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

针对新诊断的急性髓系白血病成人的护士主导的姑息和支持护理干预措施

• 批准号: 10216694
• 负责人: Ashley Leak Bryant
• 金额: $ 19.44万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-03-09 至 2023-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10216694
• 关键词: Acute Myelocytic Leukemia; Address; Adult; Adverse event; Affect; Aftercare; Age-Years; Ambulatory Care Facilities; Anxiety; Caregivers; Caring; Chronic; Chronic Disease; Clinical; Clinical Practice Guideline; Cognition; Data; Data Collection; Deterioration; Development; Diagnosis; Discipline of Nursing; Disease; Elderly; Emotional; Enrollment; Fatigue; Foundations; Freedom; Future; Goals; Hematologic Neoplasms; Home; Hospitalization; Hospitals; Hour; Independent Living; Infection; Infrastructure; Infusion procedures; Institutional Review Boards; Intervention; Intervention Studies; Interview; Knowledge; Leadership; Length of Stay; Life; Malignant Neoplasms; Manuals; Measures; Methods; Modeling; Monitor; Motivation; Movement; Newly Diagnosed; Nurses; Occupational Therapy; Oncology; Oral; Outcome; Outpatients; Pain; Palliative Care; Patient Self-Report; Patients; Physical therapy; Prevention; Prize; Procedures; Prognosis; Protocols documentation; Quality of life; Randomized Clinical Trials; Randomized Controlled Trials; Readiness; Recommendation; Regimen; Registered nurse; Reporting; Self Management; Site; Sleep disturbances; Specific qualifier value; Supportive care; Surveys; Symptoms; Test Result; Testing; Therapeutic Intervention; Time; Training; Treatment Efficacy; Walking; Work; Workload; Writing; acceptability and feasibility; acute care; base; cancer therapy; chemotherapy; collaborative care; daily functioning; data management; depressive symptoms; design; efficacy trial; end of life; exercise intervention; experience; functional decline; health care service utilization; high risk; hospital readmission; improved; improved functioning; leukemia treatment; medical specialties; mortality risk; novel; nursing intervention; operation; psychologic; recruit; reduce symptoms; retention rate; skills; social; standard care; symptom management; symptom self management; treatment duration

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.

7. 项目概要/摘要 急性髓系白血病 (AML) 是老年人（> 60 岁）的一种严重疾病，具有很高的死亡风险和 超过三分之二的患者不会对日常功能和生活质量（QOL）产生负面影响； 最近，除了输注低甲基化药物外，口服维奈托克 (VEN) 已获批准。 （HMA）大大提高了老年人的治疗效果，现在的方案通常是接受 第一个周期在医院进行 7 天的治疗，然后回家进行 21 天的治疗 护理人员更积极地参与，患者疲劳的风险很高，这会导致功能下降和 随后生活质量（QOL）下降，妨碍他们恢复独立生活。 使用姑息治疗和协作治疗在 AML 治疗早期解决症状和功能管理 由接受过姑息治疗和支持性护理基础培训的临床工作人员提供护理干预 (PACT) 弥合护理方面的差距并解决患者的生活质量问题。 因此，PACT 的目标是症状管理和预防。 PACT 是一种由护士主导的跨学科机制。 对 60 岁以上成人进行护理干预 [RN]、职业治疗 [OT]、物理治疗 [PT] 在慢性病适应性领导框架的指导下，在入院后两天内开始， PACT 团队与患者合作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 QOL 结果（即症状、功能领域）。 具有自我管理技能，以减轻严重疾病期间的症状并优化功能。 团队和患者识别并解决情感、动机、态度障碍，以便患者能够做到 自我管理所需的工作是减少症状并避免功能衰退。 评估生活质量、症状、功能和生活质量前后测量的可行性、可接受性和变化 HMA + VEN 方案的 2 个周期（总共 60 天）为出院做好准备 我们提出了一个两年计划。 项目的目标如下： 1) 确定研究方法的可行性和可接受性，并检查研究方法的变化 治疗前和治疗后的功能测量、患者自我报告的症状和生活质量以及患者和 护理人员关于出院准备情况的自我报告将包括 10 名对照患者和 10 名干预患者， 2) 根据从目标 1 中学到的知识制定和编写 R01 提案。最终确定方案，建立研究 基础设施，包括扩大跨学科团队；确定和注册 R01 站点，完善招聘 战略和运营程序、程序手册以及质量和数据管理计划并获取； IRB 批准随机对照试验 (RCT) R01 我们致力于解决 NINR 的临终关怀和姑息治疗问题。 优先事项。