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

NCT ID: NCT02975869

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2026-12-01

Brief Summary

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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) and myelodysplastic syndrome (MDS). Palliative care is a medical specialty focused on lessening (or "palliating") symptoms and assisting in coping with serious illness.

Detailed Description

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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 and MDS undergoing treatment.

The investigators aim to find out whether introducing patients and families undergoing AML and MDS 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.

Conditions

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Acute Myeloid Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standard Leukemia Care

Standard Leukemia care

Group Type ACTIVE_COMPARATOR

Standard Leukemia Care

Intervention Type OTHER

Collaborative Palliative and Oncology Care

Collaborative care from Palliative Care and Leukemia will be given

Group Type EXPERIMENTAL

Palliative Care

Intervention Type OTHER

Interventions

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Standard Leukemia Care

Intervention Type OTHER

Palliative Care

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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El-Jawahri, Areej,M.D.

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Areej El-Jawahri, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts general Hospital

Boston, Massachusetts, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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)

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.

Reference Type DERIVED
PMID: 33331857 (View on PubMed)

Other Identifiers

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16-439

Identifier Type: -

Identifier Source: org_study_id

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