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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05237258
Recruitment Status : Recruiting
First Posted : February 14, 2022
Last Update Posted : March 13, 2024
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
El-Jawahri, Areej,M.D., Massachusetts General Hospital

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).

Condition or disease Intervention/treatment Phase
Relapsed Adult AML Primary Refractory Acute Myeloid Leukemia High Risk Acute Myeloid Leukemia Behavioral: Specialty Palliative Care Behavioral: Primary Palliative Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia
Actual Study Start Date : June 1, 2022
Estimated Primary Completion Date : April 2028
Estimated Study Completion Date : April 2029


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.




Primary Outcome Measures :
  1. Quality of Life (QOL) [ Time Frame: Over 12 weeks ]

    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.



Secondary Outcome Measures :
  1. Patient Quality of Life (QOL) [ Time Frame: Up to 24 Weeks ]
    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).

  2. Patient Depression Symptoms [ Time Frame: Up to 24 Weeks ]

    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.


  3. Patient Anxiety Symptoms [ Time Frame: Up to 24 Weeks ]

    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.


  4. Patient Post-Traumatic Stress Disorder (PTSD) Symptoms [ Time Frame: Up to 24 Weeks ]

    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.


  5. End-of-Life (EOL) Communication [ Time Frame: Up to 24 Weeks ]

    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).


  6. End-of-Life (EOL) Care [ Time Frame: Last 30 days of life ]
    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.

  7. Caregiver Quality of Life (QOL) [ Time Frame: Up to 24 Weeks ]

    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.


  8. Caregiver Burden [ Time Frame: Up to 24 Weeks ]

    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.


  9. Caregiver Depression Symptoms [ Time Frame: Baseline and Weeks: 2, 4, 12, and 24 ]

    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.


  10. Caregiver Anxiety Symptoms [ Time Frame: Up to 24 Weeks ]

    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.



Other Outcome Measures:
  1. Patient Prognostic Understanding [ Time Frame: Up to 24 weeks ]
    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.

  2. Patient Coping [ Time Frame: Up to 24 weeks ]
    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.

  3. Hospitalization [ Time Frame: Last 30 days of life ]
    Compare hospitalization in the last 30 days of life between those receiving primary palliative care versus specialty palliative care.

  4. Intensive Care Unit (ICU) Admissions [ Time Frame: Last 30 days of life ]
    Compare intensive care unit admissions in the last 30 days of life between those receiving primary palliative care versus specialty palliative care.

  5. Hospice Utilization [ Time Frame: Last 30 days of life ]
    Compare hospice utilization between those receiving primary palliative care versus specialty palliative care.

  6. Hospice Length of Stay [ Time Frame: Last 30 days of life ]
    Compare hospice length of stay between those receiving primary palliative care versus specialty palliative care.

  7. Patient Symptom Burden [ Time Frame: Up to 24 weeks ]

    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.


  8. Patient Perception of Care [ Time Frame: Up to 24 weeks ]

    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.


  9. Caregiver-Reported End-of-Life (EOL) Communication [ Time Frame: Up to 24 weeks ]
    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).

  10. Caregiver Prognostic Understanding [ Time Frame: Up to 24 weeks ]
    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.

  11. Caregiver Coping [ Time Frame: Up to 24 weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
    • 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
  • 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 or APP] during two previous hospitalizations in the six months prior to enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05237258


Contacts
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Contact: Areej El-Jawahri, MD 617-724-4000 ael-jawahri@partners.org
Contact: Porsha L Lark, MS, MPH PLark@mgh.harvard.edu

Locations
Show Show 20 study locations
Sponsors and Collaborators
Massachusetts General Hospital
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Areej El-Jawahri, MD Massachusetts General Hospital
Principal Investigator: Jennifer Temel, MD Massachusetts General Hospital
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Responsible Party: El-Jawahri, Areej,M.D., Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT05237258    
Other Study ID Numbers: 21-646
First Posted: February 14, 2022    Key Record Dates
Last Update Posted: March 13, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by El-Jawahri, Areej,M.D., Massachusetts General Hospital:
Relapsed Adult AML
Primary Refractory Acute Myeloid Leukemia
High Risk Acute Myeloid Leukemia
Caregivers
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Hematologic Diseases