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Virtual Reality to Promote Relaxation Prior to Simulation

Abramson Cancer Center at Penn Medicine logo

Abramson Cancer Center at Penn Medicine

Status

Completed

Conditions

Cancer

Treatments

Other: Virtual Reality Program

Study type

Interventional

Funder types

Other

Identifiers

NCT06318338
UPCC 14523
854756 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

Virtual Reality Program
Experimental group
Description:
This is a single arm study. All participants will participate in the study intervention, which involves experiencing a virtual reality program.
Treatment:
Other: Virtual Reality Program

Trial contacts and locations

1

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Central trial contact

Ching Lai; Michell Kim

Data sourced from clinicaltrials.gov

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