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

NCT04301089 | Completed Phase 2 Results

• 2 other identifiers: 20006520-C-0065
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Distress, anxiety, and other psychological disorders may be more common in people with primary brain tumors (PBTs). PBTs can affect their symptoms, quality of life, and their tolerance of cancer treatments. Researchers want to learn if virtual reality (VR) technology can help reduce stress and improve mood. VR uses computer technology to make fake experiences and environments that look real. This allows people to escape from their lives and experience more positive thoughts and emotions. Objective: To learn if it is feasible to use a VR relaxation intervention in people with PBTs. Eligibility: Adults 18 and older who have a brain tumor and have recently reported psychological distress during their participation in the Natural History Study (NHS), protocol #16C0151 Design: The VR intervention and all patient-reported outcome measures (PROs) will be done remotely using telehealth. Participants will be mailed a VR headset. This headset looks like a thick pair of goggles that is worn over the eyes. Participants will view computer-generated environments on this VR headset. Participants will fill out symptom questionnaires at 4 different times points during participation in this study, including questionnaires for the NHS as well as 4 questionnaires unique to this study. There are also optional saliva samples that are collected at 2 of the timepoints. The 4 timepoints are:

• Baseline (before the VR intervention)
• Immediate post-VR (right after the VR intervention)
• 1 week later
• 4 weeks later Participants will also have a phone interview 4 weeks after the initial VR intervention, which will last 10 to 15 minutes. Participation lasts 4 to 6 weeks.

Conditions

Anxiety

Keywords

Virtual Reality; Scanxiety; Distress; Brain Tumors

Outcome Measures

Primary Outcomes (4)

• Number of Participants Who Completed Patient-Reported Outcomes (PROs) Questionnaires

  To report the feasibility of implementing a virtual reality (VR) intervention in a Primary Brain Tumor (PBT) population, the number of participants who completed the National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT), Spielberger State-Trait Anxiety Inventory, 6-item Short-Form (STAI-6), Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE), MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT), Was It Worth It (WIWI), Patient-Reported Outcomes Measurement Information System (PROMIS)-Emotional Distress-Anxiety and -Emotional Distress-Depression, and EuroQol 5 Dimensions 3 Level (EQ-5D-3L) questionnaires will be reported.

  Baseline, immediate post-use VR (within 1 hour), 1-week post-use VR (+/- 3 days), and/or 1-month post-use VR (+/- 7 days)

• Number of Participants Compliant With Virtual Reality (VR) Headset Use

  Participants are fitted with a Pico G2 4K headset and instructed by trained Research staff how to put on the headset, adjust the headset, navigate the main virtual interface, select different scenarios and proper use of the remote for the first time. If a participant was able to do the above, then they are compliant for the timepoint.

  Baseline, immediate post-use VR (within 1 hour), 1-week post-use VR (+/- 3 days), and/or 1-month post-use VR (+/- 7 days).

• Proportion of Eligible Participants Approached to be Screened for Study Eligibility Prior to Enrollment Who Enrolled in the Virtual Reality (VR) Intervention Study

  The proportion of eligible participants contacted by phone or email to participate in the study who enrolled in the virtual reality (VR) intervention study.

  Screening, up to 6 months prior to study enrollment.

• Proportion of Participants Who Reported Symptoms Measured by the Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire

  PRO-CTCAE measures symptomatic toxicities on a 5-point scale. Each symptomatic toxicity may have up to 3 attributes: frequency, severity, and interference. Higher ratings indicate more frequency, severity, or interference. The symptomatic toxicities chosen were nausea, vomiting, dizziness, and headache.

  Baseline, immediate post-use virtual reality (VR (within 1 hour), and/or 1-month post-use VR (+/- 7 days).

