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

NCT ID: NCT03310918

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-31
• Study Completion Date: 2025-12-31

Brief Summary

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

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.

Conditions

Acute Myeloid Leukemia; Myelodysplastic Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Palliative Care

Intervention Type: OTHER

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

Standard Leukemia care

Intervention Type: OTHER

Standard care per the hospital guideline

Standard oncology care

• Palliative care consults only upon request
• Standard oncology care

Group Type: ACTIVE_COMPARATOR

Standard Leukemia care

Intervention Type: OTHER

Standard care per the hospital guideline

Interventions

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

Intervention Type: OTHER

Standard Leukemia care

Standard care per the hospital guideline

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

El-Jawahri, Areej,M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Areej El-Jawahri, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Ohio State University

Columbus, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38429079 (View on PubMed)

Other Identifiers

17-327

Identifier Type: -

Identifier Source: org_study_id

ECOR grant 230593

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id