Hermioni L. Amonoo , Richard Newcomb , Karl A. Lorenz , Riley Psenka , Katherine Holmbeck , Emelia J. Farnam , Alexandra Tse , Sid Desai , Nik Vassev , Lauren P. Waldman , Areej El-Jawahri
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引用次数: 0
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.
期刊介绍:
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.