Protocol for multi-site randomized trial of inpatient palliative care for patients with hematologic malignancies undergoing hematopoietic stem cell transplantation.
Protocol for multi-site randomized trial of inpatient palliative care for patients with hematologic malignancies undergoing hematopoietic stem cell transplantation.
复制标题
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
复制
发表时间：
2024
影响因子：
2.2
通讯作者：
El-Jawahri,Areej
中科院分区：
文献类型：
--
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
背景接受造血干细胞移植（HSCT）的恶性血液病患者通常在3-4周的住院期间经历衰弱的身体和心理症状。在住院期间，护理人员（即，家人和朋友）在目睹亲人与HSCT毒性作斗争时也承受着巨大的情绪压力。然而，干预措施，以提高生活质量（QOL），减少心理困扰HSCT是limited.MethodsWe正在进行一项多站点的随机对照试验，住院综合姑息治疗和移植护理与常规护理在360例HSCT住院患者和他们的照顾者在三个学术中心。干预参与者在HSCT住院期间每周至少两次与姑息治疗临床医生会面，以解决他们的身体和心理症状。分配到常规护理的患者接受HSCT团队提供的所有支持性护理措施，并可根据要求接受姑息治疗。我们评估患者的生活质量（癌症治疗功能评估（FACT）-骨髓移植），抑郁和焦虑症状（医院焦虑和抑郁量表），创伤后应激障碍（PTSD）症状在基线、HSCT后2周、3个月、6个月和12个月时，评估PTSD（PTSD检查表）、症状负担（埃德蒙顿症状评估量表）和疲劳（FACT-疲劳）以及患者报告的结局。主要终点是比较两组患者在HSCT住院期间第2周的生活质量，当患者通常在HSCT.ConclusionsThis多中心试验期间经历他们的生活质量最低点时，将定义姑息治疗的作用，以改善生活质量和护理接受HSCT的血液恶性肿瘤患者及其护理人员。
BackgroundPatients with hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT) commonly experience debilitating physical and psychological symptoms during a 3–4-week-hospitalization. During hospitalization, caregivers (i.e., family and friends) also endure immense emotional stress as they witness their loved one struggle with HSCT toxicities. Yet interventions to improve quality of life (QOL) and reduce psychological distress during HSCT are limited.MethodsWe are conducting a multi-site randomized controlled trial of inpatient integrated palliative and transplant care versus usual care in 360 patients hospitalized for HSCT and their caregivers at three academic centers. Intervention participants meet with a palliative care clinician at least twice weekly during the HSCT hospitalization to address their physical and psychological symptoms. Patients assigned to usual care receive all supportive care measures provided by the HSCT team and could be seen by palliative care upon request. We assess patient QOL (Functional Assessment of Cancer Therapy (FACT) - Bone Marrow Transplant), depression and anxiety symptoms (Hospital Anxiety and Depression Scale), post-traumatic stress (PTSD) symptoms (PTSD checklist), symptom burden (Edmonton Symptom Assessment Scale), and fatigue (FACT-Fatigue) as well as caregiver-reported outcomes at baseline, 2 weeks, 3-months, 6-months, and 12-months post-HSCT. The primary endpoint is to compare QOL at week-2 during HSCT hospitalization between the two groups when patients typically experience their QOL nadir during HSCT.ConclusionsThis multi-site trial will define the role of palliative care for improving QOL and care for patients with hematologic malignancies undergoing HSCT and their caregivers.