Virtual Reality for Anxiety During Cancer Treatment

(RADIOACTIVE Trial)

Overseen By Benjamin J Rich, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Prior radiation, Pregnant, Impaired decision-making, others

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

Compensation: Varies

Number of Visits: 1

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how virtual reality can reduce anxiety for people undergoing radiotherapy. Participants will use a virtual reality headset to experience the treatment process from different perspectives, such as through a First-Person Virtual Reality Video or a Third-Person Virtual Reality Video, or they will watch a standard informational video. The goal is to identify the most effective method to make the treatment experience less stressful and more satisfying. People with a confirmed cancer diagnosis who are receiving radiotherapy and can speak English or Spanish might be suitable candidates. As an unphased trial, this study offers a unique opportunity to explore innovative ways to enhance the treatment experience.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that these virtual reality techniques are safe for reducing anxiety during cancer treatment?

Research has shown that virtual reality (VR) is generally safe for cancer patients. Studies indicate that VR can reduce anxiety and improve the treatment experience. Patients using VR often report positive experiences, with only occasional mild discomfort such as dizziness or nausea. Both first-person and third-person VR views are popular, helping patients feel less anxious and more engaged during treatment. Overall, VR appears to be a promising tool with a good safety record for supporting patients through their cancer journey. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) to manage anxiety during cancer treatment because it offers a fresh way to help patients feel more at ease. Unlike traditional methods like counseling or medication, VR immerses patients in an environment that can distract and calm them during stressful procedures. The first-person VR experience lets patients feel as if they’re going through the treatment themselves in a controlled, virtual setting, which can make the real experience less intimidating. Meanwhile, the third-person VR perspective allows patients to observe the treatment process from outside their own body, providing a sense of detachment that can reduce anxiety. These innovative approaches could transform how we support patients emotionally during cancer treatment, offering a more engaging and personalized experience.

What evidence suggests that this trial's virtual reality treatments could be effective for reducing anxiety during cancer treatment?

This trial will compare different virtual reality (VR) experiences to reduce anxiety during cancer treatment. Participants may receive a first-person VR experience, which studies have shown can effectively reduce anxiety, pain, and stress by immersing patients in the treatment process. Alternatively, some participants will experience VR from a third-person perspective, which early findings suggest can improve emotional wellbeing and decrease fear and distress. Patients have well-received both types of VR, with many reporting increased satisfaction and reduced anxiety. Overall, researchers recognize VR as a helpful tool in making cancer treatment less stressful. ^{1 2 6 7 8}

Who Is on the Research Team?

Benjamin J Rich, MD

Principal Investigator

University of Miami

Crystal Chen, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for individuals undergoing radiotherapy who may experience anxiety. It's open to those willing to try virtual reality as part of their education about the treatment process. Specific eligibility details are not provided, so it's best to contact the study team for more information.

Inclusion Criteria

I can speak and read English or Spanish.

I am getting radiotherapy at the University of Miami.

My cancer was confirmed through a tissue examination.

Exclusion Criteria

I am unwilling to complete survey forms.

Patients unable to consent or are prisoners

I have had radiation therapy before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Radiotherapy Education

Participants experience virtual reality or watch an informational video to understand the radiotherapy process

up to 8 weeks

1 visit (in-person) for VR setup or video viewing

Follow-up

Participants are monitored for changes in knowledge, quality of life, and anxiety levels

up to 8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• First-Person Virtual Reality Video
• Third-Person Virtual Reality Video
• Two Dimensional (2D) Informational Video

Trial Overview The study compares three types of educational content: a third-person VR video, a first-person VR video, and a standard 2D informational video. The goal is to see if VR can help reduce anxiety and increase satisfaction with radiotherapy treatment.

How Is the Trial Designed?

Group I: Virtual Reality: 3rd Person Perspective Experimental Treatment 1 Intervention

Participants in this group will wear a Meta Quest Pro virtual reality headset and use virtual reality to observe the radiation treatment scenario from a standing position within the room, enabling them to witness both the CT scan and radiation machine from an external viewpoint. Total participation is up to 8 weeks.

Group II: Virtual Reality: 1st Person Perspective Experimental Treatment 1 Intervention

Participants in this group will have a virtual reality experience presented from a first-person perspective. Participants will wear a Meta Quest Pro virtual reality headset, immersing themselves in a scenario that replicates the radiation treatment process. Total participation is up to 8 weeks.

Group III: Informational Video Active Control 1 Intervention

Participants in this group will watch a two-dimensional (2D) informational video that explains the radiation treatment process. Total participation is up to 8 weeks.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Published Research Related to This Trial

The study involved 60 patients undergoing radiotherapy, where those using a virtual reality (VR) educational system showed a significant reduction in anxiety levels and improved understanding of the treatment compared to a control group that received standard care.

