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NCT Number: NCT02975869

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

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.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts general Hospital, Boston, Massachusetts, United States

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About this study

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 undergoing treatment.

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Standard Leukemia care

Other

Palliative Care

Other

Primary outcomes

  1. Comparison of Patients' quality of life as measured by (FACT-Leukemia) Score at Week-2 Between Study Arms

    Time frame: 2 weeks

    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.

Secondary outcomes

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

    Time frame: up to 6 months

    We will compare FACT-leukemia scores longitudinally between study arm. FACT-Leukemia ranges from 0-176 with higher scores indicating better quality of life.

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

    Time frame: up to 6 months

    We will compare patients' psychological distress using the HADS between study arms at week-2 and longitudinally between study arms. The HADS consistent of two subscales assessing anxiety and depression symptoms with scores ranging from 0-21 with higher scores indicating worse psychological distress.

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

    Time frame: up to 6 months

    We will compare patients' symptom burden using the Edmonton Symptom Assessment Scale (ESAS) between the two arms at week-2 and longitudinally. The ESAS ranges from 0-100 with higher scores indicating worse symptom burden.

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

    Time frame: up to 6 months

    We will compare PTSD symptoms as measured by the PTSD-Checklist (PCL) between the two groups at week-2 and longitudinally. PCL scores range from 17-85 with higher scores indicating worse PTSD symptoms

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

    Time frame: up to 6 months

    We will compare patient-reported discussing their EOL care preferences between the two groups

  6. Compare Rates Of Chemotherapy Administration Within 30 Days Of Death Between The Two Study Arms

    Time frame: up to 6 months

    to compare rates of chemotherapy administration near the end of life between the two arms

  7. Compare Rates Of Hospitalizations Within 7 Days Of Death Between The Study Arms

    Time frame: up to 6 months

    to compare rates of hospitalizations within the last week of life between the study arms

  8. Compare Rates Of Hospice Utilization And Length-Of-Stay In Hospice At The EOL Between The Study Arms.

    Time frame: up to 6 months

    to compare rates of hospice utilization and length-of-stay in hospice at the end of life between the two study arms

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Duke University

Registry information

Official study title

Randomized Trial of a Collaborative Palliative and Oncology Care Model for Patients With Acute Myeloid Leukemia

Important dates

Study start
2017
Primary completion
2019
Study completion
2026
First posted
Nov 29, 2016
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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