Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia

Not Applicable

Recruiting

• Conditions: Relapsed Adult AML; Primary Refractory Acute Myeloid Leukemia; High Risk Acute Myeloid Leukemia
• Interventions: Behavioral: Primary Palliative Care; Behavioral: Specialty Palliative Care

• Registration Number: NCT05237258
• Lead Sponsor: Massachusetts General Hospital

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 outcomes in patients with acute myeloid leukemia (AML).

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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-02-02
• Study First Submitted QC: 2022-02-02
• Study First Posted: 2022-02-14
• Study Start: 2022-06-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13
• Primary Completion: 2028-04
• Study Completion: 2029-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2300

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
  • 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

• 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.

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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 or APP] during two previous hospitalizations in the six months prior to enrollment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary Palliative Care	Primary Palliative Care	- Participants will complete baseline self-report assessments at the time of informed consent
Specialty Palliative Care	Specialty Palliative Care	- Participants will complete baseline self-report assessments at the time of informed consent

Primary Outcome Measures

Name	Time	Method
Quality of Life (QOL)	Over 12 weeks	Establish that primary palliative care is non-inferior to specialty palliative care in patient-reported quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leukemia) over 12 weeks.; Higher scores on FACT-Leukemia (range 0-176) indicate a better QOL.

Secondary Outcome Measures

Name	Time	Method
Patient Quality of Life (QOL)	Up to 24 Weeks	Assess whether primary palliative care is non-inferior to specialty palliative care with respect to patient-reported quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leukemia).
Patient Depression Symptoms	Up to 24 Weeks	Assess whether primary palliative care is non-inferior to specialty palliative care with depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS).; Higher scores on HADS depression subscale (range 0-21) indicate greater depression symptoms.
Patient Anxiety Symptoms	Up to 24 Weeks	Assess whether primary palliative care is non-inferior to specialty palliative care with anxiety symptoms as measured by the Hospital Anxiety and Depression Scale (HADS).; Higher scores on HADS anxiety subscale (range 0-21) indicate greater anxiety symptoms.
Patient Post-Traumatic Stress Disorder (PTSD) Symptoms	Up to 24 Weeks	Assess whether primary palliative care is non-inferior to specialty palliative care with respect to post-traumatic stress (PTSD) symptoms as measured by the Post-Traumatic Stress Checklist-Civilian version.; Higher scores on the Post-Traumatic Stress Checklist (range 17-85) indicate greater PTSD symptoms.
End-of-Life (EOL) Communication	Up to 24 Weeks	Assess whether primary palliative care is non-inferior to specialty palliative care with respect to patient reported end-of-life (EOL) communication measured by the Prognostic Awareness Impact Scale (PAIS).; The PAIS includes an item that measures patient self-report of communication about their wishes if they were dying (yes vs. no).
Caregiver Depression Symptoms	Baseline and Weeks: 2, 4, 12, and 24	Assess whether primary palliative care is non-inferior to specialty palliative care with respect to caregiver depression symptoms measured by the Hospital Anxiety and Depression Scale (HADS).; Higher scores on HADS depression subscale (range 0-21) indicate greater depression symptoms.
Caregiver Anxiety Symptoms	Up to 24 Weeks	Assess whether primary palliative care is non-inferior to specialty palliative care with respect to caregiver anxiety symptoms measured by the Hospital Anxiety and Depression Scale (HADS).; Higher scores on HADS anxiety subscale (range 0-21) indicate greater anxiety symptoms.
Caregiver Burden	Up to 24 Weeks	Assess whether primary palliative care is non-inferior to specialty palliative care with respect to caregiver burden measured by the Caregiver Reaction Assessment (CRA).; Higher scores on the CRA (range 24-120) indicate greater caregiving burden.
End-of-Life (EOL) Care	Last 30 days of life	Assess whether primary palliative care is non-inferior to specialty palliative care with respect to chemotherapy administration in the last 30 days of life based on documentation from the Electronic Health Record.
Caregiver Quality of Life (QOL)	Up to 24 Weeks	Assess whether primary palliative care is non-inferior to specialty palliative care with respect to caregiver quality of life measured by the Caregiver Oncology QOL Questionnaire (CARGOQOL).; Higher scores on CARGOQOL (range 0-100) indicate better QOL.

Trial Locations

Locations (20)

Emory University; 🇺🇸 Atlanta, Georgia, United States

Northwestern University; 🇺🇸 Evanston, Illinois, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Fred Hutchinson Cancer Center; 🇺🇸 Seattle, Washington, United States

Indiana University; 🇺🇸 Bloomington, Indiana, United States

University of Rochester; 🇺🇸 Rochester, New York, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States

Stanford University; 🇺🇸 Stanford, California, United States

University of Alabama - Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Colorado Denver I Anschutz Medical Campus; 🇺🇸 Denver, Colorado, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States