Virtual reality to reduce anxiety during radiation therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial will compare a virtual reality (VR) device used during radiation therapy to standard care, with participants randomized 2:1 to the VR or control arm. The study will measure feasibility, acceptability, tolerability, and initial clinical effects on anxiety with assessments before and after the first treatment, every sixth treatment, and at the end of the radiation course. Eligible adults are those planned for 15 or more radiation treatments using non-neutron-generating energies (≤10 MV) with ECOG performance status 0–3, excluding people with prior radiation or tumors that would be obstructed by the headset. The trial is led by Wake Forest University Health Sciences and conducted at Atrium Health Wake Forest Baptist Hayworth Cancer Center in High Point, North Carolina.

Why it matters

Who can join: the full rules

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.

Where it's running

• Atrium Health Wake Forest Baptist Hayworth Cancer Center
  High Point, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Stephanie Parker, MS — Wake Forest University Health Sciences
• Study coordinator: Sheri Whittington
• Email: Sheri.Whittington@Advocatehealth.org
• Phone: 336-878-6107

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.