Virtual Reality for Anxiety in Cancer Patients

(RELAX Trial)

Overseen By Sheri Whittington

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Previous radiation, Brain tumors, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how virtual reality (VR) might ease anxiety during radiation therapy for cancer patients. It focuses on individuals receiving treatment for prostate, breast, lung, or head and neck cancer. Participants will either receive standard care or wear a VR headset during their sessions as part of the Virtual Reality Intervention. This trial suits patients scheduled for at least 15 radiation treatments who have not previously undergone radiation therapy. As an unphased trial, it offers patients the chance to explore innovative ways to enhance their treatment experience.

What prior data suggests that this virtual reality intervention is safe for cancer patients?

Research has shown that virtual reality (VR) is generally safe for cancer patients. In a clinical trial, VR helped lower anxiety and stress in these patients. Another study found that patients felt comfortable using VR, which helped manage their emotional symptoms. No major reports of negative side effects have emerged from using VR in these situations.

While more research is always useful, current evidence suggests that VR use during cancer treatments is safe for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) for anxiety relief in cancer patients because it offers a new and immersive way to potentially ease stress during treatments like radiation therapy. Unlike traditional methods, which might include medications or talk therapy, VR provides a distraction and calming experience by immersing patients in a virtual world through a headset. This innovative approach can make radiation sessions more comfortable and less anxiety-inducing, potentially improving overall patient experience and adherence to treatment.

What evidence suggests that virtual reality is effective for anxiety in cancer patients?

Research shows that virtual reality (VR) can help reduce anxiety and stress in cancer patients. In this trial, one group of participants will wear a VR headset during radiation therapy, while another group will receive standard care without the VR intervention. Some studies have found that using VR during treatments like chemotherapy can make patients feel less distressed. Other research highlights VR's benefits in reducing anxiety and pain and improving the overall quality of life for cancer patients. By placing patients in soothing virtual settings, VR distracts them from their real-world surroundings, making the treatment experience more comfortable. While more research is needed, these findings suggest VR could be a promising tool for managing anxiety in cancer care. ^{1 5 6 7 8}

Who Is on the Research Team?

Stephanie Parker, MS

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for patients with prostate, breast, lung, or head and neck cancer who are undergoing radiation therapy. Specific eligibility criteria details were not provided.

Inclusion Criteria

Ability to understand and the willingness to sign an IRB-approved informed consent document directly

I am scheduled for 15 or more radiation therapy sessions for cancer in the prostate, breast, lung, or head and neck.

I am 18 years old or older.

Exclusion Criteria

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

I have had radiation therapy before.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive radiation therapy with or without the VR device. Assessments occur before and after the first treatment, every 6th treatment, and at the end of treatment.

Varies based on individual treatment plans

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including anxiety assessments and VR satisfaction.

4-6 weeks following randomization

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality Intervention

Trial Overview

The study aims to assess the effectiveness of using Virtual Reality (VR) interventions to manage anxiety in patients during their radiation treatments compared to standard care.

How Is the Trial Designed?

Group I: Virtual Reality intervention Experimental Treatment 2 Interventions

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

Group II: Standard of care Experimental Treatment 1 Intervention

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

Group III: Radiation Therapists Experimental Treatment 1 Intervention

Providers that administer the VR intervention

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Atrium Health Wake Forest Baptist

Collaborator

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11789450/

Effectiveness of virtual reality in cancer patients ...

The studies analyzed show that virtual reality shows positive results in pain reduction, anxiety, stress and asthenia. However, more studies ...

2.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.11052

Evaluating the effectiveness of immersive virtual reality in ...

The primary outcome was to evaluate the effectiveness of VR in reducing distress levels while receiving chemotherapy infusion (NCCN Distress ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07088367

Virtual Reality Meditation on Anxiety in Cancer Patients ...

Does VR meditation, delivered through virtual reality glasses and the MediboothVR application, effectively reduce anxiety in cancer patients during chemotherapy ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S1462388923000741

Effectiveness of immersive virtual reality on anxiety, fatigue ...

This systematic review and meta-analysis aimed to assess the effectiveness of Virtual Reality on anxiety, fatigue and pain in patients with cancer during ...

5.

jpsmjournal.com

jpsmjournal.com/article/S0885-3924(23)00053-2/fulltext

A Systematic Review and Meta-Analysis

This study aimed to assess the effects of VR-based interventions on anxiety, pain, depression, fear, distress, and quality of life in cancer patients.

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S2352013225001644

The use of virtual reality in cancer patient health education

With advancements in medical technology, virtual reality (VR) has emerged as an effective tool for enhancing cancer patient health education [13] ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07221409

Study Details | NCT07221409 | Virtual Reality Intervention ...

This clinical trial tests the safety, tolerability, and effectiveness of a virtual reality intervention to improve psychological symptom burden ...

8.

nature.com

nature.com/articles/s41598-025-95160-1

Cancer patients' acceptance of virtual reality interventions ...

This study investigates the acceptability of Virtual reality (VR) technology for emotional regulation among cancer patients.