Stapleton Jerod L, Manne Sharon L, Pagoto Sherry L, Leip Allison, Greene Kathryn, Hillhouse Joel J, Merritt Allison S, Shelton Brent J
Markey Cancer Center, College of Public Health, University of Kentucky, Lexington, KY, United States.
Rutgers Cancer Institute of New Jersey, Rutgers Robert Wood Johnson Medical School, Rutgers, The State University of New Jersey, New Brunswick, NJ, United States.
JMIR Res Protoc. 2024 Mar 19;13:e56562. doi: 10.2196/56562.
Rates of melanoma have increased dramatically in the United States over the past 25 years, and it has become among the most prevalent cancers for young adult women. Intentional skin tanning leads to a pattern of intense and intermittent UV radiation exposure that is associated with increased risk of melanoma. Frequent tanning is most common among young women and is linked to a variety of sociocultural pressures that negatively impact body image and drive appearance control behaviors. Unfortunately, there are no established interventions designed for frequent tanners. This intervention addresses this gap with unique content informed by body image and acceptance-based interventions. The intervention is delivered using Facebook secret groups, an approach designed to support behavior change and ensure scalability.
This study aims to describe the rationale and methodology of a randomized controlled trial of a melanoma prevention program targeting young women engaged in frequent indoor or outdoor UV tanning.
Participants are women aged 18-25 years who report high-risk tanning (ie, at least 10 indoor tanning sessions in the past 12 months or 10 outdoor sessions in the previous summer). After recruitment and screening, participants completed a baseline survey and were randomly assigned to receive the intervention or an attention-matched control condition. Both conditions were 8-week-long Facebook groups (approximately 25 members each) with daily posting of content. Follow-up surveys are administered at 3, 8, and 18 months after baseline. The primary trial outcome is the combined number of indoor and outdoor tanning sessions reported at the 8-month follow-up. Hypothesized intervention mediators are assessed at the 3-month follow-up.
This project was funded by a National Cancer Institute award (R01 CA218068), and the trial procedures were approved by the University of Kentucky Institutional Review Board in February 2020. Trial recruitment and enrollment occurred in 6 waves of data collection, which started in February 2022 and closed in May 2023. The study is closed to enrollment but remains open for follow-ups, and this protocol report was prepared before data analyses. As of February 2024, all participants have completed the 8-month follow-up assessment, and data collection is scheduled to close by the end of 2024 after the collection of the 18-month follow-up.
This trial will contribute unique knowledge to the field of skin cancer prevention, as no fully powered trials have examined the efficacy of an intervention designed for frequent indoor or outdoor tanning. The trial may also contribute evidence of the value in translating principles of body image and acceptance-based interventions into the field of skin cancer prevention and beyond. If successful, the use of the Facebook platform is intended to aid in dissemination as it provides a way to embed the intervention into individuals' everyday routines.
ClinicalTrials.gov NCT03441321; https://clinicaltrials.gov/study/NCT03441321.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56562.
在过去25年里,美国黑色素瘤发病率急剧上升,它已成为年轻成年女性中最常见的癌症之一。故意晒黑会导致强烈且间歇性的紫外线辐射暴露模式,这与黑色素瘤风险增加有关。频繁晒黑在年轻女性中最为常见,并且与多种社会文化压力相关,这些压力会对身体形象产生负面影响并促使出现外貌控制行为。不幸的是,目前尚无专门针对频繁晒黑者的既定干预措施。本干预措施通过基于身体形象和接纳的干预措施所提供的独特内容来填补这一空白。该干预措施通过脸书秘密群组实施,这是一种旨在支持行为改变并确保可扩展性的方法。
本研究旨在描述一项针对经常进行室内或室外紫外线晒黑的年轻女性的黑色素瘤预防项目的随机对照试验的基本原理和方法。
参与者为年龄在18至25岁之间且报告有高风险晒黑行为的女性(即过去12个月内至少进行10次室内晒黑或前一个夏天进行10次室外晒黑)。在招募和筛选后,参与者完成基线调查,并被随机分配接受干预或注意力匹配的对照条件。两种条件均为为期8周的脸书群组(每个群组约25名成员),每天发布内容。在基线后的3个月、8个月和18个月进行随访调查。主要试验结果是在8个月随访时报告的室内和室外晒黑次数总和。在3个月随访时评估假设的干预调节因素。
该项目由美国国立癌症研究所的一项拨款(R01 CA218068)资助,试验程序于2020年2月获得肯塔基大学机构审查委员会批准。试验招募和入组分6波进行数据收集,始于2022年2月,于2023年5月结束。该研究已停止招募但仍开放进行随访,本方案报告是在数据分析之前编写的。截至2024年2月,所有参与者均已完成8个月随访评估,数据收集计划在2024年底收集18个月随访数据后结束。
本试验将为皮肤癌预防领域贡献独特知识,因为尚无充分有力的试验检验针对经常进行室内或室外晒黑的干预措施的疗效。该试验还可能为将身体形象和基于接纳的干预原则应用于皮肤癌预防及其他领域的价值提供证据。如果成功,脸书平台的使用旨在促进传播,因为它提供了一种将干预措施融入个人日常生活的方式。
ClinicalTrials.gov NCT03441321;https://clinicaltrials.gov/study/NCT03441321。
国际注册报告识别码(IRRID):DERR1-10.2196/56562。