Secondary Outcomes (10)

• Self-reported Mood Disturbance as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety Short Form

  Baseline, 1-week post-use virtual reality (VR (+/- 3 days), and/or 1-month post-use VR (+/- 7 days)

• Self-reported Mood Disturbance as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression Short-Form

  Baseline, 1-week post-use virtual reality (VR (+/- 3 days), and/or 1-month post-use VR (+/- 7 days)

• Proportion of Participants With High (Moderate/Severe) Distress (Based on Distress Thermometer (DT) Cut-off Score of Greater Than or Equal to 5) Compared to Those With Low Distress (Based on DT Scores of 0-.4) on the 0-10 Numeric Scale

  Baseline, immediate post-use VR (within 1 hour), 1-week post-use VR (+/- 3 days), and/or 1-month post-use VR (+/- 7 days)

• Effect Sizes of Acute and Subacute Distress That Indicate Moderate-Severe Distress as Measured by the National Comprehensive Cancer Network (NCCN) Distress Thermometer

  Baseline, immediate post-use VR (within 1 hour), 1-week post-use VR (+/- 3 days), and/or 1-month post-use VR (+/- 7 days)

• Proportion of Participants Reporting Any Moderate to Severe (≥5) Symptoms on the 0-10 Numeric Rating Scale as Measured by the MD Anderson Symptom Inventory-Brain Tumor [MDASI-BT])

  Baseline, 1-week post-use virtual reality (VR (+/- 3 days), and 1-month post-use VR (+/- 7 days)

Other Outcomes (2)

• Number of Participants Analyzed for Symptomatic Adverse Events Measured by the Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

  Baseline, immediate post-use Virtual Reality (VR) (within 1 hour) and 1-month post-use VR

• Number of Participants With Symptomatic Adverse Events Measured by the Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Reported by Term

  Baseline, immediate post-virtual reality (VR (within 1 hour), and/or post-VR 1 month later (+/- 7 days)

Study Arms (1)

Experimental Virtual Reality (VR) Intervention, Survey/Questionnaire Completion & Sample Submission

EXPERIMENTAL

Experimental Virtual Reality (VR) Intervention, Survey or Questionnaire Completion and Sample Submission. This is a single arm study where all participants were given the Applied VR device to potentially reduce distress and anxiety.

Device: Pico G2 4K Headset with Applied VR software; Other: Patient Reported Questionnaires; Biological: Saliva sample collection (hormones)

Interventions

Pico G2 4K Headset with Applied VR software DEVICE

Headset used for 4 weeks while on study.

Also known as: Pico G2 4K Headset with Applied virtual reality (VR) software

Experimental Virtual Reality (VR) Intervention, Survey/Questionnaire Completion & Sample Submission

Patient Reported Questionnaires OTHER

Patient reported questionnaires completed at baseline, post virtual reality (VR) within 1 hour, post VR 1 week later (+/- 3 days), and/or post VR 1 month later (+/- 7 days).

Experimental Virtual Reality (VR) Intervention, Survey/Questionnaire Completion & Sample Submission

Saliva sample collection (hormones) BIOLOGICAL

Optional (per principal investigator and participant discretion). Saliva taken at baseline and post virtual reality (VR) (within 1 hour).

Experimental Virtual Reality (VR) Intervention, Survey/Questionnaire Completion & Sample Submission

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary brain tumor (PBT) patients enrolled on the Natural History Study (NHS) trial (16C0151) in the Neuro-Oncology Branch (NOB) who have an upcoming scan and clinical appointment
• Participants can be newly diagnosed, receiving active treatment, or on surveillance
• Concurrent enrollment in other NOB trials is permissible
• Adults (greater than or equal to 18 years of age) who are English-speaking
• Participants must be able to reliably self-report symptoms, based on clinician assessment
• Participants report greater than or equal to 1 on distress item from MD Anderson Symptom Inventory (MDASI) Brain Tumor (MDASI-BT) prior to clinic appointment
• Active corticosteroid therapy is permissible
• Ability of subject to understand and the willingness to sign a written informed consent document

You may not qualify if:

• Participants who do not have a tissue diagnosis (no past surgery or biopsy to confirm diagnosis)
• Cranial surgery less than or equal to 2 weeks prior to initiation of study intervention
• Scalp wound healing issues that might interfere with comfortable virtual reality (VR) headset use
• Those who have epilepsy or have had a seizure in the last 6 weeks
• Participants with a current diagnosis of generalized anxiety disorder (GAD), post-traumatic stress disorder (PTSD), claustrophobia, or panic disorder
• Participants who have a hypersensitivity to motion or severe nausea, which could make the VR experience uncomfortable
• Those with visual deficits that might interfere with the VR experience, including hemianopsia, diplopia, and agnosia based on their most recent clinical assessment

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (7)

• Lin L, Chiang HH, Acquaye AA, Vera-Bolanos E, Gilbert MR, Armstrong TS. Uncertainty, mood states, and symptom distress in patients with primary brain tumors: analysis of a conceptual model using structural equation modeling. Cancer. 2013 Aug 1;119(15):2796-806. doi: 10.1002/cncr.28121. Epub 2013 May 9.

