Recruiting

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

Sponsor:

Massachusetts General Hospital

Code:

NCT05237258

Conditions

Relapsed Adult AML

Primary Refractory Acute Myeloid Leukemia

High Risk Acute Myeloid Leukemia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Specialty Palliative Care

Primary Palliative Care

Study Details

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).

Conditions

Relapsed Adult AML

Primary Refractory Acute Myeloid Leukemia

High Risk Acute Myeloid Leukemia

Study ID

NCT05237258

Start date

Jun 1, 2022

Status verified date

Jul, 2025

Completion date

Apr, 2029

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

2300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Specialty Palliative Care

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

experimental: Primary Palliative Care

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

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.

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.

Primary outcome measure

Quality of Life (QOL) [ Time Frame: Over 12 weeks ]

Central Contacts and Locations

Central contacts

Areej El-Jawahri, MD

617-724-4000 ael-jawahri@partners.org

Chardria S Trotter, MPH, MBA

CTrotter@mgh.harvard.edu

Locations

University of Alabama - Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Richard Taylor, PhD

rtaylor@uabmc.edu

Omer Jamy, MD

omerjamy@uabmc.edu

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Karl Lorenz, MD

kalorenz@stanford.edu

Gabriel Mannis, MD

gmannis@stanford.edu

University of Colorado Denver I Anschutz Medical Campus

Recruiting

Denver, Colorado, United States, 80204

Contacts

Stacy Fischer, MD

STACY.FISCHER@CUANSCHUTZ.EDU

Christine McMahon, MD

CHRISTINE.MCMAHON@CUANSCHUTZ.EDU

University of Miami

Recruiting

Miami, Florida, United States, 33146

Contacts

Lara Traeger, PhD

ltraeger@miami.edu

Michael Huber, MD

mth131@med.miami.edu

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Sara Tinsley-Vance, PhD

Sara.TinsleyVance@moffitt.org

David Craig, PharmD

David.Craig@moffitt.org

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Dio Kavalieratos, MD

d.kavalieratos@emory.edu

Martha Arellano, MD

marella@emory.edu

Northwestern University

Recruiting

Evanston, Illinois, United States, 60208

Contacts

Jessica Altman, MD

jaltman@nm.org

Jayson Neagle, MD

jayson.neagle@nm.org

Indiana University

Recruiting

Bloomington, Indiana, United States, 47405

Contacts

Larry Cripe, MD

lcripe@iu.edu

James Cleary, MD

jfcleary@iu.edu

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21218

Contacts

Corey Tapper, MD

ctapper1@jhmi.edu

B. Douglas Smith, MD

bdsmith@jhmi.edu

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Areej El-Jawahri, MD

617-724-4000 ael-jawahri@mgb.org

Principal Investigator:

Areej El-Jawahri, MD

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Oreofe Odejide, MD, MPH

oreofe_odejide@dfci.harvard.edu

James Tulsky, MD

jamesa_tulsky@dfci.harvard.edu

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Jacob Strand, MD

strand.jacob@mayo.edu

Hassan Alkhateeb, MD

alkhateeb.hassan@mayo.edu

University of Rochester

Recruiting

Rochester, New York, United States, 14627

Contacts

Kah Poh Loh, MD

kahpoh_loh@urmc.rochester.edu

Paul Vermilion, MD

Paul_Vermilion@URMC.Rochester.edu

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Laura Hanson, MD, MPH

laura_hanson@med.unc.edu

William Wood, Jr., MD

william_wood@med.unc.edu

Duke University

Recruiting

Durham, North Carolina, United States, 27708

Contacts

Thomas LeBlanc, MD

Thomas.LeBlanc@duke.edu

Wil Santivasi, MD

wil.santivasi@duke.edu

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Erin Stevens, DO

erin.stevens@osumc.edu

Alice Mims, MD

Alice.Mims@osumc.edu

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Jason Webb, MD

webbja@ohsu.edu

Rachel Cook, MD, MS

coora@ohsu.edu

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Selina Luger, MD

Selina.Luger@Pennmedicine.upenn.edu

Kathryn McGrath, MD

Kathryn.Mcgrath@Pennmedicine.upenn.edu

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Mohamed Sorror, MD, MSc

msorror@fredhutch.org

James Fausto, PhD

jfausto@uw.edu

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53715

Contacts

Priyanka Pophali, MD

pophali@wisc.edu

Meaghan Trainor, MD

mtrainor@medicine.wisc.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jul 25, 2025

Last verified

Jul, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-07-25.