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

NCT07324577 | Not Yet Recruiting DMC

• 2 other identifiers: IRB00140668ONC-LUN-2407
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Therapy; Virtual Reality

Keywords

Virtual Reality; Cancer; Radiation Therapy

Outcome Measures

Primary Outcomes (2)

• 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 1. = device functional for part but not all of the treatment duration 2. = device was functional for the duration of the treatment

  Periprocedural (each treatment visit)

Secondary Outcomes (2)

• Anxiety - Change over time

  GAD-7: Baseline RTEQ: Periprocedural (After first and last treatment)

• Acceptability of Implementing VR

  At 36 months

Other Outcomes (4)

• Incidence of Treatment - Treatment Related Adverse Events

  Periprocedural (each treatment visit)

• Anxiety - Change over the course of treatment

  Periprocedural (first treatment, last treatment, weekly during treatment)

• Anxiety - Change over the course of treatment

  Periprocedural (first treatment, last treatment, weekly during treatment)

Study Arms (3)

Standard of care

OTHER

Standard of care radiation therapy for prostate, lung, breast cancer without using the VR headset

Other: standard of care

Virtual Reality intervention

OTHER

Participants will wear the VR headset (Quest 2 by Meta) during radiation therapy

Other: standard of care; Other: Virtual Reality Intervention

Radiation Therapists

OTHER

Providers that administer the VR intervention

Other: Radiation Therapist Survey

Interventions

standard of care OTHER

Radiation therapy for prostate cancer, breast cancer, lung cancer, or head and neck cancer.

Standard of care; Virtual Reality intervention

Virtual Reality Intervention OTHER

Participants will wear the VR headset (Meta Quest 2) during standard of care radiation therapy

Virtual Reality intervention

Radiation Therapist Survey OTHER

Radiation therapists will be asked about their experiences and proficiency with using the VR device.

Radiation Therapists

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Atrium Health Wake Forest Baptist: collaborator

Study Sites (1)

Atrium Health Wake Forest Baptist Hayworth Cancer Center

High Point, North Carolina, 27262, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Stephanie Parker, MS

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheri Whittington

CONTACT

336-878-6107; Sheri.Whittington@Advocatehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: January 7, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)