Randomized Trial of Inpatient Palliative Care for Patients with Hematologic Malignancies Undergoing Hematopoietic Stem Cell Transplantation

项目摘要/摘要 概述：这项研究的目标是证明住院姑息治疗与反式治疗相结合的疗效。 植物护理改善恶性血液病患者的生活质量和情绪 造血干细胞移植(HCT)及其护理人员。 背景：接受同种异体移植的患者在治疗期间承受着巨大的生理和心理负担。 他们的移植住院时间为3-4周，50%-70%的人报告有中度至重度的恶心、疲劳、腹泻、 和疼痛，超过40%的人报告说有明显的抑郁和焦虑症状。重要的是，患者的生活质量下降 HCT期间的变化可预测HCT后的生活质量和心理困扰。照顾者(即家人和 接受同种异体移植的患者在他们所爱的人的移植期间和之后也会在情绪上挣扎。去- 尽管这些人经历了负担，但缺乏干预措施来改善他们的生活质量和护理。我们 完成了一项关于住院患者综合姑息治疗和移植治疗的单中心随机试验。 患者的生活质量、症状负担、抑郁水平均有显著改善。 Sion，以及在HCT期间的焦虑。值得注意的是，干预的效果在三个月和六个月后持续。 HCT能改善患者的抑郁和创伤后应激症状。病人的照顾者跑- 接受干预的受试者报告称，他们的应对方式和抑郁情绪有所改善。因此，这是第一次审判 建立住院患者姑息和移植综合护理的可行性和初步疗效。 证明恶性血液病患者及其照顾者的预后。 研究计划：我们建议进行一项关于住院患者综合姑息治疗和反式治疗的多点随机试验。 接受HCT的恶性血液病患者中植物护理与单独移植护理的比较。初级阶段 这项研究的目的是明确证明住院姑息护理在改善患者和 CARGIER在一项多点试验中报告了结果，该试验涉及大量和更多样化的患者群体。我们还将 评估姑息护理干预对参与者报告的生活质量和心理结果的影响 后HCT时代。最后，我们将探索住院患者综合姑息和治疗的潜在调节因素和调节因素。 移植护理模式对患者报告的生活质量的影响。 环境：该项目将在马萨诸塞州总医院弗雷德·哈钦森癌症研究中心进行。 搜索中心和迈阿密大学。这些地方有姑息治疗和移植的经验， 基础设施，以及进行这项试验的流程。MGH研究团队拥有开发和开发 测试实体肿瘤和恶性血液疾病患者的综合姑息护理模式，以确保 跨研究地点的姑息关怀干预的成功实施和评估。 研究的相关性：该项目将为未来的实施和 HCT患者接受姑息和移植综合护理的推广试验。

PROJECT SUMMARY/ABSTRACT Overview: The goal of this study is to demonstrate the efficacy of inpatient palliative care integrated with trans- plant care for improving quality of life (QOL) and mood of patients with hematological malignancies undergoing hematopoietic stem cell transplantation (HCT) and their caregivers. Background: Patients undergoing HCT endure an immense physical and psychological symptom burden during their 3-4 week transplant hospitalization with 50-70% reporting moderate to severe nausea, fatigue, diarrhea, and pain, and over 40% reporting significant depression and anxiety symptoms. Importantly, patients' QOL de- terioration during HCT predicts their QOL and psychological distress post-HCT. Caregivers (i.e. family and friends) of patients undergoing HCT also struggle emotionally during and after their loved one's transplant. De- spite the burden experienced by these individuals, interventions are lacking to improve their QOL and care. We completed a single center randomized trial of inpatient integrated palliative and transplant care in patients un- dergoing HCT and demonstrated clinically significant improvements in patients' QOL, symptom burden, depres- sion, and anxiety during HCT. Notably, the effects of the intervention were sustained three and six months post- HCT with improvement in patients' depression and post-traumatic stress symptoms. Caregivers of patients ran- domized to the intervention reported improvements in their coping and depression. Thus, this is the first trial to establish both the feasibility and preliminary efficacy of inpatient integrated palliative and transplant care in im- proving outcomes of patients with hematologic malignancies and their caregivers. Research Plan: We propose to conduct a multi-site randomized trial of inpatient integrated palliative and trans- plant care versus transplant care alone in patients with hematologic malignancies undergoing HCT. The primary goal of this study is to demonstrate definitively the efficacy of inpatient palliative care for improving patient and caregiver reported outcomes in a multi-site trial with a large and more diverse patient population. We will also assess the impact of the palliative care intervention on participant-reported QOL and psychological outcomes post-HCT. Lastly, we will explore potential mediators and moderators of the inpatient integrated palliative and transplant care model on patient-reported QOL. Environment: This project will be conducted at Massachusetts General Hospital, Fred Hutchinson Cancer Re- search Center, and the University of Miami. These sites have the palliative care and transplant experience, infrastructure, and processes to conduct this trial. The MGH research team has the expertise in developing and testing integrated palliative care models for patients with solid tumors and hematologic malignancies to ensure the successful implementation and evaluation of the palliative care intervention across study sites. Relevance of Research: This project will establish the essential foundation of a future implementation and dissemination trial of inpatient integrated palliative and transplant care for patients undergoing HCT.