NCT05237258 Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia
| NCT ID | NCT05237258 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Relapsed Adult AML |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,300 participants |
| Start Date | 2022-06-01 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,300 participants in total. It began in 2022-06-01 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility 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 * Within five business days of initiating therapy 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, DO, APP) during two previous hospitalizations in the six months prior to enrollment * Patients expected to be discharged within 2 days
Contact & Investigator
Areej El-Jawahri, MD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT05237258 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 120 Years, studying Relapsed Adult AML. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05237258 currently recruiting?
Yes, NCT05237258 is actively recruiting participants. Contact the research team at ael-jawahri@partners.org for enrollment information.
Where is the NCT05237258 trial being conducted?
This trial is being conducted at Birmingham, United States, Stanford, United States, Denver, United States, Miami, United States and 11 additional locations.
Who is sponsoring the NCT05237258 clinical trial?
NCT05237258 is sponsored by Massachusetts General Hospital. The principal investigator is Areej El-Jawahri, MD at Massachusetts General Hospital. The trial plans to enroll 2,300 participants.