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Palliative Care Delivery for Leukemia (SCOPE-L Trial)

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and weeks: 2, 4, 12, and 24
Awards & highlights

SCOPE-L Trial 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.Check my eligibility
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.See study design
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.

SCOPE-L Trial 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.
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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.
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I have a history of blood disorders.

SCOPE-L Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Quality of Life (QOL)
Secondary outcome measures
Caregiver Anxiety Symptoms
Caregiver Burden
Caregiver Depression Symptoms
+7 more
Other outcome measures
Caregiver Coping
Caregiver Prognostic Understanding
Caregiver-Reported End-of-Life (EOL) Communication
+8 more

SCOPE-L 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

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,196,201 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
551 Previous Clinical Trials
29,995,148 Total Patients Enrolled
Areej El-Jawahri, MDPrincipal InvestigatorMassachusetts General Hospital
18 Previous Clinical Trials
2,212 Total Patients Enrolled

Media Library

Primary Palliative Care Clinical Trial Eligibility Overview. Trial Name: NCT05237258 — N/A
Acute Myeloid Leukemia Research Study Groups: Specialty Palliative Care, Primary Palliative Care
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

May I join this clinical experiment?

"This clinical trial is seeking 2300 individuals aged 18 to 120 who have been diagnosed with myeloid leukemia. In addition, the following criteria must be met: Patients ≥60 years of age experiencing a new diagnosis or relapse, those receiving intensive chemotherapy as part of a hospital-based trial; or undergoing hypomethylating agents +/- additional medications for research purposes and any adult relative/friend that interacts with the patient at least twice weekly. Caregiver inclusion critera also apply."

Answered by AI

How many participants is the maximum capacity for this research endeavor?

"Affirmative. The information from clinicaltrials.gov corroborates that this research is still actively seeking participants, with its first posting occurring on June 1st 2022 and the last edit being made on August 12th 2022. This trial has a need for 2300 patients across 4 sites."

Answered by AI

Does this experiment have any age restrictions for potential participants?

"The age parameters for this trial are clearly outlined in the inclusion criteria: participants must be 18 years old or older, but no more than 120."

Answered by AI

Are there any venues in the U.S. that are currently conducting this experiment?

"This clinical trial is enrolling patients from 4 distinct sites, located in Durham, Rochester, Boston and other cities. It may be beneficial for potential participants to select the location closest to them so as to reduce travel requirements."

Answered by AI

Are individuals still being admitted to this research project?

"As indicated on the clinicaltrials.gov website, this trial is still in search of participants and was recently updated on August 12th 2022, since its initial posting date of June 1st 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia
El-Jawahri, Areej,M.D. 2022. "Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05237258.
~1533 spots leftby Apr 2028
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