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VR Therapy for Anxiety in Brain Tumor Patients

Phase 2
Recruiting
Led By Terri S Armstrong, C.R.N.P.
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
Participants can be newly diagnosed, receiving active treatment, or on surveillance
Active corticosteroid therapy is permissible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study
Awards & highlights

Study 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.Check my eligibility
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.See study design
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

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am newly diagnosed, currently receiving treatment, or being monitored for my condition.
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I am currently taking corticosteroid medication.
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I am part of the NHS trial for brain tumors and have an upcoming scan.
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I am 18 years or older and speak English.

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

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

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
13,627 Previous Clinical Trials
40,927,227 Total Patients Enrolled
18 Trials studying Anxiety
12,542 Patients Enrolled for Anxiety
Terri S Armstrong, C.R.N.P.Principal InvestigatorNational Cancer Institute (NCI)
5 Previous Clinical Trials
10,511 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many enrollees are in this clinical trial?

"Yes, the trial is still open and recruiting patients. It was originally posted on March 18th, 2021 and updated as recently as October 15th, 2022. They are looking for a total of 120 participants across 1 site."

Answered by AI

Are patients currently being accepted into this program?

"That is correct, the online information does state that the study is recruiting. The trial was initially posted 18th March 2021 and updated on 15th October 2022. They are looking for a total of 120 individuals from 1 site."

Answered by AI

Could you please tell me what risks are associated with the Pico G2 4K Headset with Applied VR software?

"Given that this is a phase 2 trial, and thus there is only some data supporting safety but not efficacy, our team at Power estimates the Safety of Pico G2 4K Headset with Applied VR software to be a 2."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Maryland
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
National Institutes of Health Clinical Center
Recent research and studies
~22 spots leftby Dec 2024