This phase II trial investigates the effect of palliative care on patients with acute myeloid leukemia, acute lymphoblastic leukemia, high-risk myelodysplastic syndrome or high risk chronic myelomonocytic leukemia that is newly diagnosed, has come back (relapsed), or does not respond to treatment (refractory). Providing earlier palliative care may help to decrease the death in intensive care unit.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04482894.
PRIMARY OBJECTIVE:
I. To estimate the difference in the proportion of relapsed, refractory, high-risk leukemia and high risk myelodysplastic syndrome patients who die in the intensive care unit (ICU) for patients who receive early and continued palliative care (PC) consultation versus patients who receive standard of care.
SECONDARY OBJECTIVES:
I. To obtain estimates of the difference in the effect of early and continued PC consultation compared to standard of care on overall survival, length of stay in the hospital, length of stay in the ICU, frequency of emergency department (ED) visits, the use of hospice services, transfusion support, quality of life, advanced care planning.
II. Investigate the impact of sociodemographic factors such as race, ethnicity and area of residence on end of life care.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Inpatients meet with PC specialists within 3 days of enrollment followed by twice weekly visits. Outpatients meet with PC specialists within 14 days of enrollment followed by at least once every two weeks or matched to the frequency of scheduled oncology visits.
ARM B: Patients receive standard of care and PC consults at the discretion of their treating team.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationUniversity of Virginia Cancer Center
Principal InvestigatorKaren Kuhn Ballen