Manne Sharon, Pagoto Sherry, Peterson Susan, Heckman Carolyn, Kashy Deborah, Berger Adam, Studts Christina, Negrón Rosalyn, Buller David, Paddock Lisa, Gallo Joseph, Kulik Alexandria, Frederick Sara, Pesanelli Morgan, Domider Mara, Grosso Marissa
Behavioral Sciences, Rutgers Cancer Institute of New Jersey, Rutgers, The State University of New Jersey, New Brunswick, NJ, United States.
Department of Allied Health Sciences, College of Agriculture, Health and Natural Resources, University of Connecticut, Storrs, CT, United States.
JMIR Res Protoc. 2023 Jan 24;12:e39640. doi: 10.2196/39640.
Individuals diagnosed with melanoma before the age of 40 years (young-onset melanoma survivors) and their first-degree relatives (FDRs) are a growing population at risk for developing recurrent melanoma or new melanomas. Regular surveillance using clinical skin examination (CSE) and skin self-examination (SSE) and engagement in preventive behaviors including sun protection are recommended. Given the growing population of survivors and their families who are at increased risk, it is surprising that no behavioral interventions have been developed and evaluated to improve risk-reduction behaviors.
We describe the rationale and methodology for a randomized controlled trial evaluating the efficacy of a Facebook intervention providing information, goal setting, and peer support to increase CSE, SSE, and sun protection for young-onset melanoma survivors and their FDRs.
Overall, 577 survivors and 577 FDRs will be randomly assigned to either the Young Melanoma Family Facebook Group or the Melanoma Family Healthy Lifestyle Facebook Group condition. Participants will complete measures of CSE, SSE, and sun protection, and mediator measures of attitudes and beliefs before and after the intervention. The primary aim is to evaluate the impact of the Young Melanoma Family Facebook intervention versus the Melanoma Family Healthy Lifestyle Facebook intervention on CSE, SSE frequency and comprehensiveness, and sun protection among FDRs. The secondary aims examine the efficacy of the Young Melanoma Family Facebook intervention on survivors' SSE frequency and comprehensiveness and sun protection behaviors and mechanisms of intervention efficacy for intervention impact on FDR and survivor outcomes. The exploratory aim is to evaluate the efficacy of the 2 interventions on perceived stress, physical activity, and healthy eating.
This project was funded by the National Institutes of Health (R01CA221854). The project began in May 2018, and recruitment started in January 2019. We anticipate completing enrollment by November 2023. Power calculations recommended a sample size of 577 survivors and 577 FDRs. Multilevel modeling treating family as the upper-level sampling unit and individual as the lower-level sampling unit will be the primary data analytic approach. Fixed effect predictors in these models will include condition, role, sex, all 2- and 3-way interactions, and covariates.
The Young Melanoma Family Facebook intervention aims to improve primary and secondary skin cancer prevention for young-onset melanoma survivors and their family members. The intervention's delivery via a popular, freely available social media platform increases its impact because of the potential for dissemination in many contexts. If efficacious, this program could be disseminated by dermatologist practices, public health or nonprofit organizations focused on melanoma, and existing melanoma and skin cancer Facebook groups, thereby expanding its reach. This project will produce a content library of posts and a moderation guide for others.
ClinicalTrials.gov NCT03677739; https://clinicaltrials.gov/ct2/show/NCT03677739.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39640.
40岁之前被诊断为黑色素瘤的个体（年轻发病黑色素瘤幸存者）及其一级亲属（FDRs）是患复发性黑色素瘤或新发黑色素瘤风险不断增加的群体。建议通过临床皮肤检查（CSE）和皮肤自我检查（SSE）进行定期监测，并采取包括防晒在内的预防行为。鉴于幸存者及其家庭的风险增加且数量不断增长，令人惊讶的是，尚未开发和评估任何行为干预措施来改善降低风险的行为。
我们描述了一项随机对照试验的基本原理和方法，该试验评估了一个Facebook干预措施的效果，该干预措施提供信息、设定目标和同伴支持，以增加年轻发病黑色素瘤幸存者及其FDRs的CSE、SSE和防晒行为。
总体而言，577名幸存者和577名FDRs将被随机分配到年轻黑色素瘤家庭Facebook群组或黑色素瘤家庭健康生活方式Facebook群组。参与者将在干预前后完成CSE、SSE和防晒措施，以及态度和信念的中介措施。主要目的是评估年轻黑色素瘤家庭Facebook干预与黑色素瘤家庭健康生活方式Facebook干预对FDRs的CSE、SSE频率和全面性以及防晒的影响。次要目的是研究年轻黑色素瘤家庭Facebook干预对幸存者SSE频率和全面性以及防晒行为的效果，以及干预效果对FDR和幸存者结局的干预效果机制。探索性目的是评估这两种干预措施对感知压力、身体活动和健康饮食的效果。
该项目由美国国立卫生研究院资助（R01CA221854）。该项目于2018年5月开始，招募工作于2019年1月开始。我们预计到2023年11月完成招募。功效计算建议样本量为577名幸存者和577名FDRs。将家庭作为上层抽样单位、个体作为下层抽样单位的多层建模将是主要的数据分析方法。这些模型中的固定效应预测变量将包括组别、角色、性别、所有二元和三元交互作用以及协变量。
年轻黑色素瘤家庭Facebook干预旨在改善年轻发病黑色素瘤幸存者及其家庭成员的原发性和继发性皮肤癌预防。通过一个受欢迎的、免费的社交媒体平台进行干预，因其在多种情况下传播的可能性而增加了其影响力。如果有效，该项目可以由皮肤科医生诊所、专注于黑色素瘤的公共卫生或非营利组织以及现有的黑色素瘤和皮肤癌Facebook群组进行传播，从而扩大其覆盖范围。该项目将为其他人生成一个帖子内容库和一份审核指南。
ClinicalTrials.gov NCT03677739；https://clinicaltrials.gov/ct2/show/NCT03677739。
国际注册报告识别码（IRRID）：DERR1-
