Randomized Trial of Inpatient Palliative Care for Patients with Hematologic Malignancies Undergoing Hematopoietic Stem Cell Transplantation

Overview: The goal of this study is to demonstrate the efficacy of inpatient palliative care integrated with transplant care for improving quality of life (QOL) and mood of patients with hematological malignancies undergoing hematopoietic stem cell transplantation (HCT) and their caregivers. Background: Patients undergoing HCT endure an immense physical and psychological symptom burden during their 3-4 week transplant hospitalization with 50-70% reporting moderate to severe nausea, fatigue, diarrhea, and pain, and over 40% reporting significant depression and anxiety symptoms. Importantly, patients' QOL deterioration during HCT predicts their QOL and psychological distress post-HCT. Caregivers (i.e. family and friends) of patients undergoing HCT also struggle emotionally during and after their loved one's transplant. Despite the burden experienced by these individuals, interventions are lacking to improve their QOL and care. We completed a single center randomized trial of inpatient integrated palliative and transplant care in patients undergoing HCT and demonstrated clinically significant improvements in patients' QOL, symptom burden, depression, and anxiety during HCT. Notably, the effects of the intervention were sustained three and six months postHCT with improvement in patients' depression and post-traumatic stress symptoms. Caregivers of patients randomized to the intervention reported improvements in their coping and depression. Thus, this is the first trial to establish both the feasibility and preliminary efficacy of inpatient integrated palliative and transplant care in improving outcomes of patients with hematologic malignancies and their caregivers. Research Plan: We propose to conduct a multi-site randomized trial of inpatient integrated palliative and transplant care versus transplant care alone in patients with hematologic malignancies undergoing HCT. The primary goal of this study is to demonstrate definitively the efficacy of inpatient palliative care for improving patient and caregiver reported outcomes in a multi-site trial with a large and more diverse patient population. We will also assess the impact of the palliative care intervention on participant-reported QOL and psychological outcomes post-HCT. Lastly, we will explore potential mediators and moderators of the inpatient integrated palliative and transplant care model on patient-reported QOL. Environment: This project will be conducted at Massachusetts General Hospital, Fred Hutchinson Cancer Research Center, and the University of Miami. These sites have the palliative care and transplant experience, infrastructure, and processes to conduct this trial. The MGH research team has the expertise in developing and testing integrated palliative care models for patients with solid tumors and hematologic malignancies to ensure the successful implementation and evaluation of the palliative care intervention across study sites. Relevance of Research: This project will establish the essential foundation of a future implementation and dissemination trial of inpatient integrated palliative and transplant care for patients undergoing HCT.