Effectiveness of Virtual Reality (VR) in the Management of Anxiety for Patients Undergoing Radiotherapy (RELAX)

Effectiveness of Virtual Reality in the Management of Anxiety for Patients Undergoing Radiotherapy

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.

Study Overview

• Status: Recruiting
• Conditions: Virtual Reality; Radiation Therapy
• Intervention / Treatment: Other: standard of care; Other: Virtual Reality Intervention; Other: Radiation Therapist Survey

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 Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sheri Whittington; Phone Number: 336-878-6107; Email: Sheri.Whittington@Advocatehealth.org

Study Locations

• United States
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Recruiting
      • Atrium Health Wake Forest Baptist Hayworth Cancer Center
      • Contact: Sheri Whittington; Phone Number: 336-878-6107; Email: Sheri.Whittington@Advocatehealth.org
      • Principal Investigator: Stephanie Parker, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Patients:

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 0-3 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard of care; Standard of care radiation therapy for prostate, lung, breast cancer without using the VR headset	Other: standard of care; Radiation therapy for prostate cancer, breast cancer, lung cancer, or head and neck cancer.
Other: Virtual Reality intervention; Participants will wear the VR headset (Quest 2 by Meta) during radiation therapy	Other: standard of care; Radiation therapy for prostate cancer, breast cancer, lung cancer, or head and neck cancer.; Other: Virtual Reality Intervention; Participants will wear the VR headset (Meta Quest 2) during standard of care radiation therapy
Other: Radiation Therapists; Providers that administer the VR intervention	Other: Radiation Therapist Survey; Radiation therapists will be asked about their experiences and proficiency with using the VR device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Periprocedural (each treatment visit)
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; = device functional for part but not all of the treatment duration; = device was functional for the duration of the treatment	Periprocedural (each treatment visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	GAD-7: Baseline RTEQ: Periprocedural (After first and last treatment)
Acceptability of Implementing VR	Radiation Therapist Survey (Administered to staff only)	At 36 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Periprocedural (each treatment visit)
Anxiety - Change over the course of treatment	Single Item Anxiety Questionnaire	Periprocedural (first treatment, last treatment, weekly during treatment)
Anxiety - Change over the course of treatment	Anxiety evaluation with heart rate	Periprocedural (first treatment, last treatment, weekly during treatment)
Participant Satisfaction	VR Satisfaction Questionnaire	4-6 weeks following randomization

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Atrium Health Wake Forest Baptist
• Investigators: Principal Investigator: Stephanie Parker, MS, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: December 30, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Cancer; Virtual Reality; Radiation Therapy
• Additional Relevant MeSH Terms: Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: IRB00140668; P30CA012197 (U.S. NIH Grant/Contract); ONC-LUN-2407 (Other Identifier: Atrium Health Wake Forest Baptist Comprehensive Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No