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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02975869
Recruitment Status : Active, not recruiting
First Posted : November 29, 2016
Last Update Posted : January 25, 2023
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
El-Jawahri, Areej,M.D., Massachusetts General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Other: Standard Leukemia Care Other: Palliative Care Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomized Trial of a Collaborative Palliative and Oncology Care Model for Patients With Acute Myeloid Leukemia
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : September 1, 2019
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard Leukemia Care
Standard Leukemia care
 Other: Standard Leukemia Care
Experimental: Collaborative Palliative and Oncology Care
Collaborative care from Palliative Care and Leukemia will be given
 Other: Palliative Care


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02975869


Locations
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United States, Massachusetts
Massachusetts general Hospital
Boston, Massachusetts, United States, 02114
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 16802
Sponsors and Collaborators
Massachusetts General Hospital
Duke University
Investigators
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Principal Investigator: Areej El-Jawahri, MD Massachusetts General Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: El-Jawahri, Areej,M.D., MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02975869    
Other Study ID Numbers: 16-439
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: January 25, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by El-Jawahri, Areej,M.D., Massachusetts General Hospital:
Leukemia
Acute Myeloid Leukemia
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms