Status:
COMPLETED
Immersive Virtual Reality (VR) at the Time of Clinical Evaluation to Improve Psychological Distress and Anxiety in Primary Brain Tumor (PBT) Patients
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Anxiety
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Detailed Description
Background * Psychological distress is a common concern for patient across the cancer trajectory, which has been associated with worse clinical outcomes in terms of quality of life, adherence to trea...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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 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
Exclusion
Key Trial Info
Start Date :
March 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 4 2025
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04301089
Start Date
March 18 2021
End Date
February 4 2025
Last Update
February 21 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892