Virtual Reality for Cervical Cancer Comfort During Brachytherapy

Overseen By Matthew R Kovak

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Arkansas

Disqualifiers: Seizure disorder, Motion sickness, Migraine, others

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

Compensation: Varies

Number of Visits: 4

Duration: 3 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a virtual reality (VR) headset can make cervical cancer treatments more comfortable. It examines how VR might reduce pain and anxiety during brachytherapy, a type of radiation treatment. Participants may use VR during various treatment visits to assess its impact on their experience. Women with gynecologic cancer, such as cervical cancer, who require specific radiation treatments could be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to explore innovative methods to enhance treatment comfort and experience.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial team or your doctor.

What prior data suggests that the Oculus Quest 2 Virtual Reality Headset is safe for use during brachytherapy?

Research has shown that virtual reality (VR) can reduce anxiety, pain, and stress in cancer patients. Most patients feel safe using VR equipment. Reports have not indicated infections or major side effects from VR use in similar situations. Many studies suggest that VR can enhance patients' perceptions of their pain. Therefore, the Oculus Quest 2 VR headset appears safe and effective in increasing patient comfort during treatments like brachytherapy for cervical cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) with the Oculus Quest 2 headset during brachytherapy for cervical cancer because it offers a unique way to enhance patient comfort. Current treatments mostly focus on the physical aspects of the cancer itself, but this VR approach aims to reduce anxiety and discomfort by immersing patients in a different environment during treatment. This distraction technique is non-invasive and can be easily integrated into existing treatment protocols without interfering with the medical procedures. By potentially improving the overall experience for patients undergoing brachytherapy, VR could make a significant difference in how patients feel during and after their treatments.

What evidence suggests that using the Oculus Quest 2 Virtual Reality Headset is effective for improving comfort during cervical cancer brachytherapy?

Research has shown that virtual reality (VR) can reduce anxiety, depression, and pain in cancer patients. Studies indicate that VR effectively lowers stress and increases comfort during medical procedures. In cancer care, VR has decreased anxiety and pain, suggesting it might also assist during brachytherapy for cervical cancer. In this trial, participants will use the Oculus Quest 2 VR headset as a distraction tool during specific visits, potentially improving patient satisfaction and reducing the need for pain and anxiety medications. Overall, VR offers a promising way to make cancer treatments more comfortable. ^{1 2 3 6 7}

Who Is on the Research Team?

Gary Lewis, MD

Principal Investigator

University of Arkansas

Are You a Good Fit for This Trial?

This trial is for women aged 18 or older with a confirmed diagnosis of gynecologic cancer (like cervical cancer) that requires brachytherapy. Participants must be able to give written consent. It's not suitable for those with certain phobias, severe vision or hearing issues, history of seizures or motion sickness due to visual triggers, or any condition that would interfere with wearing a VR headset.

Inclusion Criteria

I have a gynecologic cancer that needs specific radiation therapy.

I am a woman and 18 years old or older.

Able to provide written consent

Exclusion Criteria

I have a history of high eye pressure.

I have a history of seizures, severe motion sickness, dizziness, or migraines triggered by visual disturbances.

I do not have claustrophobia, thalassophobia, cleithrophobia, or similar fears.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo four rounds of brachytherapy with and without VR distraction

3 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• The Oculus Quest 2 Virtual Reality Headset

Trial Overview The study tests if using the Oculus Quest 2 Virtual Reality Headset during brachytherapy can improve patient satisfaction and reduce pain and the need for painkillers or anxiety medication. The goal is also to see how well VR technology fits into the clinical routine.

How Is the Trial Designed?

Group I: Sequence Group D Experimental Treatment 1 Intervention

VR distraction occurring visits 2 and 3 with normal SOC therapy at visits 3 and 4.

Group II: Sequence Group C Experimental Treatment 1 Intervention

VR distraction occurring visits 3 and 4 with normal SOC therapy at visits 1 and 2.

Group III: Sequence Group B Experimental Treatment 1 Intervention

VR distraction occurring visits 1 and 4 with normal SOC therapy at visits 2 and 3.

Group IV: Sequence Group A Experimental Treatment 1 Intervention

VR distraction occurring visits 1 and 2 with normal SOC therapy at visits 3 and 4.

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

Published Research Related to This Trial

In a study of 35 patients undergoing cervical brachytherapy, using virtual reality (VR) for distraction during applicator removal resulted in comparable levels of anxiety and pain to those experienced with nitrous oxide (N2O) sedation, suggesting VR could be a viable alternative.

While the VR group reported slightly higher anxiety levels during the procedure, they experienced lower peak pain scores compared to the N2O group, indicating that VR can effectively manage discomfort, although some patients did report mild side effects like nausea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality distraction during uterovaginal brachytherapy applicators' removal: A pilot comparative study. Varnier, R., Brière, O., Brouillard, T., et al.[2021]

A high-fidelity, ultrasound- and CT-compatible gynecologic brachytherapy training simulator was successfully developed to enhance the training of residents, addressing the need for better procedural fidelity in training models.

The simulator's realistic features, such as a cervical os and palpable tumor, aim to improve the proficiency of brachytherapists, potentially leading to better treatment outcomes and survival rates for women with advanced gynecologic cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new development in ultrasound-compatible gynecologic brachytherapy simulators. Fields, EC., Joyner, MM., Singer, L., et al.[2021]

In a study involving 90 oncology patients aged 7-19, Immersive Virtual Reality (VR) showed a greater positive impact on mood states compared to an iPad control, with patients reporting improved mood and reduced negative symptoms.

