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913 Multi-Site Randomized Trial of Inpatient Palliative Care for Hospitalized Patients Undergoing Hematopoietic Stem Cell Transplantation

Program: Oral and Poster Abstracts
Type: Oral
Session: 906. Outcomes Research – Myeloid Malignancies: Symptom Burden and Supportive Therapies
Hematology Disease Topics & Pathways:
Research, adult, Clinical Research, health outcomes research, patient-reported outcomes, Study Population, Human
Monday, December 11, 2023: 2:45 PM

Areej El-Jawahri, MD1, Thomas W LeBlanc, MD2, Alison Kavanaugh3*, Jason Webb, MD4*, James Fausto5*, Lara Traeger3*, Joseph Greer, PhD3*, Vicki Jackson, MD3*, Nora Horick6*, Zachariah Defilipp, MD7, Yi-Bin Chen, MD, MS3, Stephanie J. Lee8 and Jennifer Temel3*

1Massachusetts General Hospital, Allston, MA
2Division of Hematologic Malignancies and Cellular Therapy, Duke University School of Medicine, Durham, NC
3Massachusetts General Hospital, Boston, MA
4Oregon Health and Sciences University, Portland, OR
5Fred Hutchinson Cancer Research Center, Seattle, WA
6Massachusetts General Hospital, Boston
7Hematopoietic Cell Transplant and Cellular Therapy Program, Massachusetts General Hospital, Boston, MA
8Fred Hutchinson Cancer Center, Seattle, WA

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<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.

Disclosures: El-Jawahri: GSK: Consultancy; Incyte Corporation: Consultancy; Novartis: Consultancy. LeBlanc: Meter Health: Consultancy, Honoraria; GSK: Consultancy, Honoraria, Research Funding; BlueNote: Consultancy, Honoraria; BeiGene: Consultancy, Honoraria; BMS/Celgene: Consultancy, Honoraria, Research Funding, Speakers Bureau; Pfizer: Consultancy, Honoraria; Dosentrx: Current equity holder in private company; Incyte: Honoraria, Speakers Bureau; CareVive: Consultancy, Honoraria; Genentech: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Flatiron: Consultancy, Honoraria; Lilly: Consultancy, Honoraria; UpToDate: Patents & Royalties; AstraZeneca: Consultancy, Honoraria, Research Funding; Astellas: Consultancy, Honoraria, Speakers Bureau; Leukemia and Lymphoma Society: Research Funding; Jazz Pharmaceuticals: Research Funding; Deverra Therapeutics: Research Funding; Duke University: Research Funding; American Cancer Society: Research Funding; Agios: Consultancy, Honoraria, Speakers Bureau; Agilix: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria, Research Funding, Speakers Bureau; National Institute of Nursing Research/National Institutes of Health: Research Funding; Seattle Genetics: Research Funding; Servier: Consultancy, Honoraria. Defilipp: Regimmune: Research Funding; Incyte: Consultancy, Research Funding; Taiho Oncology: Research Funding; Sanofi: Consultancy; MorphoSys: Consultancy; Inhibrx: Consultancy; PharmaBiome AG: Consultancy; Ono Pharmaceutical: Consultancy.

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