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

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ClinicalTrials.gov Identifier: NCT04301089
Recruitment Status : Recruiting
First Posted : March 9, 2020
Last Update Posted : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

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 symptoms 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 collected at these timepoints. The 4 timepoints are:

  • Before the VR intervention
  • After the VR intervention
  • 1 week later
  • 4 weeks later

Participants will also have a phone interview 1 week after the initial VR interevention, which will last 10 to 15 minutes.

Participation lasts 4 to 6 weeks.


Condition or disease Intervention/treatment Phase
Anxiety Device: Pico G2 4K Headset with Applied VR software Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 18, 2021
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental intervention
Experimental VR Intervention, Survey or Questionnaire Completion and Sample Submission
Device: Pico G2 4K Headset with Applied VR software
headset worn at time points defined in study




Primary Outcome Measures :
  1. Number of participants who complete the sessions and questionnaires [ Time Frame: End of Study ]
    To describe the feasibility of implementing a VR intervention in a PBT population, including eligibility, accrual, compliance, adverse events, study completion, and participant satisfaction with the intervention


Secondary Outcome Measures :
  1. Measurement of mood disturbance [ Time Frame: End of Study ]
    To assess the effects of a VR intervention on self-reported mood disturbance (as measured by PROMIS -Anxiety & PROMIS -Depression Short Forms) and symptom burden and interference (as measured by the MD Anderson Symptom Inventory Brain Tumor [MDASI-BT])

  2. Measurement of distress and anxiety [ Time Frame: End of Study ]
    To determine if the effects VR has on distress and anxiety are more pronounced in those with high distress (based on DT cut-off score of greater than or equal to 5) compared those with to low distress (based on DT scores of 0 4)

  3. Measurement of Distress [ Time Frame: End of Study ]
    To assess the effects of a VR intervention on self-reported acute and subacute distress (as measured by the NCCN Distress Thermometer [DT]) and anxiety (as measured by the State Anxiety Inventory [STAI-6]) in PBT patients

  4. Measurement and comparison of distress and anxiety on those on systemic corticosteroids [ Time Frame: End of Study ]
    To determine if the effects VR has on distress and anxiety are more pronounced in those individuals not on systemic corticosteroids (CS) compared to those who are



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • PBT patients enrolled on the Natural History Study (NHS) trial (16C0151) in the Neuro-Oncology Branch (NOB) who have an upcoming scan & 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 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

EXCLUSION CRITERIA:

  • 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04301089


Contacts
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Contact: NCI NOB Referral Group (866) 251-9686 ncinobreferrals@mail.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    888-624-1937      
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Terri S Armstrong, C.R.N.P. National Cancer Institute (NCI)
Additional Information:
Publications:
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT04301089    
Other Study ID Numbers: 200065
20-C-0065
First Posted: March 9, 2020    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: July 28, 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Therapeutic VR Platform
Scanxiety
Brain Cancer
Brain Tumors
Additional relevant MeSH terms:
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Brain Neoplasms
Anxiety Disorders
Mental Disorders
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases