Spots Global Cancer Trial Database for Virtual Reality to Promote Relaxation Prior to Simulation

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Trial Identification

Brief Title: Virtual Reality to Promote Relaxation Prior to Simulation

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

Study ID: NCT06318338

Conditions

Cancer

Interventions

Virtual Reality Program

Study Description

Brief Summary: 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).

Detailed Description: 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.