Multi-Site Randomized Trial of Inpatient Palliative Care for Hospitalized Patients Undergoing Hematopoietic Stem Cell Transplantation
Authors: El-Jawahri Areej , LeBlanc Thomas W , Kavanaugh Alison , Webb Jason , Fausto James , Traeger Lara , Greer Joseph , Jackson Vicki , Horick Nora , Defilipp Zachariah , Chen Yi-Bin , Lee Stephanie J. , Temel Jennifer 
Published: December 2023

Background: Patients with hematologic malignancies experience a substantial decline in their quality of life (QOL) and psychological health during their hospitalization for hematopoietic stem cell transplantation (HSCT). Early single center studies established the feasibility and promising preliminary efficacy of integrating palliative care during the HSCT hospitalization. However, data to test the efficacy of this care model across diverse care settings are lacking.

Methods: We conducted a multi-site randomized trial among 360 adults with hematologic malignancies undergoing autologous or allogeneic HSCT at three academic institutions. Patients were randomly assigned to an inpatient palliative care intervention (n= 180) versus usual care (n=180), stratified by study site and type of HSCT. Intervention participants met with a palliative care clinician at least twice weekly during the HSCT hospitalization to address their physical and psychological symptoms. Patients assigned to usual care received all supportive care measures provided by the HSCT team and could be seen by palliative care upon request. We assessed patient QOL (Functional Assessment of Cancer Therapy (FACT) - Bone Marrow Transplant), depression and anxiety symptoms (Hospital Anxiety and Depression Scale), post-traumatic stress (PTSD) symptoms (PTSD Checklist), symptom burden (Edmonton Symptom Assessment Scale-Revised), and fatigue (FACT-Fatigue, higher scores indicate lower fatigue) at baseline and week-2 during hospitalization. The primary endpoint was QOL at week-2 during the HSCT hospitalization when patients typically experience their QOL nadir during HSCT. We used analysis of covariance, adjusting for baseline scores, to evaluate the effect of the intervention on patient-reported outcomes at week-2.

Results: We enrolled 69.5% (360/518) of eligible patients (mean age = 55.4 (SD=12.5), 61.9% male, 76.6% White, 23.4% racial minorities, 8.7% Hispanic ethnicity, and 50.2% underwent allogeneic HSCT) between October 2018 and July 2022. Compared to those receiving usual care, participants receiving the inpatient palliative care intervention reported better QOL (95.5 vs. 89.3, P&lt;0.001), and lower depression (5.9 vs. 6.9, P=0.041) and PTSD symptoms (26.0 vs. 28.2, P = 0.022) at week-2. Intervention participants also reported lower symptom burden (35.3 vs. 40.1, P=0.018) and better fatigue scores (28.6 vs. 25.6, p=0.014) compared to those assigned to usual care at week-2 during HSCT hospitalization. Anxiety symptoms (HADS-A) did not demonstrate a measurable difference between the two groups at week-2 during HSCT.

Conclusions: In this multi-site randomized clinical trial, inpatient palliative care led to substantial improvements in patients' QOL, depression and PTSD symptoms, symptom burden, and fatigue during HSCT hospitalization compared to usual care. Integrated palliative care should be considered a new standard of care for patients hospitalized for HSCT.