A Nurse-Led Palliative and Supportive Care Intervention for Newly Diagnosed Adults with Acute Myeloid Leukemia

7.项目摘要/摘要 急性髓系白血病(AML)是老年人的一种严重疾病，具有很高的死亡率和 对日常功能和生活质量(QOL)产生负面影响。预后不佳；超过三分之二的患者不会 存活5年。最近，口服维奈替克(VEN)除了输注去甲基化药物外，还被批准 (HMAS)大大提高了老年人的治疗效果，现在的方案通常是 第一个周期在医院治疗7天，然后回国治疗21天 照顾者更积极地参与。患者有很高的疲劳风险，这会导致功能衰退和 随后，他们的生活质量(QOL)下降，干扰他们恢复独立生活。我们建议 在急性髓细胞白血病治疗的早期使用姑息性和协作性治疗解决症状和功能管理 接受姑息和支持性护理基本培训的临床工作人员提供的护理干预(PACT) 在护理和解决生活质量方面弥合这一差距。患者高度珍视摆脱症状和活动能力的自由 关于生活质量的重要方面。因此，PACT的目标是症状管理和预防 作为支持生活质量的机制，功能衰退。派克是一个由护士领导的跨学科组织 护理[RN]、作业疗法[OT]、物理疗法[PT]对60岁至≥成人的干预 在入院后两天内开始。在慢性病适应性领导框架的指导下， PACT团队与患者一起评估和管理他们的症状(例如焦虑、抑郁 症状、疼痛、疲劳、睡眠障碍、认知)，并优化功能(例如，术后活动测量 急性护理、功能)，以解决生活质量结果(即症状、功能域)。PACT赋予患者权力 具有自我管理能力，能够在这段大病期间减轻症状，优化功能。这个 团队和患者识别并解决情绪、动机和态度障碍，以便患者能够 自我管理所需的工作，以减少症状和避免功能衰退。我们的主要目标是 评估生活质量、症状、功能和治疗前后测量的可行性、可接受性和变化。 HMA+VEN方案2个周期(共60天)准备出院。我们提出了一项为期两年的计划 具有这些目标的项目：1)确定研究方法的可行性和可接受性，并审查 治疗前后的功能评定、患者症状自评及生活质量评定。 照顾者发布的准备出院的自我报告。我们将包括10名对照组和10名干预患者， 2)根据从目标1学到的内容，开发并编写R01提案。最终确定协议，建立研究 基础设施，包括扩大跨学科团队；确定并招募R01站点，完善招聘 战略和操作程序、程序手册以及质量和数据管理计划；并获得 IRB批准随机对照试验(RCT)R01。我们致力于NINR的临终关怀和姑息治疗 优先事项。

7. PROJECT SUMMARY/ABSTRACT Acute myeloid leukemia (AML) is a serious illness of older adults (>60) which carries a high risk of mortality and negatively impacts daily function and quality of life (QOL). Prognosis is poor; over two-thirds of patients will not survive 5 years. Recently, approval of oral venetoclax (VEN) in addition to infusional hypomethylating agents (HMAs) has improved treatment efficacy substantially for older adults, and protocols now typically are to receive the first cycle of treatment during 7 days in the hospital and then return home for 21 days of treatment with caregivers more actively involved. Patients are at high risk for fatigue, which leads to functional decline and subsequent deterioration in quality of life (QOL), interfering with their return to independent living. We propose to address symptoms and function management early in AML treatment using a PAlliative and Collaborative Care inTervention (PACT) delivered by clinical staff who receive basic training in palliative and supportive care to bridge this gap in care and address QOL. Patients highly prize freedom from symptoms and ability to move about as important aspects of QOL. Accordingly, PACT targets symptom management and prevention of functional decline as mechanisms through which QOL is supported. PACT is an interdisciplinary nurse-led intervention of nursing [RN], occupational therapy [OT], physical therapy [PT] for adults ≥ 60 years of age to begin within two days of hospital admission. Guided by the Adaptive Leadership Framework for Chronic Illness, the PACT team works with the patient to assess and manage their symptoms (e.g. anxiety, depressive symptoms, pain, fatigue, sleep disturbance, cognition) and to optimize function (e.g Activity Measure for Post- Acute Care, function) to address QOL outcomes (i.e. symptoms, function domains). PACT empowers patients with self-management skills to reduce symptoms and optimize function during this period of serious illness. The team and patient identify and address emotional, motivational, attitudinal barriers so that the patient can do the work required for self- management to reduce symptoms and avoid functional decline. Our primary objective is to assess feasibility, acceptability, and change in pre and post measures of QOL, symptoms, function, and readiness for discharge in 2 cycles (total of 60 days) of HMA + VEN regimen. We propose a two-year planning project with these aims: 1) Determine feasibility and acceptability of study methods and examine changes in pre- and post- treatment measures of function, patients' self-report of symptoms and QOL, and patients and caregivers' post self-report of readiness for discharge. We will include 10 control and 10 intervention patients, and 2) Develop and write R01 proposal based on what is learned from Aim 1. Finalize protocol, establish study infrastructure including expanding interdisciplinary team; identify and enroll R01 sites, refine recruitment strategy and operations procedures, procedures manual, and quality and data management plan; and obtain IRB approval for the randomized controlled trial (RCT) R01. We address NINR's End-of-Life and Palliative Care priorities.