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

对青少年和年轻成年癌症患者的远程医疗肿瘤生育护理干预的评估：阶梯式楔形集群随机对照试验

• 批准号: 10587766
• 负责人: Hui-Chun Irene Su
• 金额: $ 63.24万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-12-01 至 2027-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10587766
• 关键词: Achievement; Address; Adolescent; Adolescent and young adult cancer patients; Adult; California; Cancer Patient; Cancer Survivor; Cancer Survivorship; Caring; Childhood; Clinic; Clinical; Clinical Trials; Cluster randomized trial; Collaborations; Conflict (Psychology); Congresses; Counseling; Data; Development; Diagnosis; Electronic Health Record; Equity; Evaluation; Evidence based practice; Failure; Family; Female Adolescents; Fertility; Financial Hardship; Frequencies; Future; Goals; Guidelines; Health Services; Health system; Incidence; Infertility; Institution; Intervention; Intervention Studies; Knowledge; Late Effects; Life; Male Adolescents; Malignant Childhood Neoplasm; Malignant Neoplasms; Medical; Methods; Modeling; Newly Diagnosed; Oncologist; Oncology; Outcome; Pathway interactions; Patient Outcomes Assessments; Patient Preferences; Patients; Pediatric Oncology; Persons; Policies; Procedures; Process; Qualitative Methods; Quality of life; Randomized, Controlled Trials; Recommendation; Reporting; Research; Risk; Scanning; Services; Site; Specialist; Technology; Testing; Time; access disparities; aged; barrier to care; cancer care; cancer diagnosis; cancer therapy; care delivery; clinical care; effectiveness evaluation; experience; fertility preservation; future implementation; hybrid type 1 design; implementation evaluation; implementation framework; implementation intervention; implementation science; improved; innovation; multi-component intervention; multidisciplinary; novel; oncofertility; patient engagement; patient oriented; pilot test; preservation; prevent; primary outcome; psychosocial; remote delivery; reproductive; scale up; shared decision making; study population; telehealth; tool; treatment as usual; uptake; usability; virtual; young adult

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.

每 20 个新癌症病例中就有 1 个是在 12-39 岁的青少年或年轻人 (AYA) 中诊断出来的。 女性和男性 AYA 癌症患者不孕和性腺衰竭的风险增加，这对晚期患者来说是毁灭性的 在癌症治疗之前通过有效的生育力保存（FP）服务可以预防这些影响。 肿瘤学和生育力的交叉点，肿瘤生育力护理是讨论的循证实践 新诊断癌症患者的生殖风险并支持 FP 服务的共同决策。 尽管有长期的临床指南，但由于我们目前缺乏可扩展的治疗，肿瘤生育护理的采用率很低 借鉴其在成人和儿童癌症护理环境中的干预措施。 实施科学，我们的跨学科团队对 10 个领域进行了系统的环境扫描 多样化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， 多组件远程医疗肿瘤生育护理 (TOC) 干预的可用性测试、试点测试和定制。 干预措施包括：1) 基于 EHR 的肿瘤生育需求筛查和虚拟转诊途径 肿瘤生育中心；2) 通过该中心提供远程医疗肿瘤生育咨询；以及 3) 远程医疗肿瘤生育财务 拟议的 TOC 试验是一项针对 18 名成人的阶梯式楔形集群随机试验。 我们将测试三个卫生系统的儿科肿瘤诊所的假设。 将与参与目标一致的肿瘤生育护理的患者比例增加相关（即， 参与符合患者生育能力的生殖风险咨询和生育力保存服务 目标）（目标 1）并改善患者报告的结果和以患者为中心的目标的实现（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， 我们将使用以实施科学为指导的混合方法实施来评估干预措施 TOC 干预措施因其多层次的方法、医疗财务困难而具有创新性。 目标、中心和辐射模型将虚拟肿瘤生育中心与多机构肿瘤诊所和重点联系起来 上下文契合，可以在成人和儿童中实现单独的 EHR 实例 该提案在采取科学知情的实施方法方面具有创新性，考虑到了这一点。 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 扩大影响：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 NOSI (NOT-CA-21-043) 和 解决与癌症相关的经济困难（NOT-CA-22-045），该提案具有高度临床潜力 通过减少获得肿瘤生育护理方面的显着不平等并为 AYA 癌症患者提供帮助来产生影响 参与保护其生殖未来并改善癌症后生活的护理。