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Palliative Care Delivery for Leukemia (SCOPE-L Trial)

Boston, MA
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
Patients with new diagnosis ≥ 60 years of age
Receiving treatment with either a) intensive chemotherapy (7+3) or modification of this regimen on a clinical trial, or a similar intensive regimen requiring prolonged hospitalization; or b) hypomethylating agents +/- additional agents or modification of this regimen on a clinical trial
Must not have
Patients with a diagnosis of acute promyelocytic leukemia (APML)
Patients with AML receiving supportive care alone
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and weeks: 2, 4, 12, and 24
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether primary care doctors can provide the same level of care for cancer patients as specialists.

Who is the study for?
This trial is for hospitalized adults with high-risk acute myeloid leukemia (AML), including those newly diagnosed over 60, with a related prior blood disorder, treatment-related disease, or relapsed/refractory AML. They must be undergoing intensive chemotherapy or treatments requiring prolonged hospitalization. Excluded are patients with acute promyelocytic leukemia, receiving only supportive care, or unable to consent due to psychiatric/cognitive conditions.
What is being tested?
The study compares primary palliative care—comfort care provided by the patient's usual healthcare team—with specialty palliative care given by experts in symptom management and emotional support. It aims to see which approach better improves quality of life, symptoms control, mood stabilization, coping abilities and end-of-life outcomes for AML patients.
What are the potential side effects?
Since this trial focuses on palliative care rather than specific medical treatments like drugs or surgery, side effects are not the main concern as they would be in drug trials. However, there may be differences in comfort levels or psychological impacts between the two types of palliative care being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 60 years or older with a new diagnosis.
Select...
I am undergoing intensive chemotherapy or treatment with hypomethylating agents.
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I am over 18, hospitalized with high-risk AML, and receiving specific treatments.
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My AML cancer has returned or did not respond to initial treatment.
Select...
I have a history of blood disorders.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with acute promyelocytic leukemia.
Select...
I am receiving only supportive care for my AML.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and weeks: 2, 4, 12, and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and weeks: 2, 4, 12, and 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Quality of Life (QOL)
Secondary study objectives
Caregiver Anxiety Symptoms
Caregiver Burden
Caregiver Depression Symptoms
+7 more
Other study objectives
Caregiver Coping
Caregiver Prognostic Understanding
Caregiver-Reported End-of-Life (EOL) Communication
+8 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
Group I: Specialty Palliative CareExperimental Treatment1 Intervention
- Participants will complete baseline self-report assessments at the time of informed consent
Group II: Primary Palliative CareExperimental Treatment1 Intervention
- Participants will complete baseline self-report assessments at the time of informed consent
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Primary Palliative Care
2017
N/A
~30
Specialty Palliative Care
2023
N/A
~70

Find a Location

Closest Location:Dana-Farber Cancer Institute· Boston, MA

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,057 Previous Clinical Trials
13,423,291 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
591 Previous Clinical Trials
27,107,423 Total Patients Enrolled
Areej El-Jawahri, MDPrincipal InvestigatorMassachusetts General Hospital
20 Previous Clinical Trials
3,139 Total Patients Enrolled
Jennifer Temel, MDPrincipal InvestigatorMassachusetts General Hospital
11 Previous Clinical Trials
3,121 Total Patients Enrolled

Media Library

Primary Palliative Care Clinical Trial Eligibility Overview. Trial Name: NCT05237258 — N/A
Adult Acute Myeloid Leukemia Research Study Groups: Specialty Palliative Care, Primary Palliative Care
Adult Acute Myeloid Leukemia Clinical Trial 2023: Primary Palliative Care Highlights & Side Effects. Trial Name: NCT05237258 — N/A
Primary Palliative Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05237258 — N/A
~1183 spots leftby Apr 2028
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