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Palliative Care + Standard Leukemia Care for Acute Myeloid Leukemia
N/A
Waitlist Available
Led By Areej El-Jawahri, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Primary refractory AML
Relapsed AML
Must not have
Patients already receiving palliative care
A diagnosis of acute promyelocytic leukemia (APML)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is looking at whether having a palliative care team work with an oncology team will improve outcomes for patients with AML.
Who is the study for?
This trial is for patients 60 years or older with newly diagnosed acute myeloid leukemia (AML), including those with a history of hematologic disorders, therapy-related AML, relapsed or primary refractory AML. It's also open to hospitalized high-risk AML patients. Those with severe psychiatric illness, other major comorbid conditions, acute promyelocytic leukemia (APML), or already in palliative care cannot participate.
What is being tested?
The study is testing the effects of combining palliative care—a specialty aimed at easing symptoms and helping cope with serious illness—with standard leukemia treatment on quality of life, symptom management, mood, and end-of-life outcomes in AML patients.
What are the potential side effects?
While this trial focuses on supportive care rather than direct medical treatments like chemotherapy or drugs that may have extensive side effects lists, palliative interventions can sometimes include medications that might cause drowsiness, nausea or other mild side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My AML did not respond to initial treatment.
Select...
My AML cancer has returned after treatment.
Select...
I have been recently diagnosed with AML caused by previous cancer treatment.
Select...
I am 60 or older and have been diagnosed with high-risk AML.
Select...
I have been recently diagnosed with AML following a blood disorder.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently receiving palliative care.
Select...
I have been diagnosed with acute promyelocytic leukemia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Comparison of Patients' quality of life as measured by (FACT-Leukemia) Score at Week-2 Between Study Arms
Secondary study objectives
Compare Patient-Report Of Discussion EOL Care Preferences Between Study Arms
Compare Patient-Reported PTSD (as per PTSD-Checklist) between study arms
Compare Rates Of Chemotherapy Administration Within 30 Days Of Death Between The Two Study Arms
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Collaborative Palliative and Oncology CareExperimental Treatment1 Intervention
Collaborative care from Palliative Care and Leukemia will be given
Group II: Standard Leukemia CareActive Control1 Intervention
Standard Leukemia care
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,006 Previous Clinical Trials
13,307,122 Total Patients Enrolled
Duke UniversityOTHER
2,451 Previous Clinical Trials
2,971,599 Total Patients Enrolled
Areej El-Jawahri, MDPrincipal InvestigatorMassachusetts General Hospital
20 Previous Clinical Trials
5,279 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My AML did not respond to initial treatment.My AML cancer has returned after treatment.I have been recently diagnosed with AML caused by previous cancer treatment.I am 60 or older and have been diagnosed with high-risk AML.I have been recently diagnosed with AML following a blood disorder.I am currently receiving palliative care.I have been diagnosed with acute promyelocytic leukemia.
Research Study Groups:
This trial has the following groups:- Group 1: Collaborative Palliative and Oncology Care
- Group 2: Standard Leukemia Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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