Evidence map›Paper›PMID 36944930›Full record

ArticleBMC cancer2023

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.

Amanda L King, Alvina A Acquaye-Mallory, Elizabeth Vera, Tito Mendoza, Jennifer Reyes, Macy L Stockdill, Mark R Gilbert, Terri S Armstrong

Registry-linked trialOpen access · goldFull text readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04301089 (A Phase II Feasibility Trial Using Immersive Virtual Reality), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.7field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04301089 phase2completednot on this map

A Phase II Feasibility Trial Using Immersive Virtual Reality (VR) at the Time of Clinical Evaluation to Improve Psychological Distress and Anxiety in Primary Brain Tumor (PBT) Patients

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2021 to 2025Enrolled61ConditionsAnxietyArmsPico G2 4K Headset with Applied VR software, Patient Reported Questionnaires, Saliva sample collection (hormones)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Amanda L KingNeuro-Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, 20892, USA. amanda.king2@nih.gov.
Alvina A Acquaye-MalloryNeuro-Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, 20892, USA.
Elizabeth VeraNeuro-Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, 20892, USA.
Tito MendozaNeuro-Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, 20892, USA.
Jennifer ReyesNeuro-Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, 20892, USA.
Macy L StockdillNeuro-Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, 20892, USA.
Mark R GilbertNeuro-Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, 20892, USA.
Terri S ArmstrongNeuro-Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, 20892, USA.
National Institutes of Health · USNational Cancer Institute · US

Funding

Implementation of telehealth and health technology to improve patient outcomesZIABC012073 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI ARMSTRONG, TERRI S. · 2022 to 2024
$2.1M
6 · The paper itself

Abstract

backgroundPrimary 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.

methodsPBT 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. 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 registrationClinicaltrials.gov (NCT04301089), registered 9 March 2020.

Indexed as

Brain NeoplasmsVirtual Reality Exposure TherapyAnxietyAnxiety DisordersClinical Trials, Phase II as TopicFeasibility StudiesHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicAnxietyDistressPrimary brain tumorVirtual reality

Identifiers

PMID36944930
PMCPMC10030076
OpenAlexW4353016772

What OpenQuestion holds

Textfull text, public
LicenceCC BY
measurements read12
identifiers read1
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.