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例新的癌症病例中就有一例是在12-39岁的青少年或年轻人（AYA）中诊断出来的。两 女性和男性AYA癌症患者经历不育和性腺衰竭的风险增加， 在癌症治疗之前，通过有效的生育保留（FP）服务可以预防的影响。在 肿瘤学和生育的交叉点，肿瘤生育护理是讨论 新诊断的癌症患者的生殖风险，并支持计划生育服务的共同决策。 尽管有长期的临床指南，但肿瘤生育护理的使用率很低，因为我们目前缺乏可扩展的 干预措施以支持其在成人和儿科癌症护理环境中的实施。借鉴 实施科学，我们的跨学科团队在10个国家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， 可用性测试、试点测试和多组成部分远程保健肿瘤生育护理干预措施的定制。 干预的组成部分是：1）基于EHR的肿瘤生育需要筛查和转诊途径的虚拟 肿瘤生育中心; 2）通过中心进行远程医疗肿瘤生育咨询; 3）远程医疗肿瘤生育财务 通过Hub导航。拟议的TOC试验是一项18名成人和18名未成年人的阶梯式楔形分组随机试验， 三个卫生系统的儿科肿瘤诊所。我们将检验干预条件 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， 参与生殖风险咨询和生育能力保护服务，以满足患者的生育能力 目标）（目标1）和改善患者报告的结局以及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。为了缩短从研究发现到临床护理的时间间隔， 我们将在实施科学的指导下，使用混合方法评估干预措施的实施情况 框架（目标3）。目标为本课程的干预措施是创新的，因为它采用了多层次的方法， 目标、中心和辐射模型，将虚拟肿瘤生育中心与多机构肿瘤学诊所连接起来， 基于上下文匹配，可以在成人和儿科的不同EHR实例中实施 设置.该提案在采取科学知情的执行方法方面具有创新性， 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 按比例放大。影响：响应国会的儿童癌症生存，治疗，访问和研究 （星星）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），以及 解决癌症相关的经济困难（NOT-CA-22-045），该提案具有高临床应用潜力。 通过减少在获得肿瘤生育护理方面的显著不公平现象和使AYA癌症患者 参与护理，保护他们的生殖未来，改善癌症后的生活。