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

NCT03310918 | Active Not Recruiting

• 2 other identifiers: 17-327ECOR grant 230593
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 2

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

Conditions

Acute Myeloid Leukemia; Myelodysplastic Syndromes

Keywords

AML; MDS; Palliative care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Rates of documentation of end-of-life care preferences at least one week prior to death.

  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

  up to 2 years

• Compare Rate of hospitalization between the study arms

  up to 30 days

• Rate of hospice utilization and length-of-stay in hospice

  up to 2 years

• compare quality of life

  up to six months

Other Outcomes (4)

• Rate of chemotherapy administration

  up to 30 days prior to death

• Rates of death in the hospital

  up to 2 years

• caregiver-reported discussion of end-of-life care preferences as measured by the perception of treatment and prognosis questionnaire

  one month

Study Arms (2)

Collaborative palliative and oncology care

EXPERIMENTAL

* 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; Other: Standard Leukemia care

Standard oncology care

ACTIVE COMPARATOR

* Palliative care consults only upon request * Standard oncology care

Other: Standard Leukemia care

Interventions

Palliative Care 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

Collaborative palliative and oncology care

Standard Leukemia care OTHER

Standard care per the hospital guideline

Collaborative palliative and oncology care; Standard oncology care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• 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.

  PMID: 38429079 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Areej El-Jawahri, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 16, 2017
• Study Start: October 31, 2017
• Primary Completion: April 1, 2023
• Study Completion: December 31, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)