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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02975869
• Other study ID #: 16-439
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 1, 2024

Study information

• Verified date: June 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: December 1, 2024
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Preleukemia

Intervention

Other:
• Standard Leukemia Care

• Palliative Care

Locations

Country	Name	City	State
United States	Massachusetts general Hospital	Boston	Massachusetts
United States	Ohio State University	Columbus	Ohio
United States	Duke University	Durham	North Carolina
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks
Secondary	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.	up to 6 months
Secondary	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.	up to 6 months
Secondary	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.	up to 6 months
Secondary	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	up to 6 months
Secondary	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	up to 6 months
Secondary	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	up to 6 months
Secondary	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	up to 6 months
Secondary	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	up to 6 months