  PMID: 23661311 BACKGROUND

• Maples-Keller JL, Bunnell BE, Kim SJ, Rothbaum BO. The Use of Virtual Reality Technology in the Treatment of Anxiety and Other Psychiatric Disorders. Harv Rev Psychiatry. 2017 May/Jun;25(3):103-113. doi: 10.1097/HRP.0000000000000138.

  PMID: 28475502 BACKGROUND

• Niki K, Okamoto Y, Maeda I, Mori I, Ishii R, Matsuda Y, Takagi T, Uejima E. A Novel Palliative Care Approach Using Virtual Reality for Improving Various Symptoms of Terminal Cancer Patients: A Preliminary Prospective, Multicenter Study. J Palliat Med. 2019 Jun;22(6):702-707. doi: 10.1089/jpm.2018.0527. Epub 2019 Jan 24.

  PMID: 30676847 BACKGROUND

• King AL, Acquaye-Mallory AA, Vera E, Mendoza T, Reyes J, Stockdill ML, Gilbert MR, Armstrong TS. 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. BMC Cancer. 2023 Mar 21;23(1):262. doi: 10.1186/s12885-023-10671-2.

  PMID: 36944930 DERIVED

• King AL, Roche KN, Leeper HE, Vera E, Mendoza T, Mentges K, Acquaye-Mallory AA, Adegbesan KA, Boris L, Burton E, Choi A, Grajkowska E, Kunst T, Levine J, Lollo N, Miller H, Panzer M, Penas-Prado M, Pillai V, Polskin L, Reyes J, Sahebjam S, Stockdill ML, Theeler BJ, Wu J, Gilbert MR, Armstrong TS. Feasibility of a virtual reality intervention targeting distress and anxiety symptoms in patients with primary brain tumors: Interim analysis of a phase 2 clinical trial. J Neurooncol. 2023 Mar;162(1):137-145. doi: 10.1007/s11060-023-04271-0. Epub 2023 Mar 8.

  PMID: 36884201 DERIVED

• King AL, Acquaye AA, Mendoza T, Reyes J, Stockdill M, Gilbert MR, Armstrong TS, Vera E. 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. Res Sq [Preprint]. 2023 Feb 16:rs.3.rs-2521990. doi: 10.21203/rs.3.rs-2521990/v1.

  PMID: 36865245 DERIVED

• King AL, Roche KN, Leeper HE, Vera E, Mendoza T, Mentges K, Acquaye AA, Adegbesan K, Boris L, Burton E, Choi A, Grajkowska E, Kunst T, Levine J, Lollo N, Miller H, Panzer M, Penas-Prado M, Pillai V, Polskin L, Reyes J, Sahebjam S, Stockdill M, Theeler BJ, Wu J, Gilbert MR, Armstrong TS. Feasibility of a virtual reality intervention targeting distress and anxiety symptoms in patients with primary brain tumors: Interim analysis of a phase 2 clinical trial. Res Sq [Preprint]. 2023 Jan 31:rs.3.rs-2522094. doi: 10.21203/rs.3.rs-2522094/v1.

  PMID: 36789426 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Anxiety Disorders; Brain Neoplasms

Interventions

Hormones

Condition Hierarchy (Ancestors)

Mental Disorders; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Dr. Tito Mendoza
• Organization: National Cancer Institute

tito.mendoza@nih.gov

240-760-7084

Study Officials

• Tito R Mendoza, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 9, 2020
• Study Start: March 18, 2021
• Primary Completion: February 4, 2025
• Study Completion: February 4, 2025
• Last Updated: March 11, 2026
• Results First Posted: March 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.
• Access Criteria: All studies due to Biomedical Translational Research Information System (BTRIS): Clinical data available during the study and indefinitely.

Locations

US (1)