Clinical trial NCT06318338: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Virtual Reality
Relaxation
Mindfulness
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of a pre-simulation VR platform prior to radiation
timeFrame: 12 months
Secondary outcomes:
measure: Patient feedback on pre-simulation VR program
timeFrame: 12 months
measure: Patient situational anxiety prior to and after use of VR program (HADS)
timeFrame: 12 months
measure: Patient situational anxiety prior to and after use of VR program (STAI-6)
timeFrame: 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Perelman Center for Advanced Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Michael LaRiviere, MD
role: PRINCIPAL_INVESTIGATOR
References: