RecruitingRecruiting
Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia
NCT05237258 · Massachusetts General Hospital
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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.
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
* 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 target: 2300 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-06-01
Estimated completion: 2029-04
Last updated: 2025-07-25
Interventions
Behavioral: Specialty Palliative CareBehavioral: Primary Palliative Care
Primary outcomes
- • Quality of Life (QOL) (Over 12 weeks)
Sponsor
Massachusetts General Hospital · other
With: Patient-Centered Outcomes Research Institute
Contacts & investigators
ContactAreej El-Jawahri, MD · contact · ael-jawahri@partners.org · 617-724-4000
ContactChardria S Trotter, MPH, MBA · contact · CTrotter@mgh.harvard.edu
InvestigatorAreej El-Jawahri, MD · principal_investigator, Massachusetts General Hospital
InvestigatorJennifer Temel, MD · principal_investigator, Massachusetts General Hospital
All locations (20)
University of Alabama - BirminghamRecruiting
Birmingham, Alabama, United States
Stanford UniversityRecruiting
Stanford, California, United States
University of Colorado Denver I Anschutz Medical CampusRecruiting
Denver, Colorado, United States
University of MiamiRecruiting
Miami, Florida, United States
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
Emory UniversityRecruiting
Atlanta, Georgia, United States
Northwestern UniversityRecruiting
Evanston, Illinois, United States
Indiana UniversityRecruiting
Bloomington, Indiana, United States
Johns Hopkins UniversityRecruiting
Baltimore, Maryland, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Mayo ClinicRecruiting
Rochester, Minnesota, United States
University of RochesterRecruiting
Rochester, New York, United States
University of North Carolina at Chapel HillRecruiting
Chapel Hill, North Carolina, United States
Duke UniversityRecruiting
Durham, North Carolina, United States
Ohio State UniversityRecruiting
Columbus, Ohio, United States
Oregon Health & Science UniversityRecruiting
Portland, Oregon, United States
University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
Fred Hutchinson Cancer CenterRecruiting
Seattle, Washington, United States
University of WisconsinRecruiting
Madison, Wisconsin, United States