Actively Recruiting
Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia
Led by Massachusetts General Hospital · Updated on 2025-07-25
2300
Participants Needed
20
Research Sites
52 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying whether primary palliative care provided by trained oncology clinicians is a viable alternative to specialty palliative care teams for improving quality of life, symptoms, mood, coping, and end-of-life outcomes in patients with acute myeloid leukemia (AML). This research focuses on patients newly diagnosed with AML, who face sudden and serious illness requiring urgent hospitalization and chemotherapy. The study aims to determine which care approach better supports patients and their caregivers during this challenging time. Participants will receive either specialty palliative care, involving both oncology and palliative care clinicians during hospital stays, or primary palliative care, where oncology clinicians trained in palliative care provide support. Hospitals are randomly assigned to deliver one of these care strategies, and patients will receive care based on their hospital's assignment. Both approaches aim to address physical symptoms and emotional distress experienced during treatment. Participants will complete baseline self-report assessments at the start of the study and will be monitored over time for quality of life, depression, anxiety, PTSD symptoms, and end-of-life communication and care. Caregivers will also be assessed for quality of life, burden, and mood symptoms. The main outcome measured is the patient's quality of life over 12 weeks. The study includes follow-up during hospitalization and tracks both patient and caregiver experiences to understand the impact of the care models. The trial is sponsored by Massachusetts General Hospital and runs until April 2029.
CONDITIONS
Brief Title
Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hospitalized patients aged 18 years or older with high-risk acute myeloid leukemia (AML)
- Patients with new AML diagnosis aged 60 years or older
- Patients with antecedent hematologic disorder or therapy-related disease
- Patients with relapsed or primary refractory AML
- Within five business days of starting intensive chemotherapy or hypomethylating agents
- Adult caregivers aged 18 years or older who live with or see the patient in person at least twice per week
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia (APML)
- Receiving supportive care alone for AML
- Psychiatric or cognitive conditions preventing informed consent or study compliance
- Seen by a palliative care clinician during two hospitalizations in the past six months
- Expected to be discharged from the hospital within 2 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospital stays for intensive chemotherapy or hypomethylating agents
Participants receive palliative care from either specialty palliative care clinicians or oncology clinicians trained in palliative care during their hospital stays for AML.
Visits occur during hospitalization
Duration - Up to 12 weeks
Participants complete assessments of quality of life, psychological symptoms, and caregiver burden up to 12 weeks after treatment begins.
Regular assessments during this period; frequency may vary
Trial Site Locations
Total: 20 locations
1
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Stanford University
Stanford, California, United States, 94305
Actively Recruiting
3
University of Colorado Denver I Anschutz Medical Campus
Denver, Colorado, United States, 80204
Actively Recruiting
4
University of Miami
Miami, Florida, United States, 33146
Actively Recruiting
5
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
6
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
7
Northwestern University
Evanston, Illinois, United States, 60208
Actively Recruiting
8
Indiana University
Bloomington, Indiana, United States, 47405
Actively Recruiting
9
Johns Hopkins University
Baltimore, Maryland, United States, 21218
Actively Recruiting
10
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
11
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
12
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
13
University of Rochester
Rochester, New York, United States, 14627
Actively Recruiting
14
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
15
Duke University
Durham, North Carolina, United States, 27708
Actively Recruiting
16
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
17
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
18
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
19
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
20
University of Wisconsin
Madison, Wisconsin, United States, 53715
Actively Recruiting
Research Team
A
Areej El-Jawahri, MD
C
Chardria S Trotter, MPH, MBA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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