A Collaborative Palliative and Leukemia Care Model for Patients With AML and MDS Receiving Non-Intensive Therapy

Randomized Trial of a Collaborative Palliative and Leukemia Care Model for Patients With AML and MDS Receiving Non-Intensive Therapy

This research study is evaluating the impact a collaborative palliative care and oncology team will have on end-of-life outcomes, quality of end-of-life care, and the quality of life, symptoms, and mood of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) receiving non-intensive therapy

Study Overview

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

Detailed Description

Frequently people undergoing treatment for AML or MDS experience physical and emotional symptoms during the course of their illness. These can be very distressing to both patients and their caregivers. Patients with AML or MDS receiving non-intensive therapy also often experience a rapid decline in their health status and have a limited prognosis. Despite their limited life-expectancy, they rarely engage in discussion with their clinicians regarding their goals and preferences for care at the end of life. The study doctors want to know if the early introduction of a team of clinicians that specialize in the lessening (palliation) of many of these distressing symptoms and have expertise in enhancing communication about prognosis and illness trajectory may improve the overall care of patients with acute leukemia.

This team of clinicians is called the palliative care team and they focus on ways to improve the participant's pain and other symptom management (nausea, fatigue, shortness of breath, anxiety, etc.) and to assist the participant and the participant's caregivers in coping with the emotional and social issues associated with their diagnosis. The team consists of physicians and advance practice nurses who have been specially trained in the care of patients facing serious illness.

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

The purpose of this research study is to find out whether introducing patients undergoing treatment for AML or MDS to the palliative care team can improve their end-of-life communication, understanding of their prognosis, and their physical and psychological symptoms during the course of their illness.

• Study Type: Interventional
• Enrollment (Estimated): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with AML receiving non-intensive therapy including hypomethylating agents, single-agent chemotherapy, targeted therapy agents, or single or combination non-intensive agents offered on a clinical trial, including the following populations:

  • Newly diagnosed AML
  • Relapsed AML
  • Primary refractory AML
• The ability to provide informed consent
• The ability to comprehend English or complete questionnaires with minimal assistance of an interpreter

Exclusion Criteria:

• Patients not receiving care at MGH
• Patients receiving intensive chemotherapy (requiring 4-6 week hospitalization)
• Patients receiving supportive care alone
• Major psychiatric illness or co-morbid conditions prohibiting compliance with study procedures
• Patients already receiving palliative care

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
Experimental: Collaborative palliative and oncology care; 1st palliative care visit within 30 days of randomization in the outpatient or hospital; In outpatient setting: once monthly palliative care visits (or video/ or phone); During hospital admissions: At least twice weekly palliative care visits	Other: Palliative Care; Specialized medical care for people with serious illness. This type of care is focused on providing relief from the symptoms and stress of a serious illness. The goal is to improve quality of life for both the patient and the family; Other: Standard Leukemia care; Standard care per the hospital guideline
Active Comparator: Standard oncology care; Palliative care consults only upon request; Standard oncology care	Other: Standard Leukemia care; Standard care per the hospital guideline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from documentation of end-of-life care preferences to death	comparison of time from documentation of end-of-life care preferences to death in the electronic health records	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of documentation of end-of-life care preferences at least one week prior to death.	Comparison of the rate of documentation of end-of-life care preferences at least one week prior to death in the electronic health record	up to 2 years
Patient-report of discussing end-of-life care preferences based on an item from the perception of treatment and prognosis questionnaire	comparison of patient-report of discussion end-of-life care preferences between the study arms	up to 2 years
Compare Rate of hospitalization between the study arms	Compare rates of hospitalizations within 30 days of death between the study arms	up to 30 days
Rate of hospice utilization and length-of-stay in hospice	Compare rates of hospice utilization and length-of-stay in hospice at the end of life between the study arms	up to 2 years
compare quality of life	Compare quality of life (FACT-Leuk) at week-12 and longitudinally between the study arms. Score range 0-176 (higher scores indicating better quality of life)	up to six months
compare symptom burden	Compare symptom burden (ESAS) at week-12 and longitudinally between the study arms. the ESAS score range 0-100 with higher scores indicating worse symptom burden.	up to six months
compare mood	Compare change in mood (HADS) at week-12, and longitudinally between the study arms. HADS measures depression and anxiety symptoms (subscale range 0-21) higher scores indicating worse mood symptoms	up to six months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
caregiver-reported discussion of end-of-life care preferences as measured by the perception of treatment and prognosis questionnaire	compare caregiver-reported discussion of end-of-life care preferences between the study arms at one month	one month
Rate of chemotherapy administration	compare rate of chemotherapy administration within 30 days of death between the two study arms	up to 30 days prior to death
Rates of death in the hospital	compare rates of death in the hospital between the two study arms	up to 2 years
Compare quality of end-of-life care between the two study arms	compare quality of end-of-life care (FAMCARE) as reported by caregivers between the two study arms. FAMCARE score range 0-100, higher scores indicate better quality of end-of-life care	up to 2 years

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Jensen-Battaglia M, Sohn MB, Consagra W, Wang Y, Zhang Z, LoCastro M, Davis J, Buettner K, Mortaz S, El-Jawahri AR, Loh KP. Trajectories of physical well-being among adults with acute myeloid leukemia. Blood Adv. 2024 Jun 11;8(11):2612-2621. doi: 10.1182/bloodadvances.2023011804.

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2017
• Primary Completion (Actual): April 1, 2023
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 2, 2017
• First Submitted That Met QC Criteria: October 10, 2017
• First Posted (Actual): October 16, 2017

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Palliative care; AML; MDS
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Bone Marrow Diseases; Leukemia; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Palliative Care
• Other Study ID Numbers: 17-327; ECOR grant 230593 (Other Grant/Funding Number: ECOR)

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No