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

Wake Forest University (WFU)

Status: Begins enrollment in 2 months

Conditions: Radiation Therapy; Virtual Reality

Treatments: Other: standard of care; Other: Radiation Therapist Survey; Other: Virtual Reality Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07324577

IRB00140668

ONC-LUN-2407 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 3 patient groups

Standard of care

Other group

Description:

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

Treatment:

Other: standard of care

Virtual Reality intervention

Other group

Description:

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

Treatment:

Other: Virtual Reality Intervention

Other: standard of care

Radiation Therapists

Other group

Description:

Providers that administer the VR intervention

Treatment:

Other: Radiation Therapist Survey