Clinical trial NCT02975869: A Collaborative Palliative and Oncology Care Model for Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
Official title: Randomized Trial of a Collaborative Palliative and Oncology Care Model for Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acute Myeloid Leukemia
Keywords: Leukemia
Acute Myeloid Leukemia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Duke University
First posted: 2016-11-29
Enrollment: 160
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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) 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: 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.

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)

Primary outcomes:
measure: Comparison of Patients' quality of life as measured by (FACT-Leukemia) Score at Week-2 Between Study Arms
timeFrame: 2 weeks
Secondary outcomes:
measure: Compare patient quality of life longitudinally using FACT-Leukemia Scores longitudinally Between Study Arms.
timeFrame: up to 6 months
measure: Compare psychological distress (as measured by the Hospital Anxiety and Depression Scale) between Study Arms
timeFrame: up to 6 months
measure: Compare Symptom Burden (as per ESAS) Between Study Arms.
timeFrame: up to 6 months
measure: Compare Patient-Reported PTSD (as per PTSD-Checklist) between study arms
timeFrame: up to 6 months
measure: Compare Patient-Report Of Discussion EOL Care Preferences Between Study Arms
timeFrame: up to 6 months
measure: Compare Rates Of Chemotherapy Administration Within 30 Days Of Death Between The Two Study Arms
timeFrame: up to 6 months
measure: Compare Rates Of Hospitalizations Within 7 Days Of Death Between The Study Arms
timeFrame: up to 6 months
measure: Compare Rates Of Hospice Utilization And Length-Of-Stay In Hospice At The EOL Between The Study Arms.
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts general Hospital
state: Massachusetts
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Massachusetts General Hospital
name: Areej El-Jawahri, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.