Feasibility and preliminary efficacy of a virtual reality intervention targeting distress and anxiety in primary brain tumor patients at the time of clinical evaluation: Study protocol for a phase 2 clinical trial

Primary brain tumor (PBT) patients experience higher levels of distress and anxiety than other solid tumor patients, particularly at the time of clinical evaluation when uncertainty about disease status is high ("scanxiety"). There is promising evidence supporting use of virtual reality (V...

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Bibliographic Details
Published in:	BMC cancer 2023-03, Vol.23 (1), p.262-262, Article 262
Main Authors:	King, Amanda L, Acquaye-Mallory, Alvina A, Vera, Elizabeth, Mendoza, Tito, Reyes, Jennifer, Stockdill, Macy L, Gilbert, Mark R, Armstrong, Terri S
Format:	Article
Language:	eng
Subjects:	Anxiety Anxiety - etiology Anxiety - therapy Anxiety Disorders Brain cancer Brain Neoplasms - therapy Brain research Brain tumors Care and treatment Clinical trials Clinical Trials, Phase II as Topic Computer applications Coronaviruses COVID-19 Diagnosis Distress Evaluation Feasibility Studies Health aspects Humans Intervention Loneliness Multicenter Studies as Topic Oncology Pandemics Patient satisfaction Pediatrics Primary brain tumor Psychological aspects Randomized Controlled Trials as Topic Social distancing Solid tumors Steroids Stress (Psychology) Study Protocol Telemedicine Tumors Virtual reality Virtual Reality Exposure Therapy - methods
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Summary:	Primary brain tumor (PBT) patients experience higher levels of distress and anxiety than other solid tumor patients, particularly at the time of clinical evaluation when uncertainty about disease status is high ("scanxiety"). There is promising evidence supporting use of virtual reality (VR) to target psychological symptoms in other solid tumor patients, though PBT patients have not been studied extensively in this context. The primary aim of this phase 2 clinical trial is to establish the feasibility of a remote VR-based relaxation intervention for a PBT population, with secondary aims designed to determine preliminary efficacy of improving distress and anxiety symptoms. PBT patients (N = 120) with upcoming MRI scans and clinical appointments who meet eligibility will be recruited to participate in a single arm trial conducted remotely through the NIH. Following completion of baseline assessments, participants will complete a 5-min VR intervention via telehealth using a head-mounted immersive device while under supervision of the research team. Following the intervention, over the course of 1 month patients can use VR at their discretion with follow-up assessments done immediately post-VR intervention, as well as 1 week and 4 weeks later. Additionally, a qualitative phone interview will be conducted to assess patient satisfaction with the intervention. Use of immersive VR is an innovative interventional approach to target distress and scanxiety symptoms in PBT patients who are at high risk for experiencing these symptoms leading into their clinical appointments. Findings from this study may inform design of a future multicenter randomized VR trial for PBT patients and may aid in development of similar interventions for other oncology populations. Clinicaltrials.gov (NCT04301089), registered 9 March 2020.
ISSN:	1471-2407 1471-2407