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RecruitingInterventional

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

NCT ID: NCT05237258Sponsor: Massachusetts General HospitalLast updated: 2025-07-25

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.

Arms & interventions

  • BehavioralSpecialty 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.

  • BehavioralPrimary 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.

Outcome measures

Primary

  • Quality of Life (QOL)

    Establish that primary palliative care is non-inferior to specialty palliative care in patient-reported quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leukemia) over 12 weeks. Higher scores on FACT-Leukemia (range 0-176) indicate a better QOL.

    Time frame: Over 12 weeks

Secondary

  • Patient Quality of Life (QOL)

    Time frame: Up to 2 Weeks

  • Patient Depression Symptoms

    Time frame: Up to 12 Weeks

  • Patient Anxiety Symptoms

    Time frame: Up to 12 Weeks

  • Patient Post-Traumatic Stress Disorder (PTSD) Symptoms

    Time frame: Up to 12 Weeks

  • End-of-Life (EOL) Communication

    Time frame: Up to 12 Weeks

  • End-of-Life (EOL) Care

    Time frame: Last 30 days of life

  • Caregiver Quality of Life (QOL)

    Time frame: Up to 12 Weeks

  • Caregiver Burden

    Time frame: Up to 12 Weeks

  • Caregiver Depression Symptoms

    Time frame: Up to 12 Weeks

  • Caregiver Anxiety Symptoms

    Time frame: Up to 12 Weeks

Eligibility criteria

Sex: AllAge: 18 Years to 120 YearsHealthy volunteers: Yes
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 locations (20)

University of Alabama - Birmingham

Birmingham, Alabama, 35294

Recruiting
Richard Taylor, PhD · Contact
Omer Jamy, MD · Contact

Stanford University

Stanford, California, 94305

Recruiting
Karl Lorenz, MD · Contact
Gabriel Mannis, MD · Contact

University of Colorado Denver I Anschutz Medical Campus

Denver, Colorado, 80204

Recruiting
Stacy Fischer, MD · Contact
Christine McMahon, MD · Contact

University of Miami

Miami, Florida, 33146

Recruiting
Lara Traeger, PhD · Contact
Michael Huber, MD · Contact

Moffitt Cancer Center

Tampa, Florida, 33612

Recruiting
Sara Tinsley-Vance, PhD · Contact
David Craig, PharmD · Contact

Emory University

Atlanta, Georgia, 30322

Recruiting
Dio Kavalieratos, MD · Contact
Martha Arellano, MD · Contact

Northwestern University

Evanston, Illinois, 60208

Recruiting
Jessica Altman, MD · Contact
Jayson Neagle, MD · Contact

Indiana University

Bloomington, Indiana, 47405

Recruiting
Larry Cripe, MD · Contact
James Cleary, MD · Contact

Johns Hopkins University

Baltimore, Maryland, 21218

Recruiting
Corey Tapper, MD · Contact
B. Douglas Smith, MD · Contact

Massachusetts General Hospital

Boston, Massachusetts, 02115

Recruiting
Areej El-Jawahri, MD · Contact
Areej El-Jawahri, MD · Principal Investigator
Jennifer Temel, MD · Principal Investigator

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting
Oreofe Odejide, MD, MPH · Contact
James Tulsky, MD · Contact

Mayo Clinic

Rochester, Minnesota, 55905

Recruiting
Jacob Strand, MD · Contact
Hassan Alkhateeb, MD · Contact

University of Rochester

Rochester, New York, 14627

Recruiting
Kah Poh Loh, MD · Contact
Paul Vermilion, MD · Contact

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599

Recruiting
Laura Hanson, MD, MPH · Contact
William Wood, Jr., MD · Contact

Duke University

Durham, North Carolina, 27708

Recruiting
Thomas LeBlanc, MD · Contact
Wil Santivasi, MD · Contact

Ohio State University

Columbus, Ohio, 43210

Recruiting
Erin Stevens, DO · Contact
Alice Mims, MD · Contact

Oregon Health & Science University

Portland, Oregon, 97239

Recruiting
Jason Webb, MD · Contact
Rachel Cook, MD, MS · Contact

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Recruiting
Selina Luger, MD · Contact
Kathryn McGrath, MD · Contact

Fred Hutchinson Cancer Center

Seattle, Washington, 98109

Recruiting
Mohamed Sorror, MD, MSc · Contact
James Fausto, PhD · Contact

University of Wisconsin

Madison, Wisconsin, 53715

Recruiting
Priyanka Pophali, MD · Contact
Meaghan Trainor, MD · Contact