Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia (SCOPE-L)

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).

Study Overview

• Status: Recruiting
• Conditions: High Risk Acute Myeloid Leukemia; Relapsed Adult AML; Primary Refractory Acute Myeloid Leukemia
• Intervention / Treatment: Behavioral: Specialty Palliative Care; Behavioral: Primary Palliative Care

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.

• Study Type: Interventional
• Enrollment (Estimated): 2300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Areej El-Jawahri, MD; Phone Number: 617-724-4000; Email: ael-jawahri@partners.org
• Study Contact Backup: Name: Chardria S Trotter, MPH, MBA; Email: CTrotter@mgh.harvard.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama - Birmingham
      • Contact: Richard Taylor, PhD; Email: rtaylor@uabmc.edu
      • Contact: Omer Jamy, MD; Email: omerjamy@uabmc.edu
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University
      • Contact: Karl Lorenz, MD; Email: kalorenz@stanford.edu
      • Contact: Gabriel Mannis, MD; Email: gmannis@stanford.edu
  • Colorado
    • Denver, Colorado, United States, 80204
      • Recruiting
      • University of Colorado Denver I Anschutz Medical Campus
      • Contact: Stacy Fischer, MD; Email: STACY.FISCHER@CUANSCHUTZ.EDU
      • Contact: Christine McMahon, MD; Email: CHRISTINE.MCMAHON@CUANSCHUTZ.EDU
  • Florida
    • Miami, Florida, United States, 33146
      • Recruiting
      • University of Miami
      • Contact: Lara Traeger, PhD; Email: ltraeger@miami.edu
      • Contact: Michael Huber, MD; Email: mth131@med.miami.edu
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffitt Cancer Center
      • Contact: Sara Tinsley-Vance, PhD; Email: Sara.TinsleyVance@moffitt.org
      • Contact: David Craig, PharmD; Email: David.Craig@moffitt.org
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University
      • Contact: Dio Kavalieratos, MD; Email: d.kavalieratos@emory.edu
      • Contact: Martha Arellano, MD; Email: marella@emory.edu
  • Illinois
    • Evanston, Illinois, United States, 60208
      • Recruiting
      • Northwestern University
      • Contact: Jessica Altman, MD; Email: jaltman@nm.org
      • Contact: Jayson Neagle, MD; Email: jayson.neagle@nm.org
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • Recruiting
      • Indiana University
      • Contact: Larry Cripe, MD; Email: lcripe@iu.edu
      • Contact: James Cleary, MD; Email: jfcleary@iu.edu
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Recruiting
      • Johns Hopkins University
      • Contact: Corey Tapper, MD; Email: ctapper1@jhmi.edu
      • Contact: B. Douglas Smith, MD; Email: bdsmith@jhmi.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Massachusetts General Hospital
      • Principal Investigator: Areej El-Jawahri, MD
      • Principal Investigator: Jennifer Temel, MD
      • Contact: Areej El-Jawahri, MD; Phone Number: 617-724-4000; Email: ael-jawahri@mgb.org
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
      • Contact: Oreofe Odejide, MD, MPH; Email: oreofe_odejide@dfci.harvard.edu
      • Contact: James Tulsky, MD; Email: jamesa_tulsky@dfci.harvard.edu
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Contact: Jacob Strand, MD; Email: strand.jacob@mayo.edu
      • Contact: Hassan Alkhateeb, MD; Email: alkhateeb.hassan@mayo.edu
  • New York
    • Rochester, New York, United States, 14627
      • Recruiting
      • University of Rochester
      • Contact: Kah Poh Loh, MD; Email: kahpoh_loh@urmc.rochester.edu
      • Contact: Paul Vermilion, MD; Email: Paul_Vermilion@URMC.Rochester.edu
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • University of North Carolina at Chapel Hill
      • Contact: Laura Hanson, MD, MPH; Email: laura_hanson@med.unc.edu
      • Contact: William Wood, Jr., MD; Email: william_wood@med.unc.edu
    • Durham, North Carolina, United States, 27708
      • Recruiting
      • Duke University
      • Contact: Thomas LeBlanc, MD; Email: thomas.leblanc@duke.edu
      • Contact: Wil Santivasi, MD; Email: wil.santivasi@duke.edu
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University
      • Contact: Erin Stevens, DO; Email: erin.stevens@osumc.edu
      • Contact: Alice Mims, MD; Email: Alice.Mims@osumc.edu
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University
      • Contact: Jason Webb, MD; Email: webbja@ohsu.edu
      • Contact: Rachel Cook, MD, MS; Email: coora@ohsu.edu
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Selina Luger, MD; Email: Selina.Luger@Pennmedicine.upenn.edu
      • Contact: Kathryn McGrath, MD; Email: Kathryn.Mcgrath@Pennmedicine.upenn.edu
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutchinson Cancer Center
      • Contact: Mohamed Sorror, MD, MSc; Email: msorror@fredhutch.org
      • Contact: James Fausto, PhD; Email: jfausto@uw.edu
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • Recruiting
      • University of Wisconsin
      • Contact: Priyanka Pophali, MD; Email: pophali@wisc.edu
      • Contact: Meaghan Trainor, MD; Email: mtrainor@medicine.wisc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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
  • 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.

