Status:
RECRUITING
Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Conditions:
Relapsed Adult AML
Primary Refractory Acute Myeloid Leukemia
Eligibility:
All Genders
18-120 years
Phase:
NA
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 outcome...
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 hospita...
Eligibility Criteria
Inclusion
- 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
- \- 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
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
2300 Patients enrolled
Trial Details
Trial ID
NCT05237258
Start Date
June 1 2022
End Date
April 1 2029
Last Update
July 25 2025
Active Locations (20)
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1
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
2
Stanford University
Stanford, California, United States, 94305
3
University of Colorado Denver I Anschutz Medical Campus
Denver, Colorado, United States, 80204
4
University of Miami
Miami, Florida, United States, 33146