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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time from documentation of end-of-life care preferences to death
Secondary outcome measures
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 moreOther outcome measures
Compare quality of end-of-life care between the two study arms
Rate of chemotherapy administration
Rates of death in the hospital
+1 moreTrial 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
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,941 Previous Clinical Trials
13,200,349 Total Patients Enrolled
1 Trials studying Blood Cancers
90 Patients Enrolled for Blood Cancers
Areej El-Jawahri, MDPrincipal InvestigatorMassachusetts General Hospital
18 Previous Clinical Trials
4,192 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently receiving palliative care.I have AML and am on a non-intensive treatment plan.I am undergoing or will undergo intensive chemotherapy that requires a long hospital stay.I am only receiving care to help with my cancer symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Standard oncology care
- Group 2: Collaborative palliative and oncology 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for recruitment in this experiment currently?
"The records on clinicaltrials.gov declare that the trial is currently recruiting participants, with its posting date being October 31st 2017 and last update occurring on August 23rd 2022."
Answered by AI
How many individuals are being invited to participate in this trial?
"Affirmative. According to records found on clinicaltrials.gov, this research effort is actively recruiting participants; the trial was initially posted in October of 2017 and has since been revised on August 23rd 2022. Ultimately, 320 individuals must be enrolled from two distinct facilities."
Answered by AI
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