Phase 2 Study Comparing Home Care Versus Hospital and Clinic Care After Autologous Hematopoietic Stem Cell Transplantation

What this Trial Is About

This research aims to compare the well-being of caregivers of patients undergoing autologous hematopoietic stem cell transplant by evaluating different care settings after transplant. The study focuses on measuring caregiver strain using the Caregiver Strain Index and other quality of life and mental health assessments. It is a randomized Phase 2 trial sponsored by Duke University, involving adult patients and their caregivers. Participants are assigned to one of three groups home care where transplant aftercare is provided in the patients home, hospital care with aftercare in the hospital, and clinic care with outpatient clinic aftercare. The study evaluates the impact of these care models on caregiver outcomes over various timeframes, including 14 days for the primary outcome and up to one year for secondary outcomes. The trial also includes monitoring of patient survival, infection rates, hospital admissions, and treatment-related effects. Participants will engage in assessments such as caregiver strain questionnaires, time diaries, self-efficacy scales, fatigue and mental health measures, quality of life surveys, and physical function tests. Data collection occurs at multiple timepoints up to one year, including tracking of costs and health resource use. Researchers will also evaluate biological samples like fecal and skin microbiome changes. Safety and treatment effects are monitored throughout with follow-ups extending to one year post-transplant.

A Phase 2 Study of Home Care Following Autologous Hematopoietic Stem Cell Transplantation