While both interventions were beneficial, the effectiveness of VR was influenced by factors such as the child's illness severity, age, sex, and level of immersion, suggesting that these elements should be considered in future applications of VR in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the use of Immersive Virtual Reality to enhance Psychological Well-Being in Pediatric Oncology: A pilot randomized controlled trial. Tennant, M., Youssef, GJ., McGillivray, J., et al.[2021]

Virtual reality (VR) interventions have been shown to significantly reduce symptoms of anxiety, depression, pain, and fatigue in cancer patients, based on a meta-analysis of 6 studies.

The findings suggest that while VR is effective for managing acute symptoms during cancer treatment, further research is needed to explore its benefits for long-term side effects in cancer survivorship care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-Analysis of the Efficacy of Virtual Reality-Based Interventions in Cancer-Related Symptom Management. Zeng, Y., Zhang, JE., Cheng, ASK., et al.[2020]

In a pilot study involving 30 adolescents with cancer undergoing lumbar punctures, the use of virtual reality (VR) glasses showed a trend towards lower pain scores compared to a control group, although the difference was not statistically significant.

77% of the adolescents using VR reported that it helped distract them from the procedure, suggesting that VR could be a useful nonpharmacologic tool for pain management during painful medical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of distraction using virtual reality glasses during lumbar punctures in adolescents with cancer. Sander Wint, S., Eshelman, D., Steele, J., 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]

Radiation therapy, particularly image-guided adaptive brachytherapy, is crucial for treating locally advanced cervical and vaginal cancers, as it allows for higher doses to the tumor while protecting surrounding healthy tissues.

The use of 3D-printed applicators in brachytherapy is becoming more common, addressing limitations of standard applicators by providing customized solutions that improve target volume coverage in patients with complex anatomical challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of 3D Printing Technology in Gynaecological Brachytherapy-A Narrative Review. Segedin, B., Kobav, M., Zobec Logar, HB.[2023]

A new method for image-guided catheter placement in high dose rate (HDR) brachytherapy for gynecologic cancers has been developed, showing a targeting error of less than 2.9mm, which is comparable to existing clinical navigation systems.

This technology aims to improve the accuracy of catheter placement, potentially maximizing tumor coverage while minimizing damage to surrounding organs like the bladder and rectum, enhancing the safety and efficacy of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EM-Navigated Catheter Placement for Gynecologic Brachytherapy: An Accuracy Study. Mehrtash, A., Damato, A., Pernelle, G., et al.[2021]

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 virtual reality relaxation intervention was found to be feasible and acceptable for patients with primary brain tumors, with 50% enrollment from those approached and high satisfaction reported by 90% of participants.

The intervention had a low incidence of mild adverse effects (7 cases), indicating it is a safe option for managing distress and anxiety during neuroimaging procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a virtual reality intervention targeting distress and anxiety symptoms in patients with primary brain tumors: Interim analysis of a phase 2 clinical trial. King, AL., Roche, KN., Leeper, HE., et al.[2023]

A study involving 14 residents showed that virtual reality (VR) training for intracavitary brachytherapy significantly improved their self-confidence and technical skills, with confidence scores rising from 1.43 to 3.36 after the simulation.

Residents also completed the procedure faster, with average implant times decreasing from 5:51 to 3:34 minutes, indicating that VR training not only enhances confidence but also improves efficiency in performing brachytherapy procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality-based simulation improves gynecologic brachytherapy proficiency, engagement, and trainee self-confidence. Taunk, NK., Shah, NK., Hubley, E., et al.[2021]

A study involving 123 adults undergoing chemotherapy found that using virtual reality (VR) as a distraction made the treatment feel shorter and was generally well-received, with 82% of participants expressing a desire to use it again.

Despite the positive feedback on the VR experience, the intervention did not significantly reduce symptom distress immediately or two days after chemotherapy, indicating that while VR can enhance the treatment experience, it may not alleviate chemotherapy-related symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality: a distraction intervention for chemotherapy. Schneider, SM., Hood, LE.[2018]

Citations

1. withpower.com withpower.com/trial/phase-endocervical-cancer-6-2022-f83b6

Virtual Reality for Cervical Cancer Comfort During ... Research shows that virtual reality (VR) can help reduce anxiety, depression, and pain in cancer patients, suggesting it might also help improve comfort during ...

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

Effectiveness of virtual reality in cancer patients ... Virtual reality has proven to be an effective technique in reducing the anxiety, pain, asthenia and stress suffered by patients diagnosed with cancer and ...

3. frontiersin.org frontiersin.org/journals/virtual-reality/articles/10.3389/frvir.2022.1000035/pdf

Comparison of virtual reality platforms to enhance medical ... This pilot study compared educational and cost effectiveness of low-cost cardboard viewer VR (CVVR) and commercially available integrated ...

4. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/348955

Using Virtual Reality Technology to Improve Patient ... The secondary objective is to determine if VR distraction during brachytherapy treatment for cervical cancer improves subjects' satisfaction, procedural/acute ...

5. brachyjournal.com brachyjournal.com/article/S1538-4721(23)01602-1/abstract

Virtual reality technology: A potential tool to enhance ... Analysis of applicator insertion related acute side effects for cervical cancer treated with brachytherapy ... Immerse, interact and iterate: virtual reality ...

6. painmanagementnursing.org painmanagementnursing.org/article/S1524-9042(24)00233-9/fulltext

The Feasibility of Utilizing Virtual Reality During Vascular ... Patients have reported that they feel safe using the equipment, and we have not seen any spread of infection. Overall, participants were highly ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9517958/

Use and efficacy of virtual, augmented, or mixed reality ... VR/AR/MR was associated with improved pain-related outcomes in 78% of the RCTs. Conclusion. While most studies showed effects immediately or up ...