Remote monitoring of cardiac function in childhood cancer survivors

远程监测儿童癌症幸存者的心脏功能

• 批准号: 10274206
• 负责人: Saro Armenian
• 金额: $ 22.23万
• 依托单位: BECKMAN RESEARCH INSTITUTE/CITY OF HOPE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10274206
• 关键词: Acoustics; Address; Adult; Age; Anthracycline; Biometry; Bluetooth; Breast Cancer survivor; COVID-19 pandemic; Cancer Center; Cancer Survivor; Cancer Survivorship; Cardiac; Cardiology; Cardiotoxicity; Cardiovascular system; Caring; Cellular Phone; Chest; Chronic Disease; Clinic; Clinical; Development; Devices; Diagnosis; Diagnostic; Diagnostic Imaging; Disease; Disease Management; Dose; EFRAC; Early Diagnosis; Echocardiography; Enrollment; Ensure; Face; Freedom; Guidelines; Healthcare; Heart Diseases; Heart Transplantation; Heart failure; High-Risk Cancer; Home; Immunotherapy; Knowledge; Left Ventricular Ejection Fraction; Long Term Survivorship; Long-Term Survivors; Longterm Follow-up; Lymphoma; Magnetic Resonance; Magnetic Resonance Imaging; Malignant Childhood Neoplasm; Measures; Medical; Monitor; Morbidity - disease rate; Myocardial dysfunction; Oncology; Outcome; Patients; Penetration; Periodicity; Persons; Pharmacology; Population; Prevention strategy; Prior Therapy; Radiation therapy; Reporting; Reproducibility; Research; Research Priority; Risk; Schools; Self Administration; Survivors; Technology; Testing; Time; Trastuzumab; Treatment-Related Cancer; Ventricular Remodeling; Visit; Wireless Technology; Work; base; biomechanical engineering; cancer risk; cancer therapy; cardiovascular disorder risk; cardiovascular risk factor; childhood cancer survivor; clinical care; clinical development; clinically relevant; community setting; cost; cost effective; cost effectiveness; early screening; follow-up; health economics; heart function; heart imaging; imaging approach; mHealth; markov model; mobile computing; mortality; multidisciplinary; point of care; primary care setting; prospective; remote monitoring; response; routine screening; screening; standard of care; survivorship

Abstract Cardiovascular complications are a leading cause of morbidity and mortality in survivors of childhood cancer. These survivors have a greater than four-fold risk of developing heart failure (HF) when compared to age- matched controls, and there is a strong dose-dependent association between anthracycline exposure and the risk of heart failure. Outcome following HF is poor, emphasizing the importance of early detection of cardiac dysfunction (e.g. abnormal left ventricular ejection fraction [EF]) with cardiac imaging and initiation of pharmacologic therapy prior to the development of clinically overt disease. Unfortunately, the period in time when survivors are at the greatest risk of HF also corresponds to the time when they are least engaged in risk- based survivorship care. New paradigms in clinical care and chronic disease management are needed for these survivors. Recent advances in mobile technology have facilitated the development of a new sector of mobile healthcare diagnostics (mHealth) that has the potential to combine the utility of standard of care cardiac monitoring by echocardiography with the accuracy of more advanced diagnostic imaging (cardiac magnetic resonance [CMR]). However, neither the reproducibility nor the cost-effectiveness of this mHealth technology for prospective clinic- or home-based cardiac monitoring in cancer survivors is known. To address these knowledge gaps, we will enroll 200 long-term childhood cancer survivors who previously underwent a one-time assessment of cardiac EF by echocardiography, CMR, and a handheld Bluetooth-enabled device (Vivio) to validate the accuracy of Vivio EF in the clinic setting, and to determine its reproducibility at home (Aim 1). We will also leverage the expertise of our investigative team to determine the cost-effectiveness of Vivio-based screening using Markov modeling (Aim 2). This study will: 1) provide an important follow-up timepoint that will confirm the accuracy of EF, as measured using Vivio, in anthracycline-exposed survivors; 2) demonstrate the reproducibility of self-administered home-based measures of cardiac function in survivors who may no longer be able to maintain survivorship-focused care at the cancer center; and 3) establish whether Vivio-based screening is a cost-effective alternative to current standard of care cardiac imaging approaches. Information obtained from the current study can be used to develop strategies that facilitate screening and management of cardiac dysfunction during cancer treatment, or after completion of therapy in other at-risk cancer populations (e.g. adult survivors of lymphoma treated with known cardiotoxic [anthracyclines, chest radiation] therapies or newer immunotherapies, adult survivors of breast cancer treated with anthracyclines and/or trastuzumab) who face similar challenges in long-term follow-up. The growing population of long-term cancer survivors at risk for cardiovascular disease makes development of screening and prevention strategies imperative, to ensure that these survivors live long and healthy lives well after completion of their cancer treatment.

摘要 心血管并发症是儿童癌症幸存者发病和死亡的主要原因。 与年龄相比，这些幸存者发生心力衰竭（HF）的风险超过4倍- 匹配的对照组，蒽环类药物暴露与 心力衰竭的风险。心力衰竭的预后较差，强调了早期发现心源性心脏病的重要性。 功能障碍（例如，左心室射血分数[EF]异常）伴心脏成像和启动 在临床上明显的疾病发展之前进行药物治疗。不幸的是， 当幸存者处于HF的最大风险时，也对应于他们最少参与风险的时间- 基于生存护理。需要临床护理和慢性病管理的新范式， 这些幸存者。移动的技术的最新进展促进了一个新部门的发展， 移动的医疗诊断（mHealth），有可能将标准护理心脏的效用与联合收割机结合起来 通过超声心动图监测，具有更先进的诊断成像（心脏磁共振成像）的准确性。 共振[CMR]）。然而，无论是可重复性还是这种mHealth技术的成本效益， 用于癌症幸存者的基于诊所或家庭的心脏监测是已知的。解决这些 知识差距，我们将招募200名长期儿童癌症幸存者，他们以前接受过一次性治疗。 通过超声心动图、CMR和手持式蓝牙设备（Vivio）评估心脏EF， 验证Vivio EF在临床环境中的准确性，并确定其在家中的重现性（目标1）。我们 我们还将利用我们调查团队的专业知识来确定基于Vivio的 使用马尔可夫模型进行筛选（目标2）。本研究将：1）提供一个重要的随访时间点， 证实EF的准确性，使用Vivio测量，在蒽环类药物暴露的幸存者; 2）证明 在那些可能不再需要进行自我管理的幸存者中， 能够在癌症中心维持以生存为中心的护理;以及3）确定是否基于Vivio 筛查是当前标准护理心脏成像方法的成本有效的替代方案。信息 从目前的研究中获得的信息可用于制定促进筛查和管理 癌症治疗期间或其他高危癌症人群完成治疗后的心功能不全 (e.g.接受已知心脏毒性[蒽环类药物、胸部放疗]治疗的淋巴瘤成年幸存者，或 较新的免疫疗法，用蒽环类和/或曲妥珠单抗治疗的乳腺癌成年幸存者）， 在长期后续行动中面临类似的挑战。越来越多的长期癌症幸存者面临着 心血管疾病使得筛查和预防策略的发展势在必行，以确保 这些幸存者在完成癌症治疗后健康长寿。