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NCT05237258NARecruitingAccepts Healthy Volunteers

Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia

Massachusetts General Hospital

Start Date

6/1/2022

Completion Date

4/1/2029

Summary

This research study is evaluating whether primary palliative care is an alternative strategy to specialty palliative care for improving quality of life, symptoms, mood, coping, and end of life outcomes in patients with acute myeloid leukemia (AML).

Detailed Description

Patients with newly diagnosed AML confront a sudden and life-threatening diagnosis, requiring an immediate disruption of their life and an urgent hospitalization to begin therapy. During their hospitalization for chemotherapy, patients with AML often experience difficult physical symptoms that negatively impact their quality of life and physical function. Patients with AML also experience significant psychological distress as they combat the abrupt onset of illness, uncertainty regarding their prognosis, physical and social isolation during hospitalization, and complete loss of independence. The abrupt onset of these symptoms can be distressing to both the patient and their family and friends (also called "caregivers"). Research has shown that early involvement of a team of clinicians specializing in lessening (or "palliating") these physical and emotional symptoms and helping patients and their caregivers cope with AML improves their quality of life and experience with their illness. This team is called "specialty palliative care" and consists of physicians and advanced practice providers who work closely and collaboratively with the oncology team to care for patients and caregivers. Research has also shown that training oncology clinicians to incorporate palliative care skills into their practice, called "primary palliative care," is an alternative strategy to having specialty palliative care clinicians care for patients with leukemia. The purpose of this study is to determine whether specialty palliative care or primary palliative care is the best way to improve the quality of life and experience of patients with AML and their caregivers. This study will randomly assign hospitals to deliver either specialty palliative care or primary palliative care for patients with AML. Participants in this study will receive either specialty or primary palliative care during their hospital stays based upon which strategy their hospital has been assigned to. Participants assigned to specialty palliative care will be care for by both oncology and palliative care clinicians during their hospital stays for AML. Participants assigned to primary palliative care will be cared for by oncology clinicians who have been trained in palliative care during their hospital stays for AML.

Eligibility Criteria

Age Range: 18 years to 120 years

Inclusion Criteria: * Patient Inclusion Criteria * Hospitalized patients (age ≥ 18 years) with high-risk AML defined as: * Patients with new diagnosis ≥ 60 years of age * An antecedent hematologic disorder * Therapy related-disease * Relapsed or primary refractory AML * Within five business days of initiating therapy with either a) intensive chemotherapy (7+3) or modification of this regimen on a clinical trial, or a similar intensive regimen requiring prolonged hospitalization; or b) hypomethylating agents +/- additional agents or modification of this regimen on a clinical trial. * Caregiver Inclusion Criteria * Adult (≥18 years) relative or friend of a participating patient who the patient identifies as living with or has in-person contact with them at least twice per week. Exclusion Criteria: \- Patient Exclusion Criteria * Patients with a diagnosis of acute promyelocytic leukemia (APML) * Patients with AML receiving supportive care alone * Patients with psychiatric or cognitive conditions which the treating clinicians believe prohibits informed consent or compliance with study procedures * Patients seen by a palliative care clinician (MD, DO, APP) during two previous hospitalizations in the six months prior to enrollment * Patients expected to be discharged within 2 days

Interventions

BEHAVIORAL

Specialty Palliative Care

BEHAVIORAL

Primary Palliative Care

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Conditions

Relapsed Adult AMLPrimary Refractory Acute Myeloid LeukemiaHigh Risk Acute Myeloid Leukemia

Locations

University of Alabama - Birmingham

Birmingham, Alabama 35294

United States

Stanford University

Stanford, California 94305

United States

University of Colorado Denver I Anschutz Medical Campus

Denver, Colorado 80204

United States

University of Miami

Miami, Florida 33146

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Emory University

Atlanta, Georgia 30322

United States

Northwestern University

Evanston, Illinois 60208

United States

Indiana University

Bloomington, Indiana 47405

United States

Johns Hopkins University

Baltimore, Maryland 21218

United States

Massachusetts General Hospital

Boston, Massachusetts 02115

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

University of Rochester

Rochester, New York 14627

United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27599

United States

Duke University

Durham, North Carolina 27708

United States

Ohio State University

Columbus, Ohio 43210

United States

Oregon Health & Science University

Portland, Oregon 97239

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Fred Hutchinson Cancer Center

Seattle, Washington 98109

United States

University of Wisconsin

Madison, Wisconsin 53715

United States