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: Unknown

28 Participants Needed

Trial Summary

What is the purpose of this trial?

Background: Distress, anxiety, and other psychological disorders may be more common in people with primary brain tumors (PBTs). PBTs can affect their symptoms, quality of life, and their tolerance of cancer treatments. Researchers want to learn if virtual reality (VR) technology can help reduce stress and improve mood. VR uses computer technology to make fake experiences and environments that look real. This allows people to escape from their lives and experience more positive thoughts and emotions. Objective: To learn if it is feasible to use a VR relaxation intervention in people with PBTs. Eligibility: 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 Design: The VR intervention and all patient-reported outcome measures (PROs) will be done remotely using telehealth. Participants will be mailed a VR headset. This headset looks like a thick pair of goggles that is worn over the eyes. Participants will view computer-generated environments on this VR headset. Participants will fill out symptoms questionnaires at 4 different times points during participation in this study, including questionnaires for the NHS as well as 4 questionnaires unique to this study. There are also optional saliva samples collected at these timepoints. The 4 timepoints are: * Before the VR intervention * After the VR intervention * 1 week later * 4 weeks later Participants will also have a phone interview 1 week after the initial VR interevention, which will last 10 to 15 minutes. Participation lasts 4 to 6 weeks.

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 data supports the idea that VR Therapy for Anxiety in Brain Tumor Patients (also known as: Immersive Virtual Reality) is an effective treatment?

The available research shows that VR Therapy is promising for reducing anxiety in brain tumor patients. In a study, 90% of participants reported frequent use of VR and high satisfaction with the treatment. Additionally, the study found that the VR intervention was feasible and well-accepted by patients, with only mild side effects like headaches and dizziness. This suggests that VR Therapy could be an effective way to manage anxiety in these patients. ^{1 2 3 4 5}

What safety data exists for VR therapy in brain tumor patients?

The interim analysis of a phase 2 clinical trial on VR therapy for primary brain tumor patients reported that the intervention is feasible and acceptable. Out of 20 enrolled patients, 90% reported frequent use and high satisfaction with the VR therapy. Only 7 mild adverse effects were recorded, including headache, dizziness, nausea, and neck pain. This suggests that VR therapy is generally safe for this patient group. ^{1 2 3 4 6}

Is Immersive Virtual Reality a promising treatment for anxiety in brain tumor patients?

Yes, Immersive Virtual Reality is a promising treatment for anxiety in brain tumor patients. It has shown potential in reducing distress and anxiety, especially during stressful times like medical evaluations. Patients have reported high satisfaction with the treatment, and it is considered feasible and acceptable. ^{1 2 3 7 8}

Research Team

Amanda L King, Ph.D.

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

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.

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2023]

2. England 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. [2023]

3. United States 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. [2023]

4. United States 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. [2023]

5. United States 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. [2023]

6. Scotland 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. [2022]

7. Scotland pubmed.ncbi.nlm.nih.gov

Effectiveness of Virtual Reality Vs Guided Imagery on mood changes in cancer patients receiving chemotherapy treatment: A crossover trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Immersive Virtual Reality in People with Cancer Undergoing Antiblastic Therapy: A Randomized Controlled Trial. [2023]