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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
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:Select...
I have been diagnosed with GAD, PTSD, claustrophobia, or panic disorder.
Select...
I have not had brain surgery in the last 2 weeks.
Select...
My diagnosis was made without a tissue sample.
Select...
I have epilepsy or had a seizure in the last 6 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study
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 moreTrial 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
13,842 Previous Clinical Trials
41,002,880 Total Patients Enrolled
18 Trials studying Anxiety
12,542 Patients Enrolled for Anxiety
Amanda L King, Ph.D.Principal InvestigatorNational Cancer Institute (NCI)
1 Previous Clinical Trials
160 Total Patients Enrolled
Terri S Armstrong, C.R.N.P.Principal InvestigatorNational Cancer Institute (NCI)
5 Previous Clinical Trials
1,683 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with GAD, PTSD, claustrophobia, or panic disorder.I have not had brain surgery in the last 2 weeks.I do not have vision problems that would affect using VR, like double vision or partial sight loss.I have scalp problems that could make wearing a VR headset uncomfortable.I am newly diagnosed, currently receiving treatment, or being monitored for my condition.You get really dizzy or sick when you move around a lot, which might make using virtual reality uncomfortable for you.My diagnosis was made without a tissue sample.I am part of the NHS trial for brain tumors and have an upcoming scan.I am 18 years or older and speak English.I am currently taking corticosteroid medication.You report feeling very distressed before coming to the clinic.I have epilepsy or had a seizure in the last 6 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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