Background
- Psychological distress is a common concern for patients 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 mindfulness,
breathing techniques and distraction (all 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 primary brain tumors (PBTs) population, particularly in the time period
surrounding their neuroimaging and clinical appointments when distress and anxiety
can be highest.
- Recent evidence has demonstrated that the coronavirus disease 2019 (COVID-19)
pandemic and associated mitigation procedures introduce additional stress for cancer
patients, with higher levels of anxiety, depression, loneliness, and financial
toxicity being reported during this time.
- 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.
Objectives
-To describe the feasibility of implementing a VR intervention in a PBT population,
including eligibility, accrual, compliance, device-related adverse 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
- Participants have reported greater than or equal to 1 on distress item from MD
Anderson Symptom Inventory (MDASI) Brain Tumor (MDASI-BT) prior to past clinic
appointment
- Exclude patients without tissue diagnosis, recent cranial surgery (less than or
equal to 2 weeks), scalp wound healing issues, or seizures within the last 6 weeks
- Exclude patients who have a hypersensitivity to motion, severe nausea, or
significant visual field deficits that might interfere with VR experience (including
hemianopsia, diplopia, and agnosia)
- Exclude patients with a current diagnosis of generalized anxiety disorder (GAD),
post-traumatic stress disorder (PTSD), claustrophobia, or panic disorder
Design
- This is a phase II feasibility clinical trial with a single arm experimental design.
The VR intervention and all patient-reported outcome measures (PROs) will be done
remotely using telehealth.
- Study will include collection of self-reported PROs for distress, anxiety, mood
disturbance, symptom burden/interference, quality of life, cognitive function,
loneliness, and financial toxicity, as well as optional salivary stress biomarkers.
These measures will be 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 will be done
approximately 1 week and 1 month following the initial intervention to determine
sub-acute effects on distress and anxiety, as well as impact on other symptoms. A
semi-structured qualitative interview will also be conducted 1 month after the
initial intervention to assess participant satisfaction with the intervention and
how the pandemic has affected their psychological symptoms.
- 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 PRO's. Pearson or
Spearman correlations will be used to evaluate the relationship between the
biological stress measures and self-reported PRO's.
- A total of 120 PBT patients will participate in this study.
