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

Background:

- Psychological distress is a common concern for patient across the cancer trajectory, which has been associated with worse clinical outcomes in terms of quality of life, adherence to treatment regimens, satisfaction with care, and poorer survival in past research.

- Virtual reality (VR) has the potential to alleviate some of the negative aspects of illness by allowing individuals to escape from their lives and experience more positive thoughts and emotions, which can be accomplished using cardiac coherence breathing techniques and distraction (both of which can improve psychological symptoms).

- Past VR research has shown promising improvements in anxiety, pain, distress and distraction through use of immersive VR interventions, though there is scant evidence in PBT populations, particularly in the time period surrounding their neuroimaging and clinical appointments when distress and anxiety can be highest.

- The purpose of this phase II clinical trial is to determine the feasibility of implementing an immersive VR relaxation intervention in a PBT population and to assess the efficacy of the intervention to improve psychological distress and anxiety at the time of clinical evaluation. VR is an innovative delivery approach to teach our patients validated breathing and mindfulness techniques that can improve their psychological symptoms and their ability to self-manage these symptoms.

Objective:

-To describe the feasibility of implementing a VR intervention in a PBT population, including eligibility, accrual, compliance, adverse device effects, study completion, and participant satisfaction with the intervention

Eligibility:

- PBT patients enrolled on the Natural History Study (NHS) trial in the Neuro-Oncology Branch (NOB) (all tumor types and grades eligible)

- Patients can be newly diagnosed, receiving active treatment, or on surveillance

- Adults (greater than or equal to 18 years of age) who are English-speaking and able to self-report symptoms

- Active corticosteroid therapy is permissible

- Exclude patients without tissue diagnosis, recent cranial surgery (less than or equal to 2 weeks), scalp wound healing issues, epilepsy, or seizures within the last 6 weeks

- Exclude patients who have a hypersensitivity to motion, severe nausea, or visual field deficits that might interfere with VR experience

Design:

- This is a phase II feasibility clinical trial with a single arm experimental design.

- Study will include collection of self-reported patient outcome measures (PROs) for distress, anxiety, mood disturbance, and symptom burden/interference, as well as salivary stress biomarkers, all of which are collected at baseline and immediately after a brief VR relaxation intervention to determine acute effects on distress, anxiety, and biological stress measures. Repeat post-intervention assessments of all outcome measures will be done approximately 1 week and 1 month following the initial intervention to determine sub-acute effects on all PROs and biological measures once patients have returned home from their appointment. A semi-structured qualitative interview will also be conducted 1 week after the initial intervention to assess participant satisfaction with the intervention.

- Descriptive statistics, T-tests, Wilcoxon rank sum tests, and multiple logistic regression models will be used to evaluate the feasibility of the VR intervention. Linear mixed models and effect size calculations will be used to evaluate the acute and sub-acute effects of the VR intervention on self-reported PROs. Pearson or Spearman correlations will be used to evaluate the relationship between the biological stress measures and self-reported PROs.

- A total of 120 PBT patients will participate in this study.