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

NCT ID: NCT07324577

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-05-31
• Study Completion Date: 2029-02-01

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.

Conditions

Radiation Therapy; Virtual Reality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard of care

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

Group Type: OTHER

standard of care

Intervention Type: OTHER

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

Virtual Reality intervention

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

Group Type: OTHER

standard of care

Intervention Type: OTHER

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

Virtual Reality Intervention

Intervention Type: OTHER

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

Radiation Therapists

Providers that administer the VR intervention

Group Type: OTHER

Radiation Therapist Survey

Intervention Type: OTHER

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

Interventions

standard of care

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

Intervention Type: OTHER

Virtual Reality Intervention

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

Intervention Type: OTHER

Radiation Therapist Survey

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

Intervention Type: OTHER

Eligibility 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 0-3 at the time of enrollment.
• Ability to understand and the willingness to sign an IRB-approved informed consent document directly.

• 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.

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:

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atrium Health Wake Forest Baptist

OTHER

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephanie Parker, MS

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Atrium Health Wake Forest Baptist Hayworth Cancer Center

High Point, North Carolina, United States

Countries

United States

Central Contacts

Sheri Whittington

Role: CONTACT

Sheri.Whittington@Advocatehealth.org

336-878-6107

Facility Contacts

Sheri Whittington

Role: primary

Sheri.Whittington@Advocatehealth.org

336-878-6107

Other Identifiers

IRB00140668

Identifier Type: -

Identifier Source: org_study_id

ONC-LUN-2407

Identifier Type: OTHER

Identifier Source: secondary_id