A Collaborative Palliative and Oncology Care Model for Patients With Acute Myeloid Leukemia
Primary Purpose
Acute Myeloid Leukemia
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Leukemia Care
Palliative Care
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Myeloid Leukemia focused on measuring Leukemia, Acute Myeloid Leukemia
Eligibility 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)
Sites / Locations
- Massachusetts general Hospital
- Duke University
- Ohio State University
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Leukemia Care
Collaborative Palliative and Oncology Care
Arm Description
Standard Leukemia care
Collaborative care from Palliative Care and Leukemia will be given
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Compare patient quality of life longitudinally using FACT-Leukemia Scores longitudinally Between Study Arms.
We will compare FACT-leukemia scores longitudinally between study arm. FACT-Leukemia ranges from 0-176 with higher scores indicating better quality of life.
Compare psychological distress (as measured by the Hospital Anxiety and Depression Scale) between Study Arms
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.
Compare Symptom Burden (as per ESAS) Between Study Arms.
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.
Compare Patient-Reported PTSD (as per PTSD-Checklist) between study arms
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
Compare Patient-Report Of Discussion EOL Care Preferences Between Study Arms
We will compare patient-reported discussing their EOL care preferences between the two groups
Compare Rates Of Chemotherapy Administration Within 30 Days Of Death Between The Two Study Arms
to compare rates of chemotherapy administration near the end of life between the two arms
Compare Rates Of Hospitalizations Within 7 Days Of Death Between The Study Arms
to compare rates of hospitalizations within the last week of life between the study arms
Compare Rates Of Hospice Utilization And Length-Of-Stay In Hospice At The EOL Between The Study Arms.
to compare rates of hospice utilization and length-of-stay in hospice at the end of life between the two study arms
Full Information
NCT ID
NCT02975869
First Posted
November 24, 2016
Last Updated
January 24, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Duke University
1. Study Identification
Unique Protocol Identification Number
NCT02975869
Brief Title
A Collaborative Palliative and Oncology Care Model for Patients With Acute Myeloid Leukemia
Official Title
Randomized Trial of a Collaborative Palliative and Oncology Care Model for Patients With Acute Myeloid Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Duke University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
Leukemia, Acute Myeloid Leukemia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Leukemia Care
Arm Type
Active Comparator
Arm Description
Standard Leukemia care
Arm Title
Collaborative Palliative and Oncology Care
Arm Type
Experimental
Arm Description
Collaborative care from Palliative Care and Leukemia will be given
Intervention Type
Other
Intervention Name(s)
Standard Leukemia Care
Intervention Type
Other
Intervention Name(s)
Palliative Care
Primary Outcome Measure Information:
Title
Comparison of Patients' quality of life as measured by (FACT-Leukemia) Score at Week-2 Between Study Arms
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Compare patient quality of life longitudinally using FACT-Leukemia Scores longitudinally Between Study Arms.
Description
We will compare FACT-leukemia scores longitudinally between study arm. FACT-Leukemia ranges from 0-176 with higher scores indicating better quality of life.
Time Frame
up to 6 months
Title
Compare psychological distress (as measured by the Hospital Anxiety and Depression Scale) between Study Arms
Description
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.
Time Frame
up to 6 months
Title
Compare Symptom Burden (as per ESAS) Between Study Arms.
Description
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.
Time Frame
up to 6 months
Title
Compare Patient-Reported PTSD (as per PTSD-Checklist) between study arms
Description
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
Time Frame
up to 6 months
Title
Compare Patient-Report Of Discussion EOL Care Preferences Between Study Arms
Description
We will compare patient-reported discussing their EOL care preferences between the two groups
Time Frame
up to 6 months
Title
Compare Rates Of Chemotherapy Administration Within 30 Days Of Death Between The Two Study Arms
Description
to compare rates of chemotherapy administration near the end of life between the two arms
Time Frame
up to 6 months
Title
Compare Rates Of Hospitalizations Within 7 Days Of Death Between The Study Arms
Description
to compare rates of hospitalizations within the last week of life between the study arms
Time Frame
up to 6 months
Title
Compare Rates Of Hospice Utilization And Length-Of-Stay In Hospice At The EOL Between The Study Arms.
Description
to compare rates of hospice utilization and length-of-stay in hospice at the end of life between the two study arms
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Areej El-Jawahri, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts general Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33331857
Citation
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.
Results Reference
derived
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A Collaborative Palliative and Oncology Care Model for Patients With Acute Myeloid Leukemia
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