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Recruiting NCT07324577

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

No phase Interventional Radiation Therapy Virtual Reality

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: standard of care, Virtual Reality Intervention, Radiation Therapist Survey.
Who it may be relevant to
Registry conditions: Radiation Therapy, Virtual Reality. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • VR Use During Treatment [Time frame: Periprocedural (each treatment visit)]
  • VR Functionality [Time frame: Periprocedural (each treatment visit)]
Secondary outcome measures (2)
  • Anxiety - Change over time [Time frame: GAD-7: Baseline RTEQ: Periprocedural (After first and last treatment)]
  • Acceptability of Implementing VR [Time frame: At 36 months]

Eligibility 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 0-33 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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Atrium Health Wake Forest Baptist Hayworth Cancer Center — High Point

Identifiers

NCT: NCT07324577 · IRB00140668 · P30CA012197 · ONC-LUN-2407

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