This is a single arm study. All participants will participate in the study intervention, which involves experiencing a virtual reality program.

Study participants will be provided a HTC or Pico VR head-mounted device (HTC Flow, HTC Focus or Pico Neo Pro) which will be fitted for comfort. Patients will remain seated for the entirety of the VR program. The program generally takes about ten minutes to complete but may last up to 11 minutes. The program displays a relaxing environmental setting with narration based in mindfulness meditation principles. Subjects will be prompted to practice breathing exercises designed to relax and reduce anxiety.

Virtual Reality Program

Ching Lai

Michell Kim

Michael LaRiviere, MD

The purpose of this study is to assess the feasibility of a pre-simulation virtual reality (VR) platform designed to promote relaxation for cancer patients planned for radiation therapy (RT).

The purpose of this prospective feasibility study is to assess the implementation of a VR-based intervention in patients who are pending initiation of RT. The investigators hypothesize that this intervention will be safe and feasible. If 75% of enrolled patients complete the VR intervention (defined as at least 8 min before permanent discontinuation), then feasibility will be met. Ten minutes' length is likely to be tolerated by most patients and likely to provide benefit. The maximum length of the VR video is 11 minutes. Patients will still be evaluable after 8 minutes of the video as this provides ample time to practice mindfulness based breathing exercises.

As this is a feasibility study, investigators and participants will not be blinded to study procedures. Potential study participants will be adult patients who are undergoing simulation for radiation treatment planning at the Perelman Center for Advanced Medicine at Penn Medicine. This is a single site study. No interim analyses or sub-studies are planned. Based on the expected accrual of 25 patients, futility and early termination will be triggered if 6 participants fail to meet the conditions described above.

Virtual Reality to Promote Relaxation Prior to Simulation

Virtual Reality to Promote Mindfulness and Relaxation Prior to Radiation Simulation: A Prospective Pilot Feasibility Study

Feasibility based on the ability of at least 75% patient VR completion rate. Based on the expected accrual of 25 patients, futility and early termination will be triggered if six participants fail to meet the conditions described above.

To collect patient feedback on the usability of and overall satisfaction with the VR program prior to simulation. Post-intervention survey designed to collect qualitative and quantitative patient feedback.

To evaluate patient-reported situational anxiety levels prior to and after use of the VR headset.

Measure baseline score on Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item scale with seven items for each anxiety and depression. Subscale scores greater than 8 denotes anxiety or depression.

To evaluate patient-reported situational anxiety levels prior to and after use of the VR headset.

Measure change in the State-Trait Anxiety Inventory (STAI-6) score at baseline and after VR intervention. The STAI-6 is adapted from the original 20-item STAI. The original STAI scores range from 20-80. A score of 40 or higher is correlated with high anxiety. The STAI-6 consists of six questions rated on a 1-4 Likert scale creating a score range from 6 to 24. In order to generate scores compatible with the original STAI, STAI-6 scores will be multiplied by 20 and divided by 6 to give a range between 20-80.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Virtual Reality to Promote Relaxation Prior to Simulation	NCT06318338	Cancer	Virtual Reality...	18 Years -	Abramson Cancer Center at Penn Medicine
Virtual Reality to Promote Relaxation Prior to Simulation	NCT06318338	Cancer	Virtual Reality...	18 Years -	Abramson Cancer Center at Penn Medicine

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