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

N/AActive Not RecruitingNCT03310918

Massachusetts General Hospital320 enrolled

Overview

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) and myelodysplastic syndrome (MDS) receiving non-intensive therapy

Frequently people undergoing treatment for AML or MDS experience physical and emotional symptoms during the course of their illness. These can be very distressing to both patients and their caregivers. Patients with AML or MDS 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 oncology care and standard oncology care with collaborative involvement of palliative care clinicians to see which is better for improving the experience of patients with AML and MDS undergoing treatment. The purpose of this research study is to find out whether introducing patients undergoing treatment for AML or MDS 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

320

Conditions

Acute Myeloid Leukemia Myelodysplastic Syndromes

Interventions

Palliative CareOTHER

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

Standard Leukemia careOTHER

Standard care per the hospital guideline

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Massachusetts General Hospital

Boston, Massachusetts, United States

Ohio State University

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Time from documentation of end-of-life care preferences to death

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

Time frame: up to 2 years

Secondary Outcomes

Rates of documentation of end-of-life care preferences at least one week prior to death.

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

Time frame: up to 2 years

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

comparison of patient-report of discussion end-of-life care preferences between the study arms

Time frame: up to 2 years

Compare Rate of hospitalization between the study arms

Compare rates of hospitalizations within 30 days of death between the study arms

Time frame: up to 30 days

Rate of hospice utilization and length-of-stay in hospice

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

Time frame: up to 2 years

compare quality of life

Compare quality of life (FACT-Leuk) at week-12 and longitudinally between the study arms. Score range 0-176 (higher scores indicating better quality of life)

Time frame: up to six months

compare symptom burden

Compare symptom burden (ESAS) at week-12 and longitudinally between the study arms. the ESAS score range 0-100 with higher scores indicating worse symptom burden.

Data from ClinicalTrials.gov

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