Immersive Virtual Reality (VR) at the Time of Clinical Evaluation to Improve Psychological Distress and Anxiety in Primary Brain Tumor (PBT) Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04301089|
Recruitment Status : Recruiting
First Posted : March 9, 2020
Last Update Posted : April 26, 2021
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.
To learn if it is feasible to use a VR relaxation intervention in people with PBTs.
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
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|
|Study Type :||Interventional|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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
- 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])
- 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)
- 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
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
|Contact: NCI NOB Referral Group||(866) email@example.com|
|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|
|Principal Investigator:||Terri S Armstrong, C.R.N.P.||National Cancer Institute (NCI)|