Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia
SCOPE-L
1 other identifier
interventional
2,300
1 country
20
Brief Summary
This research study is evaluating whether primary palliative care is an alternative strategy to specialty palliative care for improving quality of life, symptoms, mood, coping, and end of life outcomes in patients with acute myeloid leukemia (AML).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2022
Longer than P75 for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2022
CompletedFirst Posted
Study publicly available on registry
February 14, 2022
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
July 25, 2025
July 1, 2025
5.8 years
February 2, 2022
July 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of Life (QOL)
Establish that primary palliative care is non-inferior to specialty palliative care in patient-reported quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leukemia) over 12 weeks. Higher scores on FACT-Leukemia (range 0-176) indicate a better QOL.
Over 12 weeks
Secondary Outcomes (10)
Patient Quality of Life (QOL)
Up to 2 Weeks
Patient Depression Symptoms
Up to 12 Weeks
Patient Anxiety Symptoms
Up to 12 Weeks
Patient Post-Traumatic Stress Disorder (PTSD) Symptoms
Up to 12 Weeks
End-of-Life (EOL) Communication
Up to 12 Weeks
- +5 more secondary outcomes
Other Outcomes (11)
Patient Prognostic Understanding
Up to 24 weeks
Patient Coping
Up to 24 weeks
Hospitalization
Last 30 days of life
- +8 more other outcomes
Study Arms (2)
Specialty Palliative Care
EXPERIMENTAL\- Participants will complete baseline self-report assessments at the time of informed consent
Primary Palliative Care
EXPERIMENTAL\- Participants will complete baseline self-report assessments at the time of informed consent
Interventions
Participants assigned to specialty palliative care will be cared for by both oncology and palliative care clinicians during their hospital stays for AML.
Participants assigned primary palliative care will be cared for by oncology clinicians who have been trained in palliative care during the hospital stays for AML.
Eligibility Criteria
You may qualify if:
- Hospitalized patients (age ≥ 18 years) with high-risk AML defined as:
- Patients with new diagnosis ≥ 60 years of age
- An antecedent hematologic disorder
- Therapy related-disease
- Relapsed or primary refractory AML
- Within five business days of initiating therapy 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.
- Adult (≥18 years) relative or friend of a participating patient who the patient identifies as living with or has in-person contact with them at least twice per week.
You may not qualify if:
- Patients with a diagnosis of acute promyelocytic leukemia (APML)
- Patients with AML receiving supportive care alone
- Patients with psychiatric or cognitive conditions which the treating clinicians believe prohibits informed consent or compliance with study procedures
- Patients seen by a palliative care clinician (MD, DO, APP) during two previous hospitalizations in the six months prior to enrollment
- Patients expected to be discharged within 2 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
University of Alabama - Birmingham
Birmingham, Alabama, 35294, United States
Stanford University
Stanford, California, 94305, United States
University of Colorado Denver I Anschutz Medical Campus
Denver, Colorado, 80204, United States
University of Miami
Miami, Florida, 33146, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Emory University
Atlanta, Georgia, 30322, United States
Northwestern University
Evanston, Illinois, 60208, United States
Indiana University
Bloomington, Indiana, 47405, United States
Johns Hopkins University
Baltimore, Maryland, 21218, United States
Massachusetts General Hospital
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of Rochester
Rochester, New York, 14627, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University
Durham, North Carolina, 27708, United States
Ohio State University
Columbus, Ohio, 43210, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
University of Wisconsin
Madison, Wisconsin, 53715, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Areej El-Jawahri, MD
Massachusetts General Hospital
- PRINCIPAL INVESTIGATOR
Jennifer Temel, MD
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 2, 2022
First Posted
February 14, 2022
Study Start
June 1, 2022
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2029
Last Updated
July 25, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Partners Innovations team at http://www.partners.org/innovation
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.