Virtual Reality to Promote Relaxation Prior to Simulation

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Other: Virtual Reality Program

• Registration Number: NCT06318338
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Study Timeline

• Study First Submitted: 2024-03-13
• Study First Submitted QC: 2024-03-13
• Study First Posted: 2024-03-19
• Study Start: 2024-04-08
• Status Verified: 2025-02
• Primary Completion: 2025-02-12
• Study Completion: 2025-02-12
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Able to understand, read or speak English sufficient for signing of informed consent and completion of study assessments
2. Patients scheduled for simulation for radiation treatment planning at Perelman Center for Advanced Medicine (PCAM)
3. Adults, at least 18 years of age
4. Performance Status (ECOG) 0-2

Exclusion Criteria

1. Prior radiotherapy
2. History of motion sickness, car sickness, vertigo, migraines, or light sensitivity within the last 6 months
3. History of epilepsy and seizures
4. Current nausea, vomiting, dizziness, lightheadedness, monocular vision or hearing loss that is not treated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Virtual Reality Program	Virtual Reality Program	This is a single arm study. All participants will participate in the study intervention, which involves experiencing a virtual reality program.

Primary Outcome Measures

Name	Time	Method
Feasibility of a pre-simulation VR platform prior to radiation	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Patient situational anxiety prior to and after use of VR program (STAI-6)	12 months	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.
Patient feedback on pre-simulation VR program	12 months	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.
Patient situational anxiety prior to and after use of VR program (HADS)	12 months	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.

Trial Locations

Locations (1)

Perelman Center for Advanced Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States