A Collaborative Palliative and Leukemia Care Model for Patients With AML Receiving Non-Intensive Therapy

A Collaborative Palliative and Leukemia Care Model for Patients With AML Receiving Non-Intensive Therapy

Randomized Trial of a Collaborative Palliative and Leukemia Care Model for Patients With Acute Myeloid Leukemia Receiving Non-Intensive Therapy

This research study is evaluating the impact a collaborative palliative care and oncology team will have on end-of-life outcomes, quality of end-of-life care, and the quality of life, symptoms, and mood of patients with acute myeloid leukemia (AML) receiving non-intensive therapy

Frequently people undergoing leukemia treatment experience physical and emotional symptoms during the course of their illness. These can be very distressing to both patients and their caregivers. Patients with acute leukemia receiving non-intensive therapy also often experience a rapid decline in their health status and have a limited prognosis. Despite their limited life-expectancy, they rarely engage in discussion with their clinicians regarding their goals and preferences for care at the end of life. The study doctors want to know if the early introduction of a team of clinicians that specialize in the lessening (palliation) of many of these distressing symptoms and have expertise in enhancing communication about prognosis and illness trajectory may improve the overall care of patients with acute leukemia. This team of clinicians is called the palliative care team and they focus on ways to improve the participant's pain and other symptom management (nausea, fatigue, shortness of breath, anxiety, etc.) and to assist the participant and the participant's caregivers in coping with the emotional and social issues associated with their diagnosis. The team consists of physicians and advance practice nurses who have been specially trained in the care of patients facing serious illness. The main purpose of this study is to compare two types of care - standard leukemia oncology care and standard leukemia oncology care with collaborative involvement of palliative care clinicians to see which is better for improving the experience of patients with acute myeloid leukemia (AML) undergoing treatment. The purpose of this research study is to find out whether introducing patients undergoing treatment for acute myeloid leukemia to the palliative care team can improve their end-of-life communication, understanding of their prognosis, and their physical and psychological symptoms during the course of their illness.

1st palliative care visit within 96 hours of randomization in the outpatient or hospital In outpatient setting: At least once weekly for the first 30 days and then at least twice per month thereafter palliative care clinic visits or contact via telephone During hospital admissions to MGH: At least twice weekly palliative care visits

Specialized medical care for people with serious illness. This type of care is focused on providing relief from the symptoms and stress of a serious illness. The goal is to improve quality of life for both the patient and the family

comparison of time from documentation of end-of-life care preferences to death in the electronic health records

Comparison of the rate of documentation of end-of-life care preferences at least one week prior to death in the electronic health record

Patient-report of discussing end-of-life care preferences based on an item from the perception of treatment and prognosis questionnaire

Compare rates of hospice utilization and length-of-stay in hospice at the end of life between the study arms

Compare change in quality of life (FACT-Leuk) from baseline to week-2, week-4, and longitudinally between the study arms

Compare change in symptom burden (ESAS) from baseline to week-2, week-4, and longitudinally between the study arms

Compare change in mood (HADS) from baseline to week-2, week-4, and longitudinally between the study arms

compare rate of chemotherapy administration within 3, 7, 14, and 30 days of death between the two study arms

caregiver-reported discussion of end-of-life care preferences as measured by the perception of treatment and prognosis questionnaire

compare caregiver-reported discussion of end-of-life care preferences between the study arms at one month

Inclusion Criteria: Patients with AML receiving non-intensive therapy including hypomethylating agents, single-agent chemotherapy, targeted therapy agents, or single or combination non-intensive agents offered on a clinical trial, including the following populations: Newly diagnosed AML Relapsed AML Primary refractory AML The ability to provide informed consent The ability to comprehend English or complete questionnaires with minimal assistance of an interpreter Exclusion Criteria: Patients not receiving care at MGH Patients receiving intensive chemotherapy (requiring 4-6 week hospitalization) Patients receiving supportive care alone Major psychiatric illness or co-morbid conditions prohibiting compliance with study procedures Patients already receiving palliative care