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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-120
SponsorMassachusetts General Hospital

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patient Inclusion Criteria

Patients with new diagnosis ≥ 60 years of age

An antecedent hematologic disorder

Therapy related-disease

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Specialty Palliative Care

    Behavioral

    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

    Behavioral

    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.

Treatment groups

2,300 Participants
are divided into 2 treatment groups
Group A: Specialty Palliative CareExperimental treatment 1 intervention
Group B: Primary Palliative CareExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Over 12 weeks

Secondary outcomes

1

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).

Time frame
Up to 2 Weeks
2

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.

Time frame
Up to 12 Weeks
3

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.

Time frame
Up to 12 Weeks
4

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.

Time frame
Up to 12 Weeks

Other outcomes

1

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.

Time frame
Up to 24 weeks
2

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.

Time frame
Up to 24 weeks
3

Hospitalization

Compare hospitalization in the last 30 days of life between those receiving primary palliative care versus specialty palliative care.

Time frame
Last 30 days of life
4

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.

Time frame
Last 30 days of life

Sponsors and contacts

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Massachusetts General Hospital

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator