A Collaborative Palliative and Oncology Care Model for Patients With Acute Myeloid Leukemia

Randomized Trial of a Collaborative Palliative and Oncology Care Model for Patients With Acute Myeloid Leukemia

This research study is evaluating the impact a collaborative palliative care and oncology team will have on the quality of life, symptoms, mood, and end of life outcomes of patients with acute myeloid leukemia (AML). Palliative care is a medical specialty focused on lessening (or "palliating") symptoms and assisting in coping with serious illness.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Myeloid Leukemia
• Intervention / Treatment: Other: Standard Leukemia Care; Other: Palliative Care

Detailed Description

The main purpose of this study is to compare two types of care - standard leukemia oncology care and standard leukemia oncology care with collaborative involvement of palliative care clinicians to see which is better for improving the experience of patients and families with AML undergoing treatment.

The investigators aim to find out whether introducing patients and families undergoing AML treatment to the palliative care team that specializes in symptom management can improve the physical and psychological symptoms that patients and families experience during their hospitalizations for their leukemia care as well as enhance the quality of patients' end of life care.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 16802
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Hospitalized patients with high-risk AML, defined as:
• Newly diagnosed patients with AML ≥ 60 years of age
• Newly diagnosed AML with antecedent hematologic disorder
• Newly diagnosed therapy-related AML
• Relapsed AML
• Primary refractory AML

Exclusion Criteria:

• Patients already receiving palliative care
• Major psychiatric illness or comorbid conditions prohibiting compliance with study procedures.
• A diagnosis of acute promyelocytic leukemia (APML)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Leukemia Care; Standard Leukemia care	Other: Standard Leukemia Care
Experimental: Collaborative Palliative and Oncology Care; Collaborative care from Palliative Care and Leukemia will be given	Other: Palliative Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Patients' quality of life as measured by (FACT-Leukemia) Score at Week-2 Between Study Arms	We will compare patients' FACT-Leukemia scores at week-2 adjusting for baseline scores. FACT-Leukemia ranges from 0-176 with higher scores indicating better quality of life.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare patient quality of life longitudinally using FACT-Leukemia Scores longitudinally Between Study Arms.	We will compare FACT-leukemia scores longitudinally between study arm. FACT-Leukemia ranges from 0-176 with higher scores indicating better quality of life.	up to 6 months
Compare psychological distress (as measured by the Hospital Anxiety and Depression Scale) between Study Arms	We will compare patients' psychological distress using the HADS between study arms at week-2 and longitudinally between study arms. The HADS consistent of two subscales assessing anxiety and depression symptoms with scores ranging from 0-21 with higher scores indicating worse psychological distress.	up to 6 months
Compare Symptom Burden (as per ESAS) Between Study Arms.	We will compare patients' symptom burden using the Edmonton Symptom Assessment Scale (ESAS) between the two arms at week-2 and longitudinally. The ESAS ranges from 0-100 with higher scores indicating worse symptom burden.	up to 6 months
Compare Patient-Reported PTSD (as per PTSD-Checklist) between study arms	We will compare PTSD symptoms as measured by the PTSD-Checklist (PCL) between the two groups at week-2 and longitudinally. PCL scores range from 17-85 with higher scores indicating worse PTSD symptoms	up to 6 months
Compare Patient-Report Of Discussion EOL Care Preferences Between Study Arms	We will compare patient-reported discussing their EOL care preferences between the two groups	up to 6 months
Compare Rates Of Chemotherapy Administration Within 30 Days Of Death Between The Two Study Arms	to compare rates of chemotherapy administration near the end of life between the two arms	up to 6 months
Compare Rates Of Hospitalizations Within 7 Days Of Death Between The Study Arms	to compare rates of hospitalizations within the last week of life between the study arms	up to 6 months
Compare Rates Of Hospice Utilization And Length-Of-Stay In Hospice At The EOL Between The Study Arms.	to compare rates of hospice utilization and length-of-stay in hospice at the end of life between the two study arms	up to 6 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Duke University
• Investigators: Principal Investigator: Areej El-Jawahri, MD, Massachusetts General Hospital

Publications and helpful links

General Publications

• El-Jawahri A, LeBlanc TW, Kavanaugh A, Webb JA, Jackson VA, Campbell TC, O'Connor N, Luger SM, Gafford E, Gustin J, Bhatnagar B, Walker AR, Fathi AT, Brunner AM, Hobbs GS, Nicholson S, Davis D, Addis H, Vaughn D, Horick N, Greer JA, Temel JS. Effectiveness of Integrated Palliative and Oncology Care for Patients With Acute Myeloid Leukemia: A Randomized Clinical Trial. JAMA Oncol. 2021 Feb 1;7(2):238-245. doi: 10.1001/jamaoncol.2020.6343.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): September 1, 2019
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 24, 2016
• First Submitted That Met QC Criteria: November 28, 2016
• First Posted (Estimated): November 29, 2016

Study Record Updates

• Last Update Posted (Actual): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 11, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Acute Myeloid Leukemia; Leukemia
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: 16-439

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO