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Clinical Trials/NCT03313492
NCT03313492
Completed
Not Applicable

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

Rutgers, The State University of New Jersey2 sites in 1 country1,746 target enrollmentSeptember 7, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Melanoma and Other Malignant Neoplasms of Skin
Sponsor
Rutgers, The State University of New Jersey
Enrollment
1746
Locations
2
Primary Endpoint
Efficacy: UV exposure behaviors
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 7, 2018
End Date
July 31, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Carolyn Heckman, Ph.D

Associate Professor

Rutgers, The State University of New Jersey

Eligibility Criteria

Inclusion Criteria

  • Moderate to high risk for skin cancer

Exclusion Criteria

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

Outcomes

Primary Outcomes

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.

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).

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.

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).

Secondary Outcomes

  • Maintenance of skin cancer-related behavioral outcomes (sun protection)(12 months)
  • Cost of interventions(Through study completion)
  • Maintenance of skin cancer-related behavioral outcomes (UV exposure)(12 months)
  • Implementation: Web intervention use frequency(1 month)

Study Sites (2)

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