Clinical trial NCT05237258: Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia
Official title: Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Relapsed Adult AML
Primary Refractory Acute Myeloid Leukemia
High Risk Acute Myeloid Leukemia
Keywords: Relapsed Adult AML
Primary Refractory Acute Myeloid Leukemia
High Risk Acute Myeloid Leukemia
Caregivers
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2022-02-14
Enrollment: 2300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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
  * 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.

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

Primary outcomes:
measure: Quality of Life (QOL)
timeFrame: Over 12 weeks
Secondary outcomes:
measure: Patient Quality of Life (QOL)
timeFrame: Up to 24 Weeks
measure: Patient Depression Symptoms
timeFrame: Up to 24 Weeks
measure: Patient Anxiety Symptoms
timeFrame: Up to 24 Weeks
measure: Patient Post-Traumatic Stress Disorder (PTSD) Symptoms
timeFrame: Up to 24 Weeks
measure: End-of-Life (EOL) Communication
timeFrame: Up to 24 Weeks
measure: End-of-Life (EOL) Care
timeFrame: Last 30 days of life
measure: Caregiver Quality of Life (QOL)
timeFrame: Up to 24 Weeks
measure: Caregiver Burden
timeFrame: Up to 24 Weeks
measure: Caregiver Depression Symptoms
timeFrame: Baseline and Weeks: 2, 4, 12, and 24
measure: Caregiver Anxiety Symptoms
timeFrame: Up to 24 Weeks
Other outcomes:
measure: Patient Prognostic Understanding
timeFrame: Up to 24 weeks
measure: Patient Coping
timeFrame: Up to 24 weeks
measure: Hospitalization
timeFrame: Last 30 days of life
measure: Intensive Care Unit (ICU) Admissions
timeFrame: Last 30 days of life
measure: Hospice Utilization
timeFrame: Last 30 days of life
measure: Hospice Length of Stay
timeFrame: Last 30 days of life
measure: Patient Symptom Burden
timeFrame: Up to 24 weeks
measure: Patient Perception of Care
timeFrame: Up to 24 weeks
measure: Caregiver-Reported End-of-Life (EOL) Communication
timeFrame: Up to 24 weeks
measure: Caregiver Prognostic Understanding
timeFrame: Up to 24 weeks
measure: Caregiver Coping
timeFrame: Up to 24 weeks
Locations:
city: Birmingham
country: United States
facility: University of Alabama - Birmingham
state: Alabama
city: Stanford
country: United States
facility: Stanford University
state: California
city: Denver
country: United States
facility: University of Colorado Denver I Anschutz Medical Campus
state: Colorado
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Bloomington
country: United States
facility: Indiana University
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Massachusetts General Hospital
name: Areej El-Jawahri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Jennifer Temel, MD
role: PRINCIPAL_INVESTIGATOR
References: