Evaluation of a telehealth oncofertility care intervention in adolescent and young adult cancer patients: a stepped wedge cluster randomized controlled trial

每20个新的癌症病例中就有一个在12-39岁的青春期或青壮年(Aya)被确诊。两者都有 女性和男性Aya癌症患者经历不孕不育和性腺衰竭的风险增加，毁灭性的晚期 癌症治疗前可通过有效的生育保护(FP)服务预防的影响。在… 肿瘤学和生育学的交叉，肿瘤生育护理是以循证实践为基础的讨论 与新诊断的癌症患者的生殖风险，并支持关于计划生育服务的共享决策。 尽管长期存在临床指南，但肿瘤生育护理接受率很低，因为我们目前缺乏可扩展的 支持其在成人和儿童癌症护理环境中实施的干预措施。在上面绘制 实施科学，我们的跨学科团队在10个领域进行了系统的环境扫描 不同的卫生系统，证实了先前关于护理障碍的研究，并导致了发展， 多组件远程保健肿瘤生育护理(TOC)干预措施的可用性测试、中试测试和定制。 干预部分包括：1)基于EHR的肿瘤生育需求筛选和转诊路径 肿瘤生育中心；2)通过该中心进行远程保健肿瘤生育咨询；以及3)远程保健肿瘤生育财务 在枢纽中导航。拟议的TOC试验是一项阶梯式楔形整群随机试验，共有18名成年人和 三个卫生系统的儿科肿瘤科诊所。我们将检验干预条件的假设 将与参与符合目标的肿瘤生育护理的患者比例增加相关(即， 从事符合患者生育能力的生殖风险咨询和生育保护服务 目标)(目标1)和改善患者报告的结果和实现以患者为中心的目标(目标2)， 与通常的护理控制条件相比。为了减少从研究发现到临床护理的时间滞后， 我们将以实施科学为指导，使用混合方法评估干预实施情况 框架(目标3)。TOC干预是创新的，因为它的多层次方法，医疗经济困难 目标、中心和辐条模式将虚拟肿瘤生育中心与多机构肿瘤学诊所和焦点连接起来 支持跨单独的EHR实例以及在成人和儿童中实施的上下文匹配 设置。该提案在采取执行科学知情的方法方面具有创新性，考虑到 政策、组织背景和患者偏好，以评估未来的有效性和实施情况 放大。影响：响应国会的儿童癌症生存、治疗、获取和研究 (STAR)2018年法案和NCI关于在癌症相关护理中使用远程医疗的通知(非-CA-21-043)和 解决与癌症相关的经济困难(非-CA-22-045)，这项建议具有很高的临床应用潜力 通过减少在获得肿瘤生育护理方面的重大不平等并使癌症患者能够 从事保护他们的生殖未来和改善癌症后生活的护理。

One of every 20 new cancer cases is diagnosed in an adolescent or young adult (AYA) aged 12–39 years. Both female and male AYA cancer patients experience increase risks of infertility and gonadal failure, devastating late effects which are preventable through effective fertility preservation (FP) services prior to cancer treatment. At the intersection of oncology and fertility, oncofertility care is the evidence-based practice of discussing reproductive risks with newly diagnosed cancer patients and supporting shared decision-making on FP services. Despite longstanding clinical guidelines, oncofertility care uptake is low because we currently lack scalable interventions to support its implementation in adult and pediatric cancer care settings. Drawing on implementation science, our transdisciplinary team conducted systematic environmental scans across 10 diverse health systems which corroborated prior research on barriers to care and led to the development, usability testing, pilot testing and tailoring of the multi-component telehealth oncofertility care (TOC) intervention. Intervention components are: 1) EHR-based oncofertility needs screen and referral pathway to a virtual oncofertility hub; 2) telehealth oncofertility counseling through the hub; and 3) telehealth oncofertility financial navigation through the hub. The proposed TOC trial is a stepped wedge cluster randomized trial of 18 adult and pediatric oncology clinics across three health systems. We will test the hypotheses that the intervention condition will be associated with increased proportion of patients who engage in goal-concordant oncofertility care (i.e., engagement in reproductive risk counseling and fertility preservation services that meet the patient’s fertility goals) (Aim 1) and improved patient-reported outcomes and achievement of patient-centered goals (Aim 2), compared to the usual care control condition. To decrease the time lag from research discovery to clinical care, we will evaluate intervention implementation using mixed methods guided by implementation science frameworks (Aim 3). The TOC intervention is innovative for its multi-level approach, medical financial hardship target, hub and spoke model bridging a virtual oncofertility hub with multi-institutional oncology clinics, and focus on contextual fit that enables implementation across separate EHR instances and in both adult and pediatric settings. The proposal is innovative in taking an implementation science-informed approach that considers policy, organizational context, and patient preference to evaluate effectiveness and implementation for future scale-up. IMPACT: Responsive to Congress’ Childhood Cancer Survivorship, Treatment, Access and Research (STAR) Act of 2018 and NCI’s NOSIs on use of telehealth in cancer-related care (NOT-CA-21-043) and addressing cancer-related financial hardship (NOT-CA-22-045), this proposal has the potential for high clinical impact through reducing significant inequities in access to oncofertility care and enabling AYA cancer patients to engage in care that preserves their reproductive futures and improves life after cancer.