Comparing two types of palliative care for patients with acute myeloid leukemia
Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia
This study is testing if regular palliative care can help hospitalized patients with acute myeloid leukemia feel better and cope with their illness just as well as specialty palliative care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2300 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 20 sites (Birmingham, Alabama and 19 other locations) |
| Trial ID | NCT05237258 on ClinicalTrials.gov |
What this trial studies
This research evaluates whether primary palliative care can serve as an effective alternative to specialty palliative care for patients with acute myeloid leukemia (AML). The study focuses on hospitalized patients who are experiencing significant physical and emotional distress due to their diagnosis and treatment. It aims to improve quality of life, symptoms, mood, coping, and end-of-life outcomes by comparing the two approaches to palliative care. The involvement of caregivers is also considered, as they play a crucial role in the patient's experience during this challenging time.
Who should consider this trial
Good fit: Ideal candidates include hospitalized adults aged 18 and older with high-risk AML or those who are relapsed or primary refractory.
Not a fit: Patients with acute promyelocytic leukemia or those receiving only supportive care may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of life and emotional well-being of patients with acute myeloid leukemia.
How similar studies have performed: Previous studies have shown that both specialty and primary palliative care approaches can improve patient outcomes, indicating that this study builds on established findings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama and 19 other locations
- University of Alabama - Birmingham — Birmingham, Alabama, United States (Recruiting)
- Stanford University — Stanford, California, United States (Recruiting)
- University of Colorado Denver I Anschutz Medical Campus — Denver, Colorado, United States (Recruiting)
- University of Miami — Miami, Florida, United States (Recruiting)
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
- Emory University — Atlanta, Georgia, United States (Recruiting)
- Northwestern University — Evanston, Illinois, United States (Recruiting)
- Indiana University — Bloomington, Indiana, United States (Recruiting)
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- University of Rochester — Rochester, New York, United States (Recruiting)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
- Ohio State University — Columbus, Ohio, United States (Recruiting)
- Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Fred Hutchinson Cancer Center — Seattle, Washington, United States (Recruiting)
- University of Wisconsin — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Areej El-Jawahri, MD — Massachusetts General Hospital
- Study coordinator: Areej El-Jawahri, MD
- Email: ael-jawahri@partners.org
- Phone: 617-724-4000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.