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临床试验/NCT03313492
NCT03313492已完成不适用

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

Rutgers, The State University of New Jersey4 个研究点 分布在 1 个国家目标入组 1,746 人开始时间: 2018年9月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,746
试验地点
4
主要终点
Efficacy: UV exposure behaviors

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Moderate to high risk for skin cancer

排除标准

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

结局指标

主要结局

Efficacy: UV exposure behaviors

时间窗: 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.

时间窗: 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

时间窗: 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.

时间窗: 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).

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Carolyn Heckman, Ph.D

Associate Professor

Rutgers, The State University of New Jersey

研究点 (4)

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