Cargando…

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

BACKGROUND: 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...

Descripción completa

Detalles Bibliográficos
Autores principales: King, Amanda L., Acquaye, Alvina A., Mendoza, Tito, Reyes, Jennifer, Stockdill, Macy, Gilbert, Mark R., Armstrong, Terri S., Vera, Elizabeth
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Journal Experts 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9980195/
https://www.ncbi.nlm.nih.gov/pubmed/36865245
http://dx.doi.org/10.21203/rs.3.rs-2521990/v1
_version_ 1784899866038632448
author King, Amanda L.
Acquaye, Alvina A.
Mendoza, Tito
Reyes, Jennifer
Stockdill, Macy
Gilbert, Mark R.
Armstrong, Terri S.
Vera, Elizabeth
author_facet King, Amanda L.
Acquaye, Alvina A.
Mendoza, Tito
Reyes, Jennifer
Stockdill, Macy
Gilbert, Mark R.
Armstrong, Terri S.
Vera, Elizabeth
author_sort King, Amanda L.
collection PubMed
description BACKGROUND: 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. METHODS: 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-minute 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. DISCUSSION: 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. TRIAL REGISTRATION: clinicaltrials.gov (NCT04301089), registered 9 March 2020
format Online
Article
Text
id pubmed-9980195
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher American Journal Experts
record_format MEDLINE/PubMed
spelling pubmed-99801952023-03-03 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 King, Amanda L. Acquaye, Alvina A. Mendoza, Tito Reyes, Jennifer Stockdill, Macy Gilbert, Mark R. Armstrong, Terri S. Vera, Elizabeth Res Sq Article BACKGROUND: 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. METHODS: 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-minute 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. DISCUSSION: 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. TRIAL REGISTRATION: clinicaltrials.gov (NCT04301089), registered 9 March 2020 American Journal Experts 2023-02-16 /pmc/articles/PMC9980195/ /pubmed/36865245 http://dx.doi.org/10.21203/rs.3.rs-2521990/v1 Text en https://creativecommons.org/licenses/by/4.0/This work is licensed under a Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/) , which allows reusers to distribute, remix, adapt, and build upon the material in any medium or format, so long as attribution is given to the creator. The license allows for commercial use.
spellingShingle Article
King, Amanda L.
Acquaye, Alvina A.
Mendoza, Tito
Reyes, Jennifer
Stockdill, Macy
Gilbert, Mark R.
Armstrong, Terri S.
Vera, Elizabeth
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9980195/
https://www.ncbi.nlm.nih.gov/pubmed/36865245
http://dx.doi.org/10.21203/rs.3.rs-2521990/v1
work_keys_str_mv AT kingamandal feasibilityandpreliminaryefficacyofavirtualrealityinterventiontargetingdistressandanxietyinprimarybraintumorpatientsatthetimeofclinicalevaluationstudyprotocolforaphase2clinicaltrial
AT acquayealvinaa feasibilityandpreliminaryefficacyofavirtualrealityinterventiontargetingdistressandanxietyinprimarybraintumorpatientsatthetimeofclinicalevaluationstudyprotocolforaphase2clinicaltrial
AT mendozatito feasibilityandpreliminaryefficacyofavirtualrealityinterventiontargetingdistressandanxietyinprimarybraintumorpatientsatthetimeofclinicalevaluationstudyprotocolforaphase2clinicaltrial
AT reyesjennifer feasibilityandpreliminaryefficacyofavirtualrealityinterventiontargetingdistressandanxietyinprimarybraintumorpatientsatthetimeofclinicalevaluationstudyprotocolforaphase2clinicaltrial
AT stockdillmacy feasibilityandpreliminaryefficacyofavirtualrealityinterventiontargetingdistressandanxietyinprimarybraintumorpatientsatthetimeofclinicalevaluationstudyprotocolforaphase2clinicaltrial
AT gilbertmarkr feasibilityandpreliminaryefficacyofavirtualrealityinterventiontargetingdistressandanxietyinprimarybraintumorpatientsatthetimeofclinicalevaluationstudyprotocolforaphase2clinicaltrial
AT armstrongterris feasibilityandpreliminaryefficacyofavirtualrealityinterventiontargetingdistressandanxietyinprimarybraintumorpatientsatthetimeofclinicalevaluationstudyprotocolforaphase2clinicaltrial
AT veraelizabeth feasibilityandpreliminaryefficacyofavirtualrealityinterventiontargetingdistressandanxietyinprimarybraintumorpatientsatthetimeofclinicalevaluationstudyprotocolforaphase2clinicaltrial