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

接受造血干细胞移植的血液恶性肿瘤患者住院姑息治疗的随机试验

• 批准号: 9980805
• 负责人: Areej El-Jawahri
• 金额: $ 44.03万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-09 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9980805
• 关键词: Address; Anxiety; Caregivers; Caring; Clinical; Communication; Complex; Consult; Data; Deterioration; Diarrhea; Distress; Emotional; Ensure; Environment; Evaluation; Family; Fatigue; Foundations; Friends; Fright; Future; General Hospitals; Goals; Health Status; Hematologic Neoplasms; Hematopoietic Stem Cell Transplantation; High Dose Chemotherapy; Hospitalization; Individual; Infrastructure; Inpatients; Intervention; Intervention Studies; Length of Stay; Life; Malignant Neoplasms; Massachusetts; Mediating; Mediator of activation protein; Mental Depression; Modeling; Moods; Morbidity - disease rate; Mucositis; Nausea; Nausea and Vomiting; Oncology; Outcome; Pain; Palliative Care; Participant; Patient Care; Patient Isolation; Patient-Focused Outcomes; Patients; Population; Positioning Attribute; Procedures; Process; Quality of life; Randomized; Reporting; Research; Research Project Grants; Risk; Site; Solid Neoplasm; Stem cell transplant; Symptoms; Testing; Toxic effect; Training; Transplantation; Universities; Visit; anxiety symptoms; clinically significant; coping; curative treatments; depressive symptoms; dissemination trial; efficacy testing; end of life care; expectation; experience; implementation trial; improved; improved outcome; intervention effect; loved ones; medical specialties; multi-site trial; outcome forecast; palliative; patient population; physical symptom; post-transplant; post-traumatic symptoms; psychologic; psychological distress; psychological outcomes; psychological symptom; randomized trial; reduce symptoms; standard of care; treatment strategy

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.

项目总结/摘要 概述：本研究的目的是证明住院患者姑息治疗结合反式- 植物护理改善血液系统恶性肿瘤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HCT的患者在治疗期间承受着巨大的身体和心理症状负担。 他们3-4周的移植住院治疗，50-70%的患者报告中度至重度恶心、疲劳、腹泻， 超过40%的人报告有明显的抑郁和焦虑症状。重要的是，患者的QOL- HCT期间的恶化可预测HCT后的生活质量和心理困扰。照顾者（即家人和 接受HCT的患者的朋友们在他们所爱的人的移植期间和之后也在情感上挣扎。去- 尽管这些个体经历了负担，但缺乏干预措施来改善他们的QOL和护理。我们 完成了一项单中心随机试验，在未接受姑息治疗和移植治疗的患者中进行住院综合治疗， 进行HCT，并在患者的QOL、症状负担、抑郁、 HCT期间的锡永和抑郁。值得注意的是，干预的效果持续了三个月和六个月后， HCT可改善患者的抑郁和创伤后应激症状。病人的护理人员跑了- 接受干预的人报告说，他们的应对和抑郁有所改善。因此，这是第一次审判， 建立住院综合姑息治疗和移植治疗在IM患者中的可行性和初步疗效， 证明恶性血液病患者及其护理者的结局。 研究计划：我们建议进行一项多中心随机试验，对住院患者进行综合姑息治疗和反式治疗。 在接受HCT的恶性血液病患者中，植物护理与单纯移植护理的比较。主 本研究的目的是明确证明住院病人姑息治疗对改善病人和 护理人员报告了一项多中心试验的结局，该试验涉及大量更多样化的患者人群。我们还将 评估姑息治疗干预对参与者报告的QOL和心理结局的影响 HCT后。最后，我们将探讨潜在的调解人和调解人的住院综合姑息和 移植护理模式对患者自报QOL的影响。 环境：本项目将在马萨诸塞州总医院，弗雷德哈钦森癌症康复中心进行。 搜索中心和迈阿密大学。这些网站有姑息治疗和移植经验， 基础设施和流程来进行这项试验。MGH研究团队拥有开发和 测试实体瘤和恶性血液病患者的综合姑息治疗模式，以确保 姑息治疗干预在各研究中心的成功实施和评价。 研究的相关性：该项目将为未来的实施奠定必要的基础， 对接受HCT的患者进行住院综合姑息治疗和移植护理的传播试验。