Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia

Relapsed Adult AML Clinical Trial

— SCOPE-L  

Official title:

Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05237258
• Other study ID #: 21-646
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: April 2029

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: Areej El-Jawahri, MD
• Phone: 617-724-4000
• Email: ael-jawahri[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2300
• Est. completion date: April 2029
• Est. primary completion date: April 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• High Risk Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Relapsed Adult AML

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama - Birmingham	Birmingham	Alabama
United States	Indiana University	Bloomington	Indiana
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Ohio State University	Columbus	Ohio
United States	University of Colorado Denver I Anschutz Medical Campus	Denver	Colorado
United States	Duke University	Durham	North Carolina
United States	Northwestern University	Evanston	Illinois
United States	University of Wisconsin	Madison	Wisconsin
United States	University of Miami	Miami	Florida
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester	Rochester	New York
United States	Fred Hutchinson Cancer Center	Seattle	Washington
United States	Stanford University	Stanford	California
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	Hospice Utilization	Compare hospice utilization between those receiving primary palliative care versus specialty palliative care.	Last 30 days of life
Other	Hospice Length of Stay	Compare hospice length of stay between those receiving primary palliative care versus specialty palliative care.	Last 30 days of life
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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 24 Weeks
Secondary	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 24 Weeks
Secondary	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 24 Weeks
Secondary	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 24 Weeks
Secondary	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 24 Weeks
Secondary	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
Secondary	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 24 Weeks
Secondary	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 24 Weeks
Secondary	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.	Baseline and Weeks: 2, 4, 12, and 24
Secondary	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 24 Weeks