Grant Number:	1R01CA282182-01A1 Interpret this number
Primary Investigator:	El-Jawahri, Areej
Organization:	Massachusetts General Hospital
Project Title:	BMT-CARE: Multimodal Psychosocial Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation
Fiscal Year:	2024

PROJECT SUMMARY/ABSTRACT Overview: The goal of this study is to demonstrate the efficacy of a cognitive-behaviorally based psychosocial intervention (BMT-CARE) compared to usual care for caregivers of patients undergoing hematopoietic stem cell transplantation (HCT) and to identify critical facilitators and barriers for intervention implementation and adoption. Background: Family and friend caregivers of patients undergoing HCT experience substantial distress before HCT as they cope with the uncertainty of the patient’s prognosis, and the patient endures significant toxicities. Additionally, as the primary caregivers of patients during the immediate post-HCT course, caregivers often man- age a demanding schedule of appointments and experience substantial caregiving burden interfering with their personal lives and responsibilities. Since these individuals experience intense and specialized caregiving burden which persists before, during, and for several months after HCT, there is a critical need to develop a population- specific intervention to address their needs across the transplant continuum. However, scalable interventions to support caregivers throughout the patients’ HCT course are lacking. We completed a single center pilot trial of BMT-CARE to address the needs of caregivers prior to, during, and after HCT, which entailed six one-hour visits with a trained study therapist during the HCT course. We demonstrated that the intervention was feasible and preliminarily led to clinically significant improvement in caregivers’ quality of life, mood, caregiving burden, self- efficacy, and coping skills. Thus, this was the first trial to establish both the feasibility and preliminary efficacy of BMT-CARE for improving outcomes of caregivers of HCT recipients. Research Plan: We propose to conduct a hybrid type I multi-site randomized effectiveness-implementation trial in 400 caregiver-patient dyads undergoing HCT to test the efficacy of BMT-CARE vs. usual care for improving caregiver QOL, caregiving burden, mood, coping, and self-efficacy. We will also examine the impact of BMT- CARE on patient-reported outcomes and health care utilization. Finally, we will identify critical facilitators and barriers for BMT-CARE implementation and adoption using the RE-AIM QuEST mixed-methods framework. Environment: This project will be conducted at the Massachusetts General Hospital (MGH), University of Ala- bama at Birmingham, and Moffitt Cancer Center, which collectively conduct 350-400 transplants per year. These sites have the supportive oncology research expertise and infrastructure, transplant experience, and processes to conduct this trial. The MGH research team has the expertise in developing and testing multi-site palliative and supportive care interventions for patients with hematologic malignancies and their caregivers to ensure the suc- cessful implementation and evaluation of BMT-CARE across study sites. Relevance of Research: This project will establish the essential foundation for a future implementation and dissemination trial of BMT-CARE into clinical practice.





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