Specialty Compared to Oncology Delivered Palliative Care for Patients with Acute Myeloid Leukemia - SCOPELeukemia

Primary Objective

This is a cluster randomized comparative effectiveness trial of primary palliative care (PC) versus specialty PC in 1150 patients with acute myeloid leukemia (AML) and their caregivers. The primary objective is to determine whether primary PC is non-inferior to specialty PC for improving quality of life (QOL) in patients with AML. The primary hypothesis is that patients assigned to primary PC will report QOL that is non-inferior to patients receiving specialty PC, with a non-inferiority margin of 5.0 points.

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Description

This is a cluster randomized comparative effectiveness trial of primary palliative care (PC) versus specialty PC in 1150 patients with acute myeloid leukemia (AML) and their caregivers.

Details
Age

Adult

Eligibility

Hospitalized patients with high-risk Acute Myeloid Leukemia who are receiving either intensive chemotherapy or hypomethylating agents1) Hospitalized patients (age > 18 years) with high-risk AML defined as one of the following: - Patients with new diagnosis > 60 years of age - An antecedent hematologic disorder - Therapy related-disease - Relapsed or primary refractory AML 2) Receiving treatment 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

Locations

University of Colorado Hospital

Principal Investigator
Photograph of STACY FISCHER

STACY FISCHER

Study ID

Protocol Number: 23-2210

More information available at ClinicalTrials.gov: NCT05237258

Categories

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