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: 10456762
• 负责人: Areej El-Jawahri
• 金额: $ 43.84万
• 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/10456762
• 关键词: Address; Anxiety; Caregivers; Caring; Clinical; Communication; Complex; Consult; Data; Deterioration; Diarrhea; Distress; Emotional; Ensure; Environment; Evaluation; Family; Fatigue; Foundations; Friends; Fright; 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; Prognosis; 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; future implementation; implementation trial; improved; improved outcome; intervention effect; loved ones; medical specialties; multi-site trial; 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.

项目概要/摘要 概述：本研究的目的是证明住院姑息治疗与反式治疗相结合的有效性 植物护理可改善血液恶性肿瘤患者的生活质量 (QOL) 和情绪 造血干细胞移植（HCT）及其护理人员。 背景：接受 HCT 的患者在治疗过程中承受着巨大的身体和心理症状负担。 他们接受 3-4 周的移植住院治疗，其中 50-70% 的患者报告中度至重度恶心、疲劳、腹泻、 和疼痛，超过 40% 的人报告有明显的抑郁和焦虑症状。重要的是，患者的生活质量 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）在其亲人的移植期间和移植后也会遭受情绪困扰。德- 尽管这些人承受着沉重的负担，但仍缺乏改善他们的生活质量和护理的干预措施。我们 完成了一项针对非住院患者的住院综合姑息治疗和移植护理的单中心随机试验 进行 HCT 并证明患者的生活质量、症状负担、抑郁症有临床显着改善 HCT 期间的认知和焦虑。值得注意的是，干预措施的效果在干预后持续了三个月和六个月。 HCT 可改善患者的抑郁症和创伤后应激症状。病人的护理人员跑了 接受干预的受访者报告称，他们的应对能力和抑郁症有所改善。因此，这是第一次尝试 建立住院患者综合姑息治疗和移植护理在紧急情况下的可行性和初步疗效 证明血液恶性肿瘤患者及其护理人员的结果。 研究计划：我们建议对住院患者综合姑息治疗和反式治疗进行多中心随机试验 接受 HCT 的血液恶性肿瘤患者的植物护理与单纯移植护理的比较。初级 这项研究的目的是明确证明住院姑息治疗对于改善患者和患者的健康状况的有效性。 护理人员报告了一项针对大量且更加多样化的患者群体的多中心试验的结果。我们还将 评估姑息治疗干预对参与者报告的生活质量和心理结果的影响 HCT 后。最后，我们将探讨住院综合姑息治疗和康复治疗的潜在中介因素和调节因素。 基于患者报告的生活质量的移植护理模型。 环境：该项目将在马萨诸塞州综合医院 Fred Hutchinson Cancer Re- 进行 搜索中心和迈阿密大学。这些站点有姑息治疗和移植经验， 进行该试验的基础设施和流程。 MGH 研究团队拥有开发和 测试实体瘤和血液恶性肿瘤患者的综合姑息治疗模型，以确保 跨研究中心姑息治疗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 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。

项目成果

Protocol for multi-site randomized trial of inpatient palliative care for patients with hematologic malignancies undergoing hematopoietic stem cell transplantation.

对接受造血干细胞移植的血液恶性肿瘤患者进行住院姑息治疗的多中心随机试验方案。

• DOI: 10.1016/j.cct.2024.107460
• 发表时间: 2024
• 期刊: Contemporary clinical trials
• 影响因子: 2.2
• 作者: Yang,Daniel;Newcomb,Richard;Kavanaugh,AlisonR;Khalil,Dania;Greer,JosephA;Chen,Yi-Bin;DeFilipp,Zachariah;Temel,Jennifer;Lee,StephanieJ;LeBlanc,ThomasW;El-Jawahri,Areej
• 通讯作者: El-Jawahri,Areej

Post-Traumatic Stress Symptoms in Hematopoietic Stem Cell Transplant Recipients.

• DOI: 10.1016/j.jtct.2021.01.011
• 发表时间: 2021-04
• 期刊: TRANSPLANTATION AND CELLULAR THERAPY
• 影响因子: 3.2
• 作者: Fenech, Alyssa L.;Van Benschoten, Olivia;Jagielo, Annemarie D.;Ufere, Nneka N.;Topping, Carlisle E. W.;Clay, Madison;Jones, Bailey T.;Traeger, Lara;Temel, Jennifer S.;El-Jawahri, Areej
• 通讯作者: El-Jawahri, Areej

Quality of Life, Physical Functioning, and Psychological Distress of Older Adults Undergoing Hematopoietic Stem Cell Transplantation.

接受造血干细胞移植的老年人的生活质量、身体功能和心理困扰。

• DOI: 10.1016/j.jtct.2023.03.017
• 发表时间: 2023
• 期刊: Transplantation and cellular therapy
• 影响因子: 3.2
• 作者: Newcomb,Richard;Johnson,PConnor;Cronin,Katherine;Choe,JoannaJ;Holmbeck,Katherine;Nabily,Anisa;Lark,Porsha;Rabideau,DustinJ;DeFilipp,Zachariah;Chen,Yi-Bin;El-Jawahri,Areej
• 通讯作者: El-Jawahri,Areej

Association Between Baseline Patient-Reported Outcomes and Complications of Hematopoietic Stem Cell Transplantation.

• DOI: 10.1016/j.jtct.2021.02.029
• 发表时间: 2021-06
• 期刊: TRANSPLANTATION AND CELLULAR THERAPY
• 影响因子: 3.2
• 作者: Johnson, P. Connor;Bhatt, Sunil;Reynolds, Matthew J.;Dhawale, Tejaswini M.;Ufere, Nneka;Jagielo, Annemarie D.;Lavoie, Mitchell W.;Topping, Carlisle E. W.;Clay, Madison A.;Rice, Julia;Yi, Alisha;DeFilipp, Zachariah;Chen, Yi-Bin;El-Jawahri, Areej
• 通讯作者: El-Jawahri, Areej