NCT02975869

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
6.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

March 3, 2026

Status Verified

March 1, 2026

Enrollment Period

2.7 years

First QC Date

November 24, 2016

Last Update Submit

March 1, 2026

Conditions

Acute Myeloid Leukemia

Keywords

LeukemiaAcute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Compare patient quality of life longitudinally using FACT-Leukemia Scores longitudinally Between Study Arms.

    up to 6 months

  • Compare psychological distress (as measured by the Hospital Anxiety and Depression Scale) between Study Arms

    up to 6 months

  • Compare Symptom Burden (as per ESAS) Between Study Arms.

    up to 6 months

  • Compare Patient-Reported PTSD (as per PTSD-Checklist) between study arms

    up to 6 months

  • Compare Patient-Report Of Discussion EOL Care Preferences Between Study Arms

    up to 6 months

  • +3 more secondary outcomes

Study Arms (2)

Standard Leukemia Care

ACTIVE COMPARATOR

Standard Leukemia care

Other: Standard Leukemia Care

Collaborative Palliative and Oncology Care

EXPERIMENTAL

Collaborative care from Palliative Care and Leukemia will be given

Other: Palliative Care

Interventions

Standard Leukemia CareOTHER
Standard Leukemia Care
Palliative CareOTHER
Collaborative Palliative and Oncology Care

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Massachusetts general Hospital

Boston, Massachusetts, 02114, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 16802, United States

Location

Related Publications (2)

  • 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: 38429079DERIVED

  • 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.

    PMID: 33331857DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteLeukemia

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Leukemia, MyeloidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth 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
MD

Study Record Dates

First Submitted

November 24, 2016

First Posted

November 29, 2016

Study Start

January 1, 2017

Primary Completion

September 1, 2019

Study Completion

January 1, 2026

Last Updated

March 3, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(4)