Discussion
primary brain tumors, anxiety, cancer, cognitive dysfunction, brain tumors
PRIMARY BRAIN TUMORS, CANCER, BRAIN TUMOR, RECRUITMENT, BRAIN TUMORS
Use of VR has the potential to ameliorate some of the negative aspects of cancer that patients endure and allows them to escape to more pleasant environments and experience more positive thoughts and emotions to aid with coping [Screening and enrollment for this trial proved to be feasible in this population, despite fairly conservative eligibility criteria to ensure safety of enrolled participants. Most patients who were pre-screened and approached for the study were interested in participating. This likely relates to a high prevalence of distress, which was likely heightened during the COVID-19 pandemic [Overall, the intervention and study procedures were found to be both feasible and acceptable based on high completion rates for all assessments, zero attrition from the study, and favorable responses to the WIWI questions during the qualitative phone interview. Through weekly check-ins with the patients and study team, we were able to attain 100% data completion for all PROs electronic questionnaires with only 4 deviations for assessments received outside of the pre-determined time windows. Some of the reasons that patients with brain tumors tend to be excluded from clinical trials include a perceived lack of interest in participating in trials or clinician concern for severe cognitive dysfunction in the patients that might prohibit them from following study procedures [A unique aspect of this trial is that the VR intervention was delivered remotely with patients using the device in their own home. While none of us were used to communicating with patients exclusively via telehealth platforms prior to the COVID-19 pandemic, there were some distinct advantages to this remote approach that may have positively impacted feasibility and acceptability of the VR intervention. Once we all had adapted to using the various virtual platforms, communication with patients was relatively easy there was more flexibility in arranging times for meetings and patients did not have to travel to the NIH to participate. Furthermore, patients were much more likely to be relaxed when using the VR device while in their home environments [A main limitation for this trial is its single-center, non-randomized design. As this is the first VR-based interventional trial in the brain tumor population, it was important to demonstrate feasibility and preliminary efficacy prior to launching a larger randomized study. Additionally, conducting this study during a global pandemic presented challenges for recruitment and also may have biased the types of patients enrolled. Lastly, these findings are from an interim analysis with a relatively small sample and require confirmation in a larger study where feasibility and preliminary efficacy of the intervention can be established. These analyses are planned and will be reported once all patients have been recruited.In conclusion, findings from this phase 2 trial interim analysis suggest that use of VR to target distress and anxiety symptoms in patients with primary brain tumors at the time of clinical evaluation is both feasible and acceptable and can be administered remotely. Continuation of this trial to collect data from the remaining sample is warranted and will allow further assessment of these feasibility metrics, as well as establishing preliminary efficacy for improving these psychological symptoms in the neuro-oncology population.