Protocol for multi-site randomized trial of inpatient palliative care for patients with hematologic malignancies undergoing hematopoietic stem cell transplantation

Patients with hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT) commonly experience debilitating physical and psychological symptoms during a 3–4-week-hospitalization. During hospitalization, caregivers (i.e., family and friends) also endure immense emotional stress...

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Bibliographic Details
Published in:Contemporary clinical trials 2024-03, Vol.138, p.107460-107460, Article 107460
Main Authors: Yang, Daniel, Newcomb, Richard, Kavanaugh, Alison R., Khalil, Dania, Greer, Joseph A., Chen, Yi-Bin, DeFilipp, Zachariah, Temel, Jennifer, Lee, Stephanie J., LeBlanc, Thomas W., El-Jawahri, Areej
Format: Article
Language:English
Subjects:
Fatigue - etiology
Fatigue - therapy
Hematologic Neoplasms - therapy
Hematopoietic Stem Cell Transplantation
Hospitalization
Humans
Inpatients
Multicenter Studies as Topic
Palliative care
Palliative Care - methods
Quality of life
Quality of Life - psychology
Randomized Controlled Trials as Topic
Stem cell transplant
Supportive oncology
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Summary:Patients with hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT) commonly experience debilitating physical and psychological symptoms during a 3–4-week-hospitalization. During hospitalization, caregivers (i.e., family and friends) also endure immense emotional stress as they witness their loved one struggle with HSCT toxicities. Yet interventions to improve quality of life (QOL) and reduce psychological distress during HSCT are limited. We are conducting a multi-site randomized controlled trial of inpatient integrated palliative and transplant care versus usual care in 360 patients hospitalized for HSCT and their caregivers at three academic centers. Intervention participants meet 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 receive all supportive care measures provided by the HSCT team and could be seen by palliative care upon request. We assess 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), and fatigue (FACT-Fatigue) as well as caregiver-reported outcomes at baseline, 2 weeks, 3-months, 6-months, and 12-months post-HSCT. The primary endpoint is to compare QOL at week-2 during HSCT hospitalization between the two groups when patients typically experience their QOL nadir during HSCT. This multi-site trial will define the role of palliative care for improving QOL and care for patients with hematologic malignancies undergoing HSCT and their caregivers. •This protocol describes the first multi-site randomized trial of palliative care integration in hematopoietic cell transplantation.•This trial will assess the efficacy of inpatient integrated palliative care for improving quality of life and psychological distress.•This trial will explore mediators of the effect of the palliative care intervention on patient-reported quality of life.
ISSN:1551-7144
1559-2030
DOI:10.1016/j.cct.2024.107460