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

NCT ID: NCT05237258

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2029-04-30

Brief 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.

Conditions

Relapsed Adult AML; Primary Refractory Acute Myeloid Leukemia; High Risk Acute Myeloid Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Specialty Palliative Care

\- Participants will complete baseline self-report assessments at the time of informed consent

Group Type: EXPERIMENTAL

Specialty Palliative Care

Intervention Type: BEHAVIORAL

Participants assigned to specialty palliative care will be cared for by both oncology and palliative care clinicians during their hospital stays for AML.

Primary Palliative Care

\- Participants will complete baseline self-report assessments at the time of informed consent

Group Type: EXPERIMENTAL

Primary Palliative Care

Intervention Type: BEHAVIORAL

Participants assigned primary palliative care will be cared for by oncology clinicians who have been trained in palliative care during the hospital stays for AML.

Interventions

Specialty Palliative Care

Participants assigned to specialty palliative care will be cared for by both oncology and palliative care clinicians during their hospital stays for AML.

Intervention Type: BEHAVIORAL

Primary Palliative Care

Participants assigned primary palliative care will be cared for by oncology clinicians who have been trained in palliative care during the hospital stays for AML.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

El-Jawahri, Areej,M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Areej El-Jawahri, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Jennifer Temel, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

University of Alabama - Birmingham

Birmingham, Alabama, United States

Site Status: RECRUITING

Stanford University

Stanford, California, United States

Site Status: RECRUITING

University of Colorado Denver I Anschutz Medical Campus

Denver, Colorado, United States

Site Status: RECRUITING

University of Miami

Miami, Florida, United States

Site Status: RECRUITING

Moffitt Cancer Center

Tampa, Florida, United States

Site Status: RECRUITING

Emory University

Atlanta, Georgia, United States

Site Status: RECRUITING

Northwestern University

Evanston, Illinois, United States

Site Status: RECRUITING

Indiana University

Bloomington, Indiana, United States

Site Status: RECRUITING

Johns Hopkins University

Baltimore, Maryland, United States

Site Status: RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status: RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

Site Status: RECRUITING

University of Rochester

Rochester, New York, United States

Site Status: RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status: RECRUITING

Duke University

Durham, North Carolina, United States

Site Status: RECRUITING

Ohio State University

Columbus, Ohio, United States

Site Status: RECRUITING

Oregon Health & Science University

Portland, Oregon, United States

Site Status: RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Site Status: RECRUITING

University of Wisconsin

Madison, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Areej El-Jawahri, MD

Role: CONTACT

ael-jawahri@partners.org

617-724-4000

Chardria S Trotter, MPH, MBA

Role: CONTACT

CTrotter@mgh.harvard.edu

Facility Contacts

Richard Taylor, PhD

Role: primary

rtaylor@uabmc.edu

Omer Jamy, MD

Role: backup

omerjamy@uabmc.edu

Karl Lorenz, MD

Role: primary

kalorenz@stanford.edu

Gabriel Mannis, MD

Role: backup

gmannis@stanford.edu

Stacy Fischer, MD

Role: primary

STACY.FISCHER@CUANSCHUTZ.EDU

Christine McMahon, MD

Role: backup

CHRISTINE.MCMAHON@CUANSCHUTZ.EDU

Lara Traeger, PhD

Role: primary

ltraeger@miami.edu

Michael Huber, MD

Role: backup

mth131@med.miami.edu

Sara Tinsley-Vance, PhD

Role: primary

Sara.TinsleyVance@moffitt.org

David Craig, PharmD

Role: backup

David.Craig@moffitt.org

Dio Kavalieratos, MD

Role: primary

d.kavalieratos@emory.edu

Martha Arellano, MD

Role: backup

marella@emory.edu

Jessica Altman, MD

Role: primary

jaltman@nm.org

Jayson Neagle, MD

Role: backup

jayson.neagle@nm.org

Larry Cripe, MD

Role: primary

lcripe@iu.edu

James Cleary, MD

Role: backup

jfcleary@iu.edu

Corey Tapper, MD

Role: primary

ctapper1@jhmi.edu

B. Douglas Smith, MD

Role: backup

bdsmith@jhmi.edu

Areej El-Jawahri, MD

Role: primary

ael-jawahri@mgb.org

617-724-4000

Oreofe Odejide, MD, MPH

Role: primary

oreofe_odejide@dfci.harvard.edu

James Tulsky, MD

Role: backup

jamesa_tulsky@dfci.harvard.edu

Jacob Strand, MD

Role: primary

strand.jacob@mayo.edu

Hassan Alkhateeb, MD

Role: backup

alkhateeb.hassan@mayo.edu

Kah Poh Loh, MD

Role: primary

kahpoh_loh@urmc.rochester.edu

Paul Vermilion, MD

Role: backup

Paul_Vermilion@URMC.Rochester.edu

Laura Hanson, MD, MPH

Role: primary

laura_hanson@med.unc.edu

William Wood, Jr., MD

Role: backup

william_wood@med.unc.edu

Thomas LeBlanc, MD

Role: primary

Thomas.LeBlanc@duke.edu

Wil Santivasi, MD

Role: backup

wil.santivasi@duke.edu

Erin Stevens, DO

Role: primary

erin.stevens@osumc.edu

Alice Mims, MD

Role: backup

Alice.Mims@osumc.edu

Jason Webb, MD

Role: primary

webbja@ohsu.edu

Rachel Cook, MD, MS

Role: backup

coora@ohsu.edu

Selina Luger, MD

Role: primary

Selina.Luger@Pennmedicine.upenn.edu

Kathryn McGrath, MD

Role: backup

Kathryn.Mcgrath@Pennmedicine.upenn.edu

Mohamed Sorror, MD, MSc

Role: primary

msorror@fredhutch.org

James Fausto, PhD

Role: backup

jfausto@uw.edu

Priyanka Pophali, MD

Role: primary

pophali@wisc.edu

Meaghan Trainor, MD

Role: backup

mtrainor@medicine.wisc.edu

Other Identifiers

21-646

Identifier Type: -

Identifier Source: org_study_id