Exclusion Criteria:

- 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Specialty Palliative Care; - Participants will complete baseline self-report assessments at the time of informed consent	Behavioral: Specialty Palliative Care; Participants assigned to specialty palliative care will be cared for by both oncology and palliative care clinicians during their hospital stays for AML.
Experimental: Primary Palliative Care; - Participants will complete baseline self-report assessments at the time of informed consent	Behavioral: Primary Palliative Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Last 30 days of life
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).	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.	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.	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.	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).	Up to 12 Weeks
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.	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.	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.	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.	Up to 12 Weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Prognostic Understanding	Compare patient prognostic understanding between those receiving primary palliative care and specialty palliative care based on the Prognostic Awareness Impact Scale (PAIS). The PAIS items that focus on the likelihood of cure will be used to compare prognostic understanding. Patients will report the likelihood of cure of their leukemia on a Likert's scale. Prognostic understanding will be dichotomized into likely cure versus. unlikely cure and compared between the two groups.	Up to 24 weeks
Patient Coping	Compare patient coping between those receiving primary palliative care versus specialty palliative care using the Brief Cope. Higher scores on the domains of the Brief Cope indicate higher use of coping strategies.	Up to 24 weeks
Hospitalization	Compare hospitalization in the last 30 days of life between those receiving primary palliative care versus specialty palliative care.	Last 30 days of life
Intensive Care Unit (ICU) Admissions	Compare intensive care unit admissions in the last 30 days of life between those receiving primary palliative care versus specialty palliative care.	Last 30 days of life
Hospice Utilization	Compare hospice utilization between those receiving primary palliative care versus specialty palliative care.	Last 30 days of life
Hospice Length of Stay	Compare hospice length of stay between those receiving primary palliative care versus specialty palliative care.	Last 30 days of life
Patient Symptom Burden	Compare patient symptom burden between those receiving primary palliative care versus specialty palliative care using the revised Edmonton Symptom Assessment Scale (ESAS-R). Higher scores on ESAS-R (range 0 - 100) indicate greater symptom burden.	Up to 24 weeks
Patient Perception of Care	Compare patients' perception of patient-centeredness of care between those receiving primary palliative care versus specialty palliative care using the Patient Perception of Patient-Centeredness of Care (PPPC). Higher scores indicate greater satisfaction with care.	Up to 24 weeks
Caregiver-Reported End-of-Life (EOL) Communication	Compare caregiver-reported end-of-life (EOL) communication between those receiving primary palliative care versus specialty palliative care 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).	Up to 24 weeks
Caregiver Prognostic Understanding	Compare caregiver prognostic understanding between those receiving primary palliative care versus specialty palliative care based on the Prognositic Awareness Impact Scale (PAIS). PAIS items that focus on likelihood of cure will be used to compare prognostic understanding.	Up to 24 weeks
Caregiver Coping	Compare caregiver coping between those receiving primary palliative care versus specialty palliative care using the Brief COPE. Higher scores on the domains of the Brief Cope indicate higher use of coping strategies.	Up to 24 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Areej El-Jawahri, MD, Massachusetts General Hospital; Principal Investigator: Jennifer Temel, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: February 2, 2022
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (Actual): February 14, 2022

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 22, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Caregivers; High Risk Acute Myeloid Leukemia; Relapsed Adult AML; Primary Refractory Acute Myeloid Leukemia
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: 21-646

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No