Effectiveness of Virtual Reality (VR) in the Management of Anxiety for Patients Undergoing Radiotherapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
standard of care
Other interventionRadiation therapy for prostate cancer, breast cancer, lung cancer, or head and neck cancer.
Virtual Reality Intervention
Other interventionParticipants will wear the VR headset (Meta Quest 2) during standard of care radiation therapy
Radiation Therapist Survey
Other interventionRadiation therapists will be asked about their experiences and proficiency with using the VR device.
Treatment groups
54 Participants
are divided into 3 treatment groupsGroup A: Standard of careOther 1 intervention
Group B: Virtual Reality interventionOther 2 interventions
Group C: Radiation TherapistsOther 1 intervention
Trial outcomes
Primary outcomes
1
VR Use During Treatment
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.
Time frame
Periprocedural (each treatment visit)2
VR Functionality
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
Time frame
Periprocedural (each treatment visit)Secondary outcomes
1
Anxiety - Change over time
Generalized Anxiety Disorder 7-item (GAD-7) to assess pre-existing generalized anxiety and the 23-item Radiotherapy Experience Questionnaire (RTEQ) situational unease and situational repose subscales.
Time frame
GAD-7: Baseline RTEQ: Periprocedural (After first and last treatment)2
Acceptability of Implementing VR
Radiation Therapist Survey (Administered to staff only)
Time frame
At 36 monthsOther outcomes
1
Incidence of Treatment - Treatment Related Adverse Events
Total counts and grade of symptoms such as nausea, dizziness, seizures, blurred vision, fatigue, eye or muscle twitching, instability in posture, blackouts triggered by light flashes or patterns, and headache.
Time frame
Periprocedural (each treatment visit)2
Anxiety - Change over the course of treatment
Single Item Anxiety Questionnaire
Time frame
Periprocedural (first treatment, last treatment, weekly during treatment)3
Anxiety - Change over the course of treatment
Anxiety evaluation with heart rate
Time frame
Periprocedural (first treatment, last treatment, weekly during treatment)4
Participant Satisfaction
VR Satisfaction Questionnaire
Time frame
4-6 weeks following randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Wake Forest University Health Sciences
Lead sponsor
Atrium Health Wake Forest Baptist
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov