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.

在12-39岁的青少年或年轻人（AYA）中，每20例新的癌症病例中的一个被诊断出来。两个都 雌性和雄性AYA癌症患者患有不育和性腺衰竭的风险，迟到 在癌症治疗之前可以通过有效的生育能力（FP）服务来预防的影响。 肿瘤学与生育的交集，肿瘤性护理是基于证据的实践 新诊断的癌症患者的生殖风险并支持FP服务的共同决策。 尽管长期以来临床指南，但良好的护理吸收率很低，因为我们目前缺乏可扩展性的 支持其在成人和小儿癌症护理环境中实施的干预措施。吸引 实施科学，我们的跨学科团队在10期进行了系统的环境扫描 多样化的卫生系统证实了先前对护理障碍的研究，并导致了发展的发展 可用性测试，试点测试和量身定制的多组件远程医疗保健（TOC）干预措施。 干预组件是：1）基于EHR的副产品需求屏幕和转介途径到虚拟 Oncofertility Hub; 2）通过枢纽远程医疗良好咨询；和3）远程医疗保健财务财务 通过集线器导航。拟议的TOC试验是一个阶梯楔形群集随机试验，对18名成人和 小儿肿瘤学诊所跨三个卫生系统。我们将测试干预条件的假设 将与参与目标符合良好性护理的患者比例增加有关（即 参与符合患者生育能力的生殖风险咨询和生育保存服务 目标）（目标1），改善了患者报告的结果和以患者为中心的目标的实现（AIM 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， 我们将使用由实施科学指导的混合方法评估干预实施 框架（目标3）。 TOC干预对其多层次方法，医疗财务困难具有创新性 Target，Hub和Spoke模型与多机构肿瘤学诊所桥接虚拟型福用中心，并重点 在上下文拟合下，可以跨单独的EHR实例以及成人和小儿实施 设置。该提案在采用实施科学方面的方法方面具有创新性 政策，组织环境和患者偏爱评估未来有效性和实施 扩展。影响：对国会的儿童癌症生存，治疗，获取和研究的反应敏感 （Star）2018年的ACT和NCI在与癌症有关的护理中使用远程医疗的NOSIS（非CA-21-043）和 解决与癌症相关的金融困难（非CA-22-045），该提案有可能获得高临床 通过减少获得良好型护理的严重不平等并使AYA癌症患者的影响来影响 从事保留复制期货并改善癌症后生活的护理。