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NCT05237258 | RECRUITING | Relapsed Adult AML


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

Massachusetts General Hospital

Information provided by (Responsible Party):

Al -Jawahiri, Areej, M.

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).

Condition or disease

Relapsed Adult AML

Primary Refractory Acute Myeloid Leukemia

High Risk Acute Myeloid Leukemia

Intervention/treatment

Specialty Palliative Care

Primary Palliative Care

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 2300 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia
Actual Study Start Date : 2022-06-01
Estimated Primary Completion Date : 2028-04
Estimated Study Completion Date : 2029-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 120 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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

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

Location Details

NCT05237258


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


ACTIVE NOT RECRUITING

United States, Albama

University of Alabama - Birmingham

Birmingham, Albama, United States, 35294

ACTIVE NOT RECRUITING

United States, California

Stanford University

Stanford, California, United States, 94305

ACTIVE NOT RECRUITING

United States, Colorado

University of Colorado Denver I Anschutz Medical Campus

Denver, Colorado, United States, 80204

ACTIVE NOT RECRUITING

United States, Florida

University of Miami

Miami, Florida, United States, 33146

ACTIVE NOT RECRUITING

United States, Florida

Moffitt Cancer Center

Tampa, Florida, United States, 33612

NOT YET RECRUITING

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30322

ACTIVE NOT RECRUITING

United States, Illinois

Northwestern University

Evanston, Illinois, United States, 60208

NOT YET RECRUITING

United States, Indiana

Indiana University

Bloomington, Indiana, United States, 47405

NOT YET RECRUITING

United States, Maryland

Johns Hopkins University

Baltimore, Maryland, United States, 21218

RECRUITING

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02115

RECRUITING

United States, Massachusetts

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

RECRUITING

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

ACTIVE NOT RECRUITING

United States, New York

University of Rochester

Rochester, New York, United States, 14627

NOT YET RECRUITING

United States, North Carolina

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599

RECRUITING

United States, North Carolina

Duke University

Durham, North Carolina, United States, 27708

ACTIVE NOT RECRUITING

United States, Ohio

Ohio State University

Columbus, Ohio, United States, 43210

ACTIVE NOT RECRUITING

United States, Oregon

Oregon Health & Science University

Portland, Oregon, United States, 97239

RECRUITING

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

ACTIVE NOT RECRUITING

United States, Washington

Fred Hutchinson Cancer Center

Seattle, Washington, United States, 98109

ACTIVE NOT RECRUITING

United States, Wisconsin

University of Wisconsin

Madison, Wisconsin, United States, 53715

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