Relapsed Adult AMLSCOPE-LNCT05237258
Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia
A study testing Specialty Palliative Care and Primary Palliative Care in people with Relapsed Adult AML and Primary Refractory Acute Myeloid Leukemia, run by Massachusetts General Hospital at 20 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Relapsed Adult AML, Primary Refractory Acute Myeloid Leukemia, High Risk Acute Myeloid Leukemia
- What is being tested?
- Specialty Palliative Care and Primary Palliative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,300 participants
- Where
- 20 sitesUnited States
- Study dates
- 1 Jun 2022to Apr 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient Inclusion Criteria
- 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
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- 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.
- Caregiver Inclusion Criteria
- 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.
Who cannot join
- Patient Exclusion Criteria
- 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
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Chardria S Trotter, MPH, MBA contact
20 sites in 1 country
United States20 sites, 20 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
Dio Kavalieratos, MD, d.kavalieratos@emory.edu
Martha Arellano, MD, marella@emory.edu
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21218
Corey Tapper, MD, ctapper1@jhmi.edu
B. Douglas Smith, MD, bdsmith@jhmi.edu
- Recruiting
University of Alabama - Birmingham
Birmingham, Alabama, 35294
Richard Taylor, PhD, rtaylor@uabmc.edu
Omer Jamy, MD, omerjamy@uabmc.edu
- Recruiting
Indiana University
Bloomington, Indiana, 47405
Larry Cripe, MD, lcripe@iu.edu
James Cleary, MD, jfcleary@iu.edu
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02115
Areej El-Jawahri, MD, 617-724-4000, ael-jawahri@mgb.org
Areej El-Jawahri, MD
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Oreofe Odejide, MD, MPH, oreofe_odejide@dfci.harvard.edu
James Tulsky, MD, jamesa_tulsky@dfci.harvard.edu
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Laura Hanson, MD, MPH, laura_hanson@med.unc.edu
William Wood, Jr., MD, william_wood@med.unc.edu
- Recruiting
Ohio State University
Columbus, Ohio, 43210
Erin Stevens, DO, erin.stevens@osumc.edu
Alice Mims, MD, Alice.Mims@osumc.edu
- Recruiting
University of Colorado Denver I Anschutz Medical Campus
Denver, Colorado, 80204
Stacy Fischer, MD, STACY.FISCHER@CUANSCHUTZ.EDU
Christine McMahon, MD, CHRISTINE.MCMAHON@CUANSCHUTZ.EDU
- Recruiting
Duke University
Durham, North Carolina, 27708
Thomas LeBlanc, MD, Thomas.LeBlanc@duke.edu
Wil Santivasi, MD, wil.santivasi@duke.edu
- Recruiting
Northwestern University
Evanston, Illinois, 60208
Jessica Altman, MD, jaltman@nm.org
Jayson Neagle, MD, jayson.neagle@nm.org
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53715
Priyanka Pophali, MD, pophali@wisc.edu
Meaghan Trainor, MD, mtrainor@medicine.wisc.edu
- Recruiting
University of Miami
Miami, Florida, 33146
Lara Traeger, PhD, ltraeger@miami.edu
Michael Huber, MD, mth131@med.miami.edu
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Selina Luger, MD, Selina.Luger@Pennmedicine.upenn.edu
Kathryn McGrath, MD, Kathryn.Mcgrath@Pennmedicine.upenn.edu
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Jason Webb, MD, webbja@ohsu.edu
Rachel Cook, MD, MS, coora@ohsu.edu
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Jacob Strand, MD, strand.jacob@mayo.edu
Hassan Alkhateeb, MD, alkhateeb.hassan@mayo.edu
- Recruiting
University of Rochester
Rochester, New York, 14627
Kah Poh Loh, MD, kahpoh_loh@urmc.rochester.edu
Paul Vermilion, MD, Paul_Vermilion@URMC.Rochester.edu
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Mohamed Sorror, MD, MSc, msorror@fredhutch.org
James Fausto, PhD, jfausto@uw.edu
- Recruiting
Stanford University
Stanford, California, 94305
Karl Lorenz, MD, kalorenz@stanford.edu
Gabriel Mannis, MD, gmannis@stanford.edu
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Sara Tinsley-Vance, PhD, Sara.TinsleyVance@moffitt.org
David Craig, PharmD, David.Craig@moffitt.org
About this study
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).
Read the detailed description
Patients with newly diagnosed AML confront a sudden and life-threatening diagnosis, requiring an immediate disruption of their life and an urgent hospitalization to begin therapy. During their hospitalization for chemotherapy, patients with AML often experience difficult physical symptoms that negatively impact their quality of life and physical function. Patients with AML also experience significant psychological distress as they combat the abrupt onset of illness, uncertainty regarding their prognosis, physical and social isolation during hospitalization, and complete loss of independence. The abrupt onset of these symptoms can be distressing to both the patient and their family and friends (also called "caregivers").
