Acute Myeloid Leukemia Clinical Trial

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

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).

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Full 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.

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Eligibility Criteria

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
Receiving treatment 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 or APP] during two previous hospitalizations in the six months prior to enrollment

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

2300

Study ID:

NCT05237258

Recruitment Status:

Recruiting

Sponsor:

Massachusetts General Hospital

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There are 20 Locations for this study

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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 More Info
Dio Kavalieratos, MD
Contact
[email protected]
Martha Arellano, MD
Contact
[email protected]
Northwestern University
Evanston Illinois, 60208, United States
Indiana University
Bloomington Indiana, 47405, United States More Info
Larry Cripe, MD
Contact
[email protected]
James Cleary, MD
Contact
[email protected]
Johns Hopkins University
Baltimore Maryland, 21218, United States More Info
Corey Tapper, MD
Contact
[email protected]
B. Douglas Smith, MD
Contact
[email protected]
Massachusetts General Hospital
Boston Massachusetts, 02115, United States More Info
Areej El-Jawahri, MD
Contact
617-724-4000
[email protected]
Areej El-Jawahri, MD
Principal Investigator
Jennifer Temel, MD
Principal Investigator
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Oreofe Odejide, MD, MPH
Contact
[email protected]
James Tulsky, MD
Contact
[email protected]
Mayo Clinic
Rochester Minnesota, 55905, United States More Info
Mark Litzow, MD
Contact
[email protected]
Jacob Strand, MD
Contact
[email protected]
University of Rochester
Rochester New York, 14627, United States
University of North Carolina at Chapel Hill
Chapel Hill North Carolina, 27599, United States More Info
Laura Hanson, MD, MPH
Contact
[email protected]
William Wood, Jr., MD
Contact
[email protected]
Duke University
Durham North Carolina, 27708, United States More Info
Thomas LeBlanc, MD
Contact
[email protected]
Wil Santivasi, MD
Contact
[email protected]
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 More Info
Selina Luger, MD
Contact
[email protected]
Kathryn McGrath, MD
Contact
[email protected]
Fred Hutchinson Cancer Center
Seattle Washington, 98109, United States
University of Wisconsin
Madison Wisconsin, 53715, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

2300

Study ID:

NCT05237258

Recruitment Status:

Recruiting

Sponsor:


Massachusetts General Hospital

How clear is this clinincal trial information?

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