Relapsed Adult AML Clinical Trial
— SCOPE-LOfficial title:
Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia
NCT number | NCT05237258 |
Other study ID # | 21-646 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2022 |
Est. completion date | April 2029 |
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).
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Patient-Centered Outcomes Research Institute |
United States,
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 |
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