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VR Therapy for Anxiety in Brain Tumor Patients

Phase 2
Recruiting
Led By Amanda L King, Ph.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Participants with a current diagnosis of generalized anxiety disorder (GAD), post-traumatic stress disorder (PTSD), claustrophobia, or panic disorder
Cranial surgery less than or equal to 2 weeks prior to initiation of study intervention
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying whether it is feasible to use a VR relaxation intervention to help people with primary brain tumors who have recently reported psychological distress.

Who is the study for?
This trial is for adults over 18 with primary brain tumors who are part of the Natural History Study and have reported psychological distress. They must be English-speaking, able to self-report symptoms, and can be on active treatment or surveillance. People with recent cranial surgery, healing scalp wounds, seizures, certain anxiety disorders, motion hypersensitivity or visual deficits that affect VR use cannot join.
What is being tested?
The study tests if using a Pico G2 4K Headset with Applied VR software at home can reduce stress and improve mood in brain tumor patients. Participants will use the headset remotely during telehealth sessions and complete questionnaires before and after the intervention as well as one week and four weeks later.
What are the potential side effects?
Potential side effects may include discomfort from wearing the VR headset if there's a scalp wound healing issue; nausea or motion sensitivity due to VR experience; worsening of pre-existing conditions like epilepsy could occur but those individuals are excluded.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with GAD, PTSD, claustrophobia, or panic disorder.
Select...
I have not had brain surgery in the last 2 weeks.
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My diagnosis was made without a tissue sample.
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I have epilepsy or had a seizure in the last 6 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants who complete the sessions and questionnaires
Secondary study objectives
Adrenal Cortex Hormones
Measurement of Distress
Measurement of distress and anxiety
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental interventionExperimental Treatment1 Intervention
Experimental VR Intervention, Survey or Questionnaire Completion and Sample Submission

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,956 Previous Clinical Trials
41,112,064 Total Patients Enrolled
20 Trials studying Anxiety
12,791 Patients Enrolled for Anxiety
Amanda L King, Ph.D.Principal InvestigatorNational Cancer Institute (NCI)
1 Previous Clinical Trials
2 Total Patients Enrolled
Terri S Armstrong, C.R.N.P.Principal InvestigatorNational Cancer Institute (NCI)
5 Previous Clinical Trials
1,525 Total Patients Enrolled

Media Library

Immersive Virtual Reality Clinical Trial Eligibility Overview. Trial Name: NCT04301089 — Phase 2
Anxiety Research Study Groups: Experimental intervention
Anxiety Clinical Trial 2023: Immersive Virtual Reality Highlights & Side Effects. Trial Name: NCT04301089 — Phase 2
Immersive Virtual Reality 2023 Treatment Timeline for Medical Study. Trial Name: NCT04301089 — Phase 2
~12 spots leftby Jun 2025
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