Research has shown that early involvement of a team of clinicians specializing in lessening (or "palliating") these physical and emotional symptoms and helping patients and their caregivers cope with AML improves their quality of life and experience with their illness. This team is called "specialty palliative care" and consists of physicians and advanced practice providers who work closely and collaboratively with the oncology team to care for patients and caregivers. Research has also shown that training oncology clinicians to incorporate palliative care skills into their practice, called "primary palliative care," is an alternative strategy to having specialty palliative care clinicians care for patients with leukemia.
The purpose of this study is to determine whether specialty palliative care or primary palliative care is the best way to improve the quality of life and experience of patients with AML and their caregivers. This study will randomly assign hospitals to deliver either specialty palliative care or primary palliative care for patients with AML. Participants in this study will receive either specialty or primary palliative care during their hospital stays based upon which strategy their hospital has been assigned to. Participants assigned to specialty palliative care will be care for by both oncology and palliative care clinicians during their hospital stays for AML. Participants assigned to primary palliative care will be cared for by oncology clinicians who have been trained in palliative care during their hospital stays for AML.
- Conditions
- Relapsed Adult AML, Primary Refractory Acute Myeloid Leukemia, High Risk Acute Myeloid Leukemia
- Being tested
- Specialty Palliative Care, Primary Palliative Care
- Keywords
- Relapsed Adult AML, Primary Refractory Acute Myeloid Leukemia, High Risk Acute Myeloid Leukemia, Caregivers
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specialty Palliative CareBehavioural
Participants assigned to specialty palliative care will be cared for by both oncology and palliative care clinicians during their hospital stays for AML.
Primary Palliative CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Specialty Palliative Care | Experimental | - Participants will complete baseline self-report assessments at the time of informed consent Receives: Behavioral: Specialty Palliative Care |
| Primary Palliative Care | Experimental | - Participants will complete baseline self-report assessments at the time of informed consent Receives: Behavioral: Primary Palliative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Over 12 weeks
Secondary outcomes (10)
Patient Quality of Life (QOL)
Assess whether primary palliative care is non-inferior to specialty palliative care with respect to patient-reported quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leukemia).
Measured: Up to 2 Weeks
Patient Depression Symptoms
Assess whether primary palliative care is non-inferior to specialty palliative care with depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS).
Higher scores on HADS depression subscale (range 0-21) indicate greater depression symptoms.
Measured: Up to 12 Weeks
Patient Anxiety Symptoms
Assess whether primary palliative care is non-inferior to specialty palliative care with anxiety symptoms as measured by the Hospital Anxiety and Depression Scale (HADS).
Higher scores on HADS anxiety subscale (range 0-21) indicate greater anxiety symptoms.
Measured: Up to 12 Weeks
Patient Post-Traumatic Stress Disorder (PTSD) Symptoms
Assess whether primary palliative care is non-inferior to specialty palliative care with respect to post-traumatic stress (PTSD) symptoms as measured by the Post-Traumatic Stress Checklist-Civilian version.
Higher scores on the Post-Traumatic Stress Checklist (range 17-85) indicate greater PTSD symptoms.
Measured: Up to 12 Weeks
End-of-Life (EOL) Communication
Assess whether primary palliative care is non-inferior to specialty palliative care with respect to patient reported end-of-life (EOL) communication measured by the Prognostic Awareness Impact Scale (PAIS).
The PAIS includes an item that measures patient self-report of communication about their wishes if they were dying (yes vs. no).
Measured: Up to 12 Weeks
End-of-Life (EOL) Care
Assess whether primary palliative care is non-inferior to specialty palliative care with respect to chemotherapy administration in the last 30 days of life based on documentation from the Electronic Health Record.
Measured: Last 30 days of life
Caregiver Quality of Life (QOL)
Assess whether primary palliative care is non-inferior to specialty palliative care with respect to caregiver quality of life measured by the Caregiver Oncology QOL Questionnaire (CARGOQOL).
Higher scores on CARGOQOL (range 0-100) indicate better QOL.
Measured: Up to 12 Weeks
Caregiver Burden
Assess whether primary palliative care is non-inferior to specialty palliative care with respect to caregiver burden measured by the Caregiver Reaction Assessment (CRA).
Higher scores on the CRA (range 24-120) indicate greater caregiving burden.
Measured: Up to 12 Weeks
Caregiver Depression Symptoms
Assess whether primary palliative care is non-inferior to specialty palliative care with respect to caregiver depression symptoms measured by the Hospital Anxiety and Depression Scale (HADS).
Higher scores on HADS depression subscale (range 0-21) indicate greater depression symptoms.
Measured: Up to 12 Weeks
Caregiver Anxiety Symptoms
Assess whether primary palliative care is non-inferior to specialty palliative care with respect to caregiver anxiety symptoms measured by the Hospital Anxiety and Depression Scale (HADS).
Higher scores on HADS anxiety subscale (range 0-21) indicate greater anxiety symptoms.
Measured: Up to 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start1 Jun 2022
- Primary completionApr 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Adult AMLStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, El-Jawahri, Areej,M.D., Massachusetts General Hospital
- Investigators
- Areej El-Jawahri, MD, Principal investigator, Massachusetts General HospitalJennifer Temel, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237258
- Sponsor's protocol ID
- 21-646
- Acronym
- SCOPE-L
- Status last verified
- Jul 2025
- First submitted
- 2 Feb 2022
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.