Post-intervention, the VR group experienced a notable decrease in systolic blood pressure and an increase in cognitive scores, indicating that VR education can effectively enhance patient comprehension and alleviate anxiety before treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Study of a Virtual Reality Educational Intervention for Radiotherapy Patients Prior to Initiating Treatment. Gao, J., Liu, S., Zhang, S., et al.[2022]

A systematic review of nine studies on the use of immersive virtual reality (VR) for pain and anxiety management in cancer patients showed a trend towards improvement, but only two studies demonstrated statistically significant results.

The current evidence is inconclusive due to methodological limitations and small sample sizes, highlighting the need for further research to better understand the effectiveness of VR in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Virtual Reality Therapy in Reducing Pain and Anxiety for Cancer-Related Medical Procedures: A Systematic Narrative Review. Chow, H., Hon, J., Chua, W., et al.[2021]

A systematic review of 6 studies involving 453 cancer patients undergoing chemotherapy found that virtual reality (VR) interventions did not show significant differences in reducing treatment-related anxiety and fatigue compared to control conditions.

The overall quality of the studies was low, with limitations such as small sample sizes and varying study designs, making it difficult to draw clear conclusions about the effectiveness of VR as a distraction during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality as a chemotherapy support in treatment of anxiety and fatigue in patients with cancer: A systematic review and meta-analysis and future research directions. Rutkowski, S., Czech, O., Wrzeciono, A., et al.[2022]

A virtual reality application designed for patients undergoing radiotherapy significantly improved understanding of the treatment, with 74% of participants reporting a better grasp of their radiotherapy plan after the VR experience.

The VR session also helped reduce anxiety in 57% of patients who initially felt anxious about their treatment, suggesting that this technology could be an effective educational tool for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality-Based Education for Patients Undergoing Radiation Therapy. Wang, LJ., Casto, B., Luh, JY., et al.[2022]

The study involving 19 pediatric cancer patients showed that immersive virtual reality significantly reduced anxiety and acute nausea during their first chemotherapy sessions, indicating its potential effectiveness as a supportive intervention.

The high consent and low withdrawal rates suggest that immersive virtual reality is not only feasible but also well-accepted by patients, parents, and healthcare providers in a clinical setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of immersive virtual reality for managing anxiety, nausea and vomiting among paediatric cancer patients receiving their first chemotherapy: An exploratory randomised controlled trial. Lee Wong, C., Li, CK., Choi, KC., et al.[2022]

A review of 13 studies on virtual reality (VR) technology for managing pain and anxiety in cancer patients found that VR, when combined with standard care, is more effective than standard care alone, particularly for children, adolescents, and hospitalized adults undergoing treatment.

The studies included were generally of good or fair quality, but more high-quality research is needed to fully establish the effectiveness of VR as a treatment option for pain and anxiety in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Technology for Pain and Anxiety Management among Patients with Cancer: A Systematic Review. Ahmad, M., Bani Mohammad, E., Anshasi, HA.[2021]

Virtual Reality (VR) significantly reduced anxiety in cancer patients undergoing chemotherapy, with a mean difference of -6.57 compared to standard care, although the evidence quality was very low due to high variability among studies.

The review included 459 patients across four randomized controlled trials and four crossover studies, highlighting the need for more robust research to clarify the effectiveness of VR on anxiety, fatigue, and pain in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of immersive virtual reality on anxiety, fatigue and pain in patients with cancer undergoing chemotherapy: A systematic review and meta-analysis. Burrai, F., Sguanci, M., Petrucci, G., et al.[2023]

The study developed an affordable smartphone-based virtual reality (VR) platform that effectively reduces patient anxiety during radiation therapy, with participants reporting a decrease in anxiety after watching VR videos depicting their treatment process.

Patients found the VR experience helpful, with 96.4% of Group A and 90.9% of Group B appreciating the VR aspect, indicating that this innovative approach can enhance patient comfort and understanding of their treatment journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Affordable Platform for Virtual Reality-Based Patient Education in Radiation Therapy. Schulz, JB., Dubrowski, P., Blomain, E., et al.[2023]

Virtual reality (VR) is a feasible and acceptable tool for patient education in healthcare, particularly effective in improving patients' knowledge about their illnesses and satisfaction with treatment, as evidenced by 18 studies primarily involving cancer patients.

While VR shows promise in enhancing communication of medical information, further research is needed to explore its effectiveness across different patient populations and to understand any potential unintended consequences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality as a patient education tool in healthcare: A scoping review. van der Kruk, SR., Zielinski, R., MacDougall, H., et al.[2022]

Citations

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Virtual Reality for Anxiety During Cancer Treatment The studies reviewed indicate that virtual reality (VR) interventions are generally safe and can effectively reduce anxiety in cancer patients undergoing ...

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Cancer patients' acceptance of virtual reality interventions ... This study investigates the acceptability of Virtual reality (VR) technology for emotional regulation among cancer patients.