Virtual Reality for Cervical Cancer Comfort During Brachytherapy
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Arkansas
Disqualifiers: Seizure disorder, Motion sickness, Migraine, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing whether using virtual reality (VR) to distract patients can make brachytherapy for cervical cancer more comfortable. The study will compare patient experiences with and without VR during treatment. The goal is to see if VR can reduce pain and anxiety, making the procedure more tolerable. Virtual reality (VR) has been explored as a non-pharmacological method to manage pain and anxiety in cancer patients, showing potential benefits in various medical contexts.
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 data supports the effectiveness of the treatment Oculus Quest 2 Virtual Reality Headset for cervical cancer comfort during brachytherapy?
Research shows that virtual reality (VR) can help reduce anxiety, depression, and pain in cancer patients, suggesting it might also help improve comfort during cervical cancer treatments like brachytherapy.
12345Is using the Oculus Quest 2 VR headset generally safe for humans?
Research on virtual reality (VR) headsets, including the Oculus Quest 2, shows they are generally safe for use in humans, with only mild side effects like headache, dizziness, nausea, and neck pain reported in some studies.
46789How does the virtual reality treatment for cervical cancer during brachytherapy differ from other treatments?
The virtual reality treatment is unique because it uses immersive technology to distract patients during brachytherapy, potentially reducing anxiety and pain without the need for sedatives like nitrous oxide. This approach is different from traditional methods that rely on medication for comfort.
310111213Eligibility Criteria
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.
+2 more
Trial Timeline
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
Participant Groups
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.
4Treatment groups
Experimental Treatment
Group I: Sequence Group DExperimental Treatment1 Intervention
VR distraction occurring visits 2 and 3 with normal SOC therapy at visits 3 and 4.
Group II: Sequence Group CExperimental Treatment1 Intervention
VR distraction occurring visits 3 and 4 with normal SOC therapy at visits 1 and 2.
Group III: Sequence Group BExperimental Treatment1 Intervention
VR distraction occurring visits 1 and 4 with normal SOC therapy at visits 2 and 3.
Group IV: Sequence Group AExperimental Treatment1 Intervention
VR distraction occurring visits 1 and 2 with normal SOC therapy at visits 3 and 4.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Arkansas for Medical SciencesLittle Rock, AR
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Who Is Running the Clinical Trial?
University of ArkansasLead Sponsor
References
Exploring the use of Immersive Virtual Reality to enhance Psychological Well-Being in Pediatric Oncology: A pilot randomized controlled trial. [2021]To investigate whether Immersive Virtual Reality (VR) has a greater positive influence on oncology patients' physical and emotional mood states when compared to an iPad attentional control condition. Our secondary objective was to understand what factors influenced VR effectiveness.
Meta-Analysis of the Efficacy of Virtual Reality-Based Interventions in Cancer-Related Symptom Management. [2020]Background. This meta-analysis summarizes the results from recent studies that examined the use of virtual reality (VR)-based interventions on health-related outcomes in patients with cancer, and quantitatively evaluates the efficacy of VR-based interventions. Findings of this meta-analysis can provide direction for future symptom management research. Methods. The search terms included a combination of "virtual reality" OR "virtual environment" OR "head-mounted display" with "oncology" OR "cancer." Three databases (Medline, PubMed, and CAJ Full-text Database), one search engine (Google Scholar), and the website of ResearchGate, covering the period from December 2013 to May 15, 2019, and including articles published in both English and Chinese, were searched. Data synthesis used the RevMan 5.3 to generate pooled estimates of effect size. Results. A total of 6 empirical studies met the eligibility criteria. VR-based interventions had statistically significant effects on reducing symptoms of anxiety, depression, pain, and cognitive function, whereas statistically significant benefit was observed for fatigue (Z = 2.76, P = .006). Conclusion. Most recent studies have primarily examined VR-based interventions for symptom management in the acute stages of cancer care. However, the management of late and long-term side effects is central to cancer survivorship care. There is burgeoning empirical support for further research to evaluate the efficacy of VR-based interventions in cancer rehabilitation.
Virtual reality-based simulation improves gynecologic brachytherapy proficiency, engagement, and trainee self-confidence. [2021]Intracavitary brachytherapy is critical in treatment of cervical cancer with the highest rates of local control and survival. Only about 50% of graduating residents express confidence to develop a brachytherapy practice with caseload as the greatest barrier. We hypothesize that virtual reality (VR)-based intracavitary brachytherapy simulation will improve resident confidence, engagement, and proficiency.
Effects of distraction using virtual reality glasses during lumbar punctures in adolescents with cancer. [2022]To determine the effects of virtual reality (VR) glasses on adolescents with cancer undergoing lumbar punctures (LPs).
Virtual reality: a distraction intervention for chemotherapy. [2018]To explore virtual reality (VR) as a distraction intervention to relieve symptom distress in adults receiving chemotherapy treatments for breast, colon, and lung cancer.
