Modifying Young Adult Skin Cancer Risk and Protective Behaviors

Study Overview
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Brief Summary
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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.

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

Conditions
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Melanoma and Other Malignant Neoplasms of Skin

Intervention / Treatment
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* Behavioral: UV4.me2
* Behavioral: UV4.me
* Behavioral: E-Pamphlet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate to high risk for skin cancer Exclusion Criteria: Not able to speak English Past history of skin cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: E-Pamphlet<br>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<br>* 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.<br>|
| Active Comparator: Original UV4.me<br>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<br>* 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.<br>|
| Experimental: Enhanced UV4.me2<br>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<br>* 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: A mobile version of the site Incentives in the form of clickable coupons and links to free samples for sun protection products (e.g., sunscreen) Behavioral tracking and feedback, where users can set goals, track their progress, and receive tailored feedback<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reach: eligibility by recruitment source. | 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 | 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 | 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. | 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) | 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) | 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) | 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) | 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 | How frequently participants logged into the interventions will be recorded. | 1 month | 
| Cost of interventions | Total costs of the interventions will be assessed. | Through study completion |