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Completed

NCT Number: NCT03313492

Modifying Young Adult Skin Cancer Risk and Protective Behaviors

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.

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Moderate to high risk for skin cancer

Exclusion criteria

  • Not able to speak English
  • Past history of skin cancer

Treatment and study plan

UV4.me2

Behavioral

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

UV4.me

Behavioral

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.

E-Pamphlet

Behavioral

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.

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Implementation: Web intervention use frequency

    Time frame: 1 month

    How frequently participants logged into the interventions will be recorded.

  6. Cost of interventions

    Time frame: Through study completion

    Total costs of the interventions will be assessed.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

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

Registry information

Official study title

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

Acronym: UV4me2

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Oct 18, 2017
Registry last updated
Sep 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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