 weeks after baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Indoor Tanning
Time Frame: Follow-up 1 (3 weeks after baseline)
Number of indoor tanning sessions in past month
Follow-up 1 (3 weeks after baseline)
Indoor Tanning
Time Frame: Follow-up 2 (12 weeks after baseline)
Number of indoor tanning sessions in past month
Follow-up 2 (12 weeks after baseline)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spray-on tan
Time Frame: Follow-up 1 (3 weeks after baseline)
Number of spray-on tanning sessions in past month
Follow-up 1 (3 weeks after baseline)
Spray-on tan
Time Frame: Follow-up 2 (12 weeks after baseline)
Number of spray-on tanning sessions in past month
Follow-up 2 (12 weeks after baseline)
Sunless tanning creams
Time Frame: Follow-up 1 (3 weeks after baseline)
Number of times sunless tanning cream has been used in the past month
Follow-up 1 (3 weeks after baseline)
Sunless tanning creams
Time Frame: Follow-up 2 (12 weeks after baseline)
Number of times sunless tanning cream has been used in the past month
Follow-up 2 (12 weeks after baseline)

Collaborators and Investigators

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

Sponsor

Fox Chase Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Carolyn Heckman, Ph.D, Fox Chase Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2011

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

May 22, 2014

First Submitted That Met QC Criteria

May 22, 2014

First Posted (Estimate)

May 26, 2014

Study Record Updates

Last Update Posted (Actual)

July 3, 2018

Last Update Submitted That Met QC Criteria

June 29, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01CA154928-01 (U.S. NIH Grant/Contract)
  • 1R01CA154928 (U.S. NIH Grant/Contract)

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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