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.
We expect that this project will lead to a well-specified, novel palliative and supportive care intervention for people with serious illness such as cancer, the efficacy of which will be tested in a future randomized clinical trial. This study will contribute much-needed knowledge about how to activate patients in cancer treatment to manage symptoms and engage in activities to reduce functional decline leading to better quality of life and greater likelihood of returning home after treatment.
