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Contemp Clin Trials ; 142: 107550, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38685401

ABSTRACT

BACKGROUND: Although patients undergoing hematopoietic stem cell transplantation (HSCT) must cope with psychological distress and isolation during an extended transplant hospitalization, psychosocial interventions to address these unmet needs are lacking. Virtual reality offers an innovative modality to deliver a patient-centered psychosocial intervention to address psychosocial needs of patients undergoing HSCT. However, there are currently no supportive care interventions leveraging virtual reality in patients undergoing HSCT. OBJECTIVE: To describe the methods of a randomized clinical trial (RCT) to assess the feasibility and preliminary efficacy of a self-administered, virtual reality-delivered psychosocial intervention (BMT-VR) to improve psychological distress and quality of life (QOL) for patients hospitalized for HSCT. METHODS: This study entails a single-center RCT of BMT-VR compared to usual transplant care in 80 patients hospitalized for HSCT. Adult patients with hematologic malignancies hospitalized for autologous or allogeneic HSCT are eligible. BMT-VR includes psychoeducation about the HSCT process, psychosocial skill building to promote effective coping and acceptance, and self-care and positive psychology skills to promote post-HSCT recovery. The primary aim is to assess the feasibility defined a priori as ≥60% of eligible patients enrolling in the study, and of those enrolled and randomized to the BMT-VR, ≥ 60% completing 4/6 BMT-VR modules. Secondary objectives include assessing the preliminary effects on psychological distress and QOL. DISCUSSION: This is the first RCT of a virtual reality-delivered psychosocial intervention for the HSCT population. If deemed feasible, a future larger multi-site clinical trial can evaluate the efficacy of BMT-VR on outcomes for patients hospitalized for HSCT.


Subject(s)
Hematopoietic Stem Cell Transplantation , Quality of Life , Adult , Female , Humans , Male , Adaptation, Psychological , Feasibility Studies , Hematologic Neoplasms/therapy , Hematologic Neoplasms/psychology , Hematopoietic Stem Cell Transplantation/psychology , Hematopoietic Stem Cell Transplantation/methods , Hospitalization , Patient Education as Topic/methods , Pilot Projects , Psychological Distress , Psychosocial Intervention/methods , Self Care/methods , Stress, Psychological/therapy , Virtual Reality
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