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Palliative + Standard Care for Acute Myeloid Leukemia

N/A

Recruiting

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

Be older than 18 years old

Must not have

Patients already receiving palliative care

Patients receiving intensive chemotherapy (requiring 4-6 week hospitalization)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a palliative care team working with an oncology team will improve end-of-life outcomes and quality of life for AML patients receiving non-intensive therapy.

Who is the study for?

This trial is for English-speaking adults with acute myeloid leukemia (AML) who are undergoing non-intensive therapy, such as hypomethylating agents or targeted therapies. It's not for those on intensive chemo that needs long hospital stays, already in palliative care, getting only supportive care, or with major psychiatric illnesses.

What is being tested?

The study is looking at how combining standard leukemia treatment with palliative care affects the quality of life and end-of-life outcomes for AML patients. The focus is on whether this team approach can improve patient well-being during treatment.

What are the potential side effects?

Since the trial involves standard leukemia treatments and palliative care services rather than new medications, side effects may include typical reactions to current AML therapies and emotional impacts from discussing serious illness.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently receiving palliative care.

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I am undergoing or will undergo intensive chemotherapy that requires a long hospital stay.

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I am only receiving care to help with my cancer symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time from documentation of end-of-life care preferences to death

Secondary study objectives

Compare Rate of hospitalization between the study arms

Patient-report of discussing end-of-life care preferences based on an item from the perception of treatment and prognosis questionnaire

Rate of hospice utilization and length-of-stay in hospice

+4 more

Other study objectives

Compare quality of end-of-life care between the two study arms

Rate of chemotherapy administration

Rates of death in the hospital

+1 more

Awards & 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 Treatment2 Interventions

* 1st palliative care visit within 30 days of randomization in the outpatient or hospital * In outpatient setting: once monthly palliative care visits (or video/ or phone) * During hospital admissions: At least twice weekly palliative care visits

Group II: Standard oncology careActive Control1 Intervention

* Palliative care consults only upon request * Standard oncology care

0 / 3Eligibility criteria met