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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05237258

Collaborator

Patient-Centered Outcomes Research Institute (Other)

2,300

Enrollment

Locations

Arms

Anticipated Duration (Months)

575

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Anticipated 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 :

Jun 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2028

Anticipated Study Completion Date :

Apr 1, 2029

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Quality of Life (QOL) [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

Patient Quality of Life (QOL) [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).
Patient Depression Symptoms [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.
Patient Anxiety Symptoms [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.
Patient Post-Traumatic Stress Disorder (PTSD) Symptoms [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.
End-of-Life (EOL) Communication [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).
End-of-Life (EOL) Care [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.
Caregiver Quality of Life (QOL) [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.
Caregiver Burden [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.
Caregiver Depression Symptoms [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.
Caregiver Anxiety Symptoms [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

Patient Prognostic Understanding [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.
Patient Coping [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.
Hospitalization [Last 30 days of life]
Compare hospitalization in the last 30 days of life between those receiving primary palliative care versus specialty palliative care.
Intensive Care Unit (ICU) Admissions [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.
Hospice Utilization [Last 30 days of life]
Compare hospice utilization between those receiving primary palliative care versus specialty palliative care.
Hospice Length of Stay [Last 30 days of life]
Compare hospice length of stay between those receiving primary palliative care versus specialty palliative care.
Patient Symptom Burden [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.
Patient Perception of Care [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.
Caregiver-Reported End-of-Life (EOL) Communication [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).
Caregiver Prognostic Understanding [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.
Caregiver Coping [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02115
2	Mayo Clinic	Rochester	Minnesota	United States	55905
3	Duke University	Durham	North Carolina	United States	27708
4	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104