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 : Not yet recruiting
First Posted : March 9, 2020
Last Update Posted : April 7, 2020
Distress, anxiety, and other psychological disorders may be more common in people with primary brain tumors (PBTs). PBTs can affect their symptoms and quality of life. PBTs can also affect their tolerance of cancer treatments. Researchers want to learn if virtual reality (VR) technology can help. VR uses computer technology to make fake experiences and environments that look real. It lets people 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 PBT.
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
Participants will give saliva samples at 4 time points. They will fill out 4 questionnaires at 4 times points. These forms are not part of the NHS. The 4 time points are:
before the VR intervention in clinic
after the VR intervention in clinic
1 week later at home
1 month later at home
Participants will get a VR headset. It looks like a thick pair of goggles that goes over the eyes. Participants will view computer-generated environments on this headset.
Participants will have a phone interview 1 week after the VR viewing. It will last 10 to 15 minutes.
This study will also use the forms and questionnaires that the participants fill out as part of the NHS.
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 (Clinical Trial)|
|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|
|Estimated Study Start Date :||April 10, 2020|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||January 31, 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: Sonja K Crandon, R.N.||(240) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center|
|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)|