Effectiveness of Virtual Reality in the Management of Anxiety for Patients Undergoing Radiotherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- VR Use During Treatment
Study Overview
Brief Summary
The purpose of this study is to evaluate the use and functionality of virtual reality (VR) during radiation therapy treatments for patients with prostate, breast, lung, or head and neck cancer.
Detailed Description
This is a randomized controlled trial that will assess the feasibility, acceptability, tolerability, and initial clinical efficacy of using a VR device during radiation therapy for participants with prostate cancer, breast cancer, lung cancer, or head and neck cancer.
Participants will be randomized 2:1 to either the VR device intervention arm or the standard of care control arm.
Participants will undergo pre-study assessments, assessments before and after the first radiation treatment, every 6th radiation treatment, and at the end of treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inclusion Criteria:
- •Participants planned for radiation therapy for 15 or more treatments with non-neutron generating energies (10 MV or less) per study PI for prostate, breast, lung, or head and neck cancer. Neutrons have the potential to damage the VR headset device and are generated for energies above 10 MV.
- •Age 18 years or older at the time of consent.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-33 or Karnofsky (KPS) 30-100 at the time of enrollment.
- •Ability to understand and the willingness to sign an IRB-approved informed consent document directly.
Exclusion Criteria
- •Previous radiation therapy
- •VR device is determined to impede the radiation dosage during the VR device simulation and treatment planning
- •Participants with primary brain tumors, brain metastases, and cancer involving the sinuses, orbits, nose, or ears, are excluded from this clinical trial because the VR device may obstruct the area being treated
- •Participants with uncontrolled inter-current illness including but not limited to psychiatric illness/social situations that would limit compliance with study requirements per treating radiation oncologist.
- •Participants with known epilepsy, significant motion sickness, severe uncorrected visual impairment, severe uncorrected hearing impairment, or seizures, per participant report.
- •Participants with skin defects, infections, or open wounds in the area where the VR device is applied (face or scalp) or in the eyes per treating radiation oncologist.
- •Participants with pacemakers, internal defibrillators, hearing aid, or other implanted medical device. The Meta Quest device contains magnets and components that emit magnetic/electromagnetic fields which could affect the operation of nearby electronics and medical devices.
- •Radiation Therapists:
- •Inclusion Criteria:
- •Agreement to participate after reviewing the information sheet
- •Radiation therapist at AHWFBCCC High Point who has treated at least one participant who enrolled on to the study and used the VR device.
Arms & Interventions
Virtual Reality intervention
Participants will wear the VR headset (Quest 2 by Meta) during radiation therapy
Intervention: standard of care (Other)
Standard of care
Standard of care radiation therapy for prostate, lung, breast cancer without using the VR headset
Intervention: standard of care (Other)
Virtual Reality intervention
Participants will wear the VR headset (Quest 2 by Meta) during radiation therapy
Intervention: Virtual Reality Intervention (Other)
Radiation Therapists
Providers that administer the VR intervention
Intervention: Radiation Therapist Survey (Other)
Outcomes
Primary Outcomes
VR Use During Treatment
Time Frame: Periprocedural (each treatment visit)
A binary variable (Yes/No) will be created for participants at the level of individual treatment visit to signify whether the participants wore the VR device for the duration of their treatment.
VR Functionality
Time Frame: Periprocedural (each treatment visit)
VR device functionality (0-2) will be determined at the level of individual treatment visit using the following criteria as determined by the participant and/or treatment staff: 0 = device not functional at any time during the treatment 1. = device functional for part but not all of the treatment duration 2. = device was functional for the duration of the treatment
Secondary Outcomes
- Anxiety - Change over time(GAD-7: Baseline RTEQ: Periprocedural (After first and last treatment))
- Acceptability of Implementing VR(At 36 months)