Modifying Young Adult Skin Cancer Risk and Protective Behaviors (UV4me2)

September 27, 2022 updated by: Dr. Carolyn Heckman, Ph.D, Rutgers, The State University of New Jersey

Modifying Young Adult Skin Cancer Risk and Protective Behaviors (UV4.me2): A Hybrid Type 2 Dissemination/Effectiveness Trial

Skin cancer is the most common cancer and can be deadly, debilitating, damaging, and disfiguring, yet is highly preventable. In 2014, the US Surgeon General made a call to action about the "major public health problem" of skin cancer, noting potential contributions of behavioral science and education, and a need for investments in such efforts. Almost five million Americans are treated for skin cancer annually, and incidence is rising. Risk factors for melanoma and non-melanoma skin cancers include personal or family history of skin cancer, certain physical characteristics (e.g., fair skin, numerous moles), as well as excessive ultraviolet (UV) radiation exposure. Our work shows that skin cancer risk behaviors, including sunburns, indoor tanning, and lack of protection peak at age 25. Thus, young adulthood is an important window for skin cancer risk reduction interventions. However, young adults tend to be resistant to public health recommendations because, as a group, they perceive themselves as having more immediate priorities than disease prevention, that the consequences of their current health behaviors are in the distant future, and they also tend to be experimenters and risk-takers highly influenced by peers.

The principal investigator developed a web-based intervention (UV4.me) that was found to significantly decrease UV exposure and increase skin protection behaviors among young adults in a randomized controlled trial of nearly 1000 participants.

The objective of this project is to investigate the reach, effectiveness, implementation, maintenance, and cost of an enhanced version of that web intervention (UV4.me2) in a large national randomized controlled trial. The ultimate goal is to improve the skin cancer protection behaviors (and potentially decrease skin cancer incidence) among a national sample of young adults at moderate to high risk of developing skin cancer.

Primary Aim 1. To enhance and determine intervention reach (i.e., enrollment, representativeness).

Primary Aim 2. To determine the effectiveness of the enhanced intervention.

Secondary Aim 1. To determine maintenance of the UV4.m4 and UV4.me2 interventions through evaluation at 6 and 12-month follow-up.

Secondary Aim 2. To determine intervention implementation by young adults.

Secondary Aim 3. To determine the costs of the UV4.me and UV4.me2 interventions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1746

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
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey
    • 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:

  • Moderate to high risk for skin cancer

Exclusion Criteria:

  • Not able to speak English
  • Past 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: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: E-Pamphlet
A free non-interactive e-pamphlet ("Skin Cancer Prevention and Early Detection" from the American Cancer Society) will be accessible via our website.
Behavioral: E-Pamphlet
A free non-interactive e-pamphlet ("Skin Cancer Prevention and Early Detection" from the American Cancer Society). Includes information on skin cancer risk and prevention.
ACTIVE_COMPARATOR: Original UV4.me
Participants will view the original UV4.me web intervention, which includes educational modules, personalized responses to quizzes, information on skin type and burn risk, UV damage photo of similar individuals, avatar activity, age progression images, personal risk calculator, SPF (sun protection factor) calculator. The website content will remain the same, with the exception of updating photos, statistics, and cultural references for the current year.
Behavioral: UV4.me
Original version of the UV4.me website, which offers education and tailored responses to interactive quizzes about current sun protective behaviors and barriers to engaging in sun protective behaviors.
EXPERIMENTAL: Enhanced UV4.me2
Participants will view an enhanced version of the UV4.me website. Improvements to the website are based on user feedback from the original UV4.me trial, as well as reviews and models of effective e-Health interventions and implementation strategies.
Behavioral: UV4.me2

UV4.me2 is an enhanced version of the original UV4.me web intervention and features the many of the same educational material and interactive components. New features/strategies for reach, effectiveness, and implementation include:

  1. A mobile version of the site
  2. Incentives in the form of clickable coupons and links to free samples for sun protection products (e.g., sunscreen)
  3. Behavioral tracking and feedback, where users can set goals, track their progress, and receive tailored feedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reach: eligibility by recruitment source.
Time Frame: 18 months
The number of participants who are eligible for the study by recruitment source (i.e., skin protection organizations, Google Adwords, Facebook ads, consumer research panel, word of mouth).
18 months
Efficacy: Sun protection behaviors
Time Frame: Change from baseline to 3 months
Skin cancer-related behavioral outcomes will initially be assessed at baseline and 3 months later. Sun protection will be measured using a self-report scale assessing behaviors such as sunscreen use and shade seeking.
Change from baseline to 3 months
Efficacy: UV exposure behaviors
Time Frame: Change from baseline to 3 months
Skin cancer-related behavioral outcomes will initially be assessed at baseline and 3 months later. UV exposure will be measured using a self-report scale assessing how many times in the past month the subject engaged in behaviors such as sunbathing and using a tanning bed/booth.
Change from baseline to 3 months
Reach: enrollment by recruitment source.
Time Frame: 18 months
The number of participants who enroll in the study by recruitment source (i.e., skin protection organizations, Google Adwords, Facebook ads, consumer research panel, word of mouth).
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maintenance of skin cancer-related behavioral outcomes (sun protection)
Time Frame: 6 months
Sun protection behaviors will be assessed at 6 months using a self-report scale assessing behaviors such as sunscreen use and shade seeking.
6 months
Maintenance of skin cancer-related behavioral outcomes (sun protection)
Time Frame: 12 months
Sun protection behaviors will be assessed at 12 months using a self-report scale assessing behaviors such as sunscreen use and shade seeking.
12 months
Maintenance of skin cancer-related behavioral outcomes (UV exposure)
Time Frame: 6 months
UV exposure will be assessed at 6 months using a self-report scale assessing how many times in the past month the subject engaged in behaviors such as sunbathing and using a tanning bed/booth.
6 months
Maintenance of skin cancer-related behavioral outcomes (UV exposure)
Time Frame: 12 months
UV exposure will be assessed at 12 months using a self-report scale assessing how many times in the past month the subject engaged in behaviors such as sunbathing and using a tanning bed/booth.
12 months
Implementation: Web intervention use frequency
Time Frame: 1 month
How frequently participants logged into the interventions will be recorded.
1 month
Cost of interventions
Time Frame: Through study completion
Total costs of the interventions will be assessed.
Through study completion

Collaborators and Investigators

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

Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Cancer Institute (NCI)
University of Pennsylvania
RTI International
ITX Corporation

Investigators

  • Principal Investigator: Carolyn Heckman, PhD, Rutgers, the State University of New Jersey

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 (ACTUAL)

September 7, 2018

Primary Completion (ACTUAL)

July 31, 2019

Study Completion (ACTUAL)

July 31, 2020

Study Registration Dates

First Submitted

October 4, 2017

First Submitted That Met QC Criteria

October 13, 2017

First Posted (ACTUAL)

October 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 30, 2022

Last Update Submitted That Met QC Criteria

September 27, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro2018001543
  • R01CA204271 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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 Melanoma and Other Malignant Neoplasms of Skin

Clinical Trials on E-Pamphlet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe