VR Therapy for Anxiety in Brain Tumor Patients

Overseen By Amanda L King, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Disqualifiers: Epilepsy, Seizures, Anxiety disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether virtual reality (VR) can reduce stress and improve mood in individuals with primary brain tumors. VR generates computer-created environments that feel real, enabling users to escape and experience positive emotions. Participants will use a VR headset to engage in relaxation sessions from home. Individuals with a brain tumor experiencing psychological distress may qualify for this trial. Participants will provide feedback through surveys and a brief phone interview. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, active corticosteroid therapy is allowed, so it seems likely that you can continue your current medications.

What prior data suggests that this VR therapy is safe for brain tumor patients?

Research has shown that immersive virtual reality (VR) is generally safe for people with brain tumors. Studies have found that VR can reduce anxiety and stress in cancer patients. In these studies, patients reported feeling less anxious and more relaxed. No major safety issues have been reported with VR use for these purposes.

VR allows people to experience different settings through a headset, helping to distract them from stress. This method has been well-received, with most people experiencing no negative side effects. While this trial focuses on brain tumor patients, similar VR methods have been safely used with other cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about immersive virtual reality (VR) therapy for anxiety in brain tumor patients because it offers a novel, non-invasive approach to managing anxiety symptoms. Unlike standard treatments such as medication or traditional therapy, VR provides an immersive experience that can help patients escape from their stressors and practice coping mechanisms in a controlled, virtual environment. This method allows for real-time feedback and customization to the individual's needs, potentially leading to quicker and more personalized relief from anxiety symptoms. By leveraging technology, VR therapy could revolutionize how anxiety is treated in this specific patient population, making it a promising alternative to conventional methods.

What evidence suggests that this VR therapy is effective for anxiety in brain tumor patients?

Research has shown that virtual reality (VR) can lower anxiety and stress in patients with primary brain tumors. One study found that VR significantly reduced anxiety and tiredness in cancer patients compared to regular care. Another review discovered that VR decreased distress, anxiety, and depression in people with solid tumors. In this trial, participants will experience an immersive VR intervention, providing an escape and promoting positive feelings and thoughts. These findings suggest that VR could be a useful tool for improving mood and reducing stress in brain tumor patients. ^{1 2 3 5 6}

Who Is on the Research Team?

Amanda L King, Ph.D.

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am newly diagnosed, currently receiving treatment, or being monitored for my condition.

Concurrent enrollment in other NOB trials is permissible

I am part of the NHS trial for brain tumors and have an upcoming scan.

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

VR Intervention

Participants receive a VR relaxation intervention to assess its feasibility and effects on psychological distress and anxiety

1 day

Remote session using telehealth

Follow-up

Participants are monitored for acute and sub-acute effects on distress and anxiety, with assessments at 1 week and 4 weeks post-intervention

4-6 weeks

Remote assessments at 1 week and 4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Immersive Virtual Reality

Trial Overview 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.

How Is the Trial Designed?

Group I: Experimental intervention Experimental Treatment 1 Intervention

Experimental VR Intervention, Survey or Questionnaire Completion and Sample Submission

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A phase 2 clinical trial involving 120 primary brain tumor patients aims to assess the feasibility of a remote virtual reality (VR) relaxation intervention to help reduce distress and anxiety, particularly during the stressful period before MRI scans.

The study will evaluate the preliminary efficacy of the VR intervention in improving psychological symptoms, with follow-up assessments conducted immediately after the intervention and at 1 and 4 weeks, potentially paving the way for larger trials in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary efficacy of a virtual reality intervention targeting distress and anxiety in primary brain tumor patients at the time of clinical evaluation: Study protocol for a phase 2 clinical trial. King, AL., Acquaye-Mallory, AA., Vera, E., et al.[2023]

This phase 2 clinical trial involves 120 primary brain tumor patients using a remote virtual reality (VR) relaxation intervention to help reduce distress and anxiety, particularly around MRI scans and clinical evaluations.

The study aims to establish the feasibility of this VR intervention and assess its preliminary effectiveness in improving psychological symptoms, potentially paving the way for larger trials and similar interventions for other cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary efficacy of a virtual reality intervention targeting distress and anxiety in primary brain tumor patients at the time of clinical evaluation: Study protocol for a phase 2 clinical trial. King, AL., Acquaye, AA., Mendoza, T., et al.[2023]

In a study of 74 cancer patients undergoing treatment, immersive Virtual Reality significantly reduced anxiety and fatigue compared to standard care, with a notable decrease in anxiety levels (Δpre-post = 6.24, p=.001).

The Virtual Reality intervention was effective in managing fatigue as well, while fatigue levels increased in the standard care group, indicating that Virtual Reality can be a beneficial complementary therapy during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Immersive Virtual Reality in People with Cancer Undergoing Antiblastic Therapy: A Randomized Controlled Trial. Burrai, F., Ortu, S., Marinucci, M., et al.[2023]

A virtual reality relaxation intervention was found to be feasible and acceptable for patients with primary brain tumors, with 50% enrollment from those approached and high satisfaction reported by 90% of participants.

The intervention had a low incidence of mild adverse effects (7 cases), indicating it is a safe option for managing distress and anxiety during neuroimaging procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a virtual reality intervention targeting distress and anxiety symptoms in patients with primary brain tumors: Interim analysis of a phase 2 clinical trial. King, AL., Roche, KN., Leeper, HE., et al.[2023]

In a randomized crossover trial involving 50 cancer patients undergoing chemotherapy, Virtual Reality (VR) significantly improved mood states compared to Guided Imagery (GI), indicating its potential as a beneficial intervention for emotional well-being during treatment.

The VR intervention also led to statistically significant improvements in biophysical parameters like blood pressure and heart rate, although it did not show effectiveness in reducing symptoms of nausea, pain, or feeling sick.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Virtual Reality Vs Guided Imagery on mood changes in cancer patients receiving chemotherapy treatment: A crossover trial. Ioannou, A., Paikousis, L., Papastavrou, E., et al.[2022]

A virtual reality relaxation intervention was found to be feasible and acceptable for patients with primary brain tumors, with 50% enrollment from those approached and high satisfaction reported by 90% of participants.

The intervention had a low incidence of mild adverse effects (only 7 reported), indicating it is a safe option for managing distress and anxiety during neuroimaging procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a virtual reality intervention targeting distress and anxiety symptoms in patients with primary brain tumors: Interim analysis of a phase 2 clinical trial. King, AL., Roche, KN., Leeper, HE., et al.[2023]

In a study involving 66 women with breast cancer undergoing chemotherapy, the use of virtual reality glasses significantly reduced anxiety levels, with lower scores observed throughout four treatment cycles compared to the control group.

The intervention also effectively decreased fatigue scores in the same group, suggesting that virtual reality can be a beneficial tool for improving the well-being of patients during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Using Virtual Reality Glasses on Anxiety and Fatigue in Women with Breast Cancer Receiving Adjuvant Chemotherapy: A Pretest-Posttest Randomized Controlled Study. Uslu, A., Arslan, S.[2023]

The study involving 19 pediatric cancer patients showed that immersive virtual reality significantly reduced anxiety and acute nausea during their first chemotherapy sessions, indicating its potential effectiveness as a supportive intervention.

The high consent and low withdrawal rates suggest that immersive virtual reality is not only feasible but also well-accepted by patients, parents, and healthcare providers in a clinical setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of immersive virtual reality for managing anxiety, nausea and vomiting among paediatric cancer patients receiving their first chemotherapy: An exploratory randomised controlled trial. Lee Wong, C., Li, CK., Choi, KC., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10030076/

Feasibility and preliminary efficacy of a virtual reality ... The primary aim of this study is to evaluate the feasibility of using a VR relaxation intervention to target distress and anxiety symptoms in a PBT ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04301089

NCT04301089 | Immersive Virtual Reality (VR) at the Time ... Immersive Virtual Reality (VR) at the Time of Clinical Evaluation to Improve Psychological Distress and Anxiety in Primary Brain Tumor (PBT) Patients.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9993385/

Feasibility of a virtual reality intervention targeting distress and ... A recent systematic review summarizing use of VR in solid tumor patients demonstrated promising improvements in distress, anxiety, and depression while also ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0749208123001146

Effectiveness of Immersive Virtual Reality in People with ... Findings show that virtual reality is effective to reduce anxiety and fatigue in people with cancer undergoing antiblastic therapy.

5. withpower.com withpower.com/trial/phase-3-anxiety-disorders-2-2021-c21dd

VR Therapy for Anxiety in Brain Tumor Patients In a study of 74 cancer patients undergoing treatment, immersive Virtual Reality significantly reduced anxiety and fatigue compared to standard care, with a ...

6. trialx.com trialx.com/clinical-trials/listings/274149/immersive-virtual-reality-vr-at-the-time-of-clinical-evaluation-to-improve-psychological-distress-and-anxiety-in-primary-brain-tumor-pbt-patients/

Immersive Virtual Reality (VR) at the Time of Clinical ... Immersive Virtual Reality (VR) at the Time of Clinical Evaluation to Improve Psychological Distress and Anxiety in Primary Brain Tumor (PBT) Patients.