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

Palliative Care Approaches for Acute Myeloid Leukemia

L
Larry Cripe, MD

Primary Investigator

Recruiting
18 years - 100 years
All
Phase N/A
50 participants needed
1 Location

Brief description of study

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 outcomes in patients with acute myeloid leukemia (AML).

Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

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 of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Acute myeloid leukemia, AML, Cancer
  • Age: 18 years - 100 years
  • Gender: All

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

This study investigates the impact of different palliative care strategies on patients with acute myeloid leukemia (AML). Acute myeloid leukemia is a type of cancer that affects the blood and bone marrow. It is characterized by the rapid growth of abnormal white blood cells that accumulate in the bone marrow and interfere with the production of normal blood cells. The purpose of this study is to compare primary palliative care, where oncology clinicians trained in palliative care provide support, with specialty palliative care, where both oncology and dedicated palliative care clinicians are involved, to see which approach better improves quality of life and other outcomes for patients.

Participants in this study will be randomly assigned to receive either primary or specialty palliative care during their hospital stays. Those receiving specialty palliative care will have a team that includes both oncology and palliative care specialists, while those in the primary palliative care arm will be cared for by oncology clinicians trained in palliative care. This study aims to assess various outcomes, including quality of life, symptoms, mood, coping, and end-of-life experiences for patients with AML.

  • Who can participate: Adults 18 and over hospitalized with high-risk AML, including those newly diagnosed at age 60 or older, with antecedent hematologic disorders, therapy-related disease, or relapsed/refractory AML, are eligible. Caregivers must be adults who regularly interact with the patient.
  • Study details: Participants will be assigned to receive either primary or specialty palliative care during their hospital stays. Primary palliative care is provided by oncology clinicians trained in palliative care, while specialty palliative care involves both oncology and palliative care specialists.
Updated on 21 Oct 2025. Study ID: CTO-SCOPE-LEUKEMIA, 21960

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