Virtual Reality to Promote Relaxation Prior to Simulation

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06318338
• Other study ID #: UPCC 14523
• Secondary ID: 854756
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2024
• Est. completion date: March 2025

Study information

• Verified date: May 2024
• Source: Abramson Cancer Center at Penn Medicine
• Contact: Ching Lai
• Phone: 267-250-9244
• Email: Ching.Lai[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able to understand, read or speak English sufficient for signing of informed consent and completion of study assessments

• Patients scheduled for simulation for radiation treatment planning at Perelman Center for Advanced Medicine (PCAM)

• Adults, at least 18 years of age

• Performance Status (ECOG) 0-2

Exclusion Criteria:

• Prior radiotherapy

• Has a history of motion sickness, car sickness, vertigo, epilepsy, seizures, migraines, or light sensitivity

• Current nausea, vomiting, dizziness, lightheadedness, monocular vision or hearing loss

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Perelman Center for Advanced Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of a pre-simulation VR platform prior to radiation	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.	12 months
Secondary	Patient feedback on pre-simulation VR program	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.	12 months
Secondary	Patient situational anxiety prior to and after use of VR program (HADS)	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.	12 months
Secondary	Patient situational anxiety prior to and after use of VR program (STAI-6)	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.	12 months