Virtual Reality-Based Education for Patients Undergoing Radiation Therapy. [2022]We built a virtual reality (VR) application that runs on a commercially available standalone VR headset that allows patients to view a virtual simulation of themselves receiving radiotherapy. The purpose of this study was to determine if this experience can improve patient understanding of radiotherapy and/or reduce patient anxiety. We created software that reads data from our clinical treatment planning system and renders the plan on a life-size "virtual linear accelerator." The patient's CT simulation data is converted into a 3D translucent virtual human shown lying on the treatment table while visible yellow radiation beams are delivered to the target volumes in the patient. We conducted a prospective study to determine if showing patients their radiotherapy plan in VR improves patient education and/or reduces anxiety about treatment. A total of 43 patients were enrolled. The most common plans were 3D breast tangents and intensity-modulated radiotherapy prostate plans. Patients were administered pre- and post-experience questionnaires. Thirty-two patients (74%) indicated that they "strongly agree" that the VR session gave them a better understanding of how radiotherapy will be used to treat their cancer. Of the 21 patients who expressed any anxiety about radiotherapy beforehand, 12 (57%) said that the VR session helped decrease their anxiety about undergoing radiotherapy. In our single-institution, single-arm prospective patient study, we found that the majority of patients reported that the personalized VR experience was educational and can reduce anxiety. VR technology has potential to be a powerful adjunctive educational tool for cancer patients about to undergo radiotherapy.
Effect of Virtual Reality Therapy in Reducing Pain and Anxiety for Cancer-Related Medical Procedures: A Systematic Narrative Review. [2021]Virtual reality (VR) has emerged as a novel form of nonpharmacological analgesia therapy. We wished to review the use of VR to treat pain and anxiety in cancer-related medical procedures and chemotherapy.
Effects of immersive virtual reality for managing anxiety, nausea and vomiting among paediatric cancer patients receiving their first chemotherapy: An exploratory randomised controlled trial. [2022]To assess the feasibility and acceptability of immersive virtual reality for managing anxiety, nausea and vomiting amongst paediatric patients with cancer receiving their first chemotherapy.
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. [2023]Purpose: Cancer patients experience distress and anxiety when undergoing imaging studies to monitor disease status, yet these symptoms are not always appropriately identified or well-managed. This interim analysis of a phase 2 clinical trial explored feasibility and acceptability of a virtual reality relaxation (VR) intervention for primary brain tumor (PBT) patients at the time of clinical evaluation. Methods: English speaking, adult PBT patients with previous reports of distress and upcoming neuroimaging were recruited between March of 2021 and March 2022. A brief VR session was done within 2 weeks prior to neuroimaging with patient-reported outcomes (PROs) collected before and immediately post-intervention. Self-directed VR use over the next 1 month was encouraged with additional PROs assessments at 1 and 4 weeks. Feasibility metrics included enrollment, eligibility, attrition, and device-related adverse effects with satisfaction measured with qualitative phone interviews. Results: 55 patients were approached via email, 40 (73%) responded and 20 (50%) enrolled (9 declines, 11 screen fails). 65% of participants were ≤ 50 years, 50% were male, 90% were White/non-Hispanic, 85% had good KPS (≥ 90), and most were on active treatment. All patients completed the VR intervention, PROs questionnaires, weekly check-ins, and qualitative interview. Most (90%) reported frequent VR use and high satisfaction and only 7 mild AEs were recorded (headache, dizziness, nausea, neck pain). Conclusion: This interim analysis confirmed feasibility and acceptability of a novel VR intervention to target psychological symptoms for PBT patients. Trial enrollment will continue to assess for intervention efficacy. Trial Registration: NCT04301089 registered on 3/9/2020.
The Use of 3D Printing Technology in Gynaecological Brachytherapy-A Narrative Review. [2023]Radiation therapy, including image-guided adaptive brachytherapy based on magnetic resonance imaging, is the standard of care in locally advanced cervical and vaginal cancer and part of the treatment in other primary and recurrent gynaecological tumours. Tumour control probability increases with dose and brachytherapy is the optimal technique to increase the dose to the target volume while maintaining dose constraints to organs at risk. The use of interstitial needles is now one of the quality indicators for cervical cancer brachytherapy and needles should optimally be used in ≥60% of patients. Commercially available applicators sometimes cannot be used because of anatomical barriers or do not allow adequate target volume coverage due to tumour size or topography. Over the last five to ten years, 3D printing has been increasingly used for manufacturing of customised applicators in brachytherapy, with gynaecological tumours being the most common indication. We present the rationale, techniques and current clinical evidence for the use of 3D-printed applicators in gynaecological brachytherapy.
Virtual reality distraction during uterovaginal brachytherapy applicators' removal: A pilot comparative study. [2021]Label="PURPOSE">To assess the relevance of virtual reality distraction (VR) during uterovaginal brachytherapy applicators' removal, as an alternative to nitrous oxide (N2O) conscious sedation, to decrease anxiety and pain perception.
EM-Navigated Catheter Placement for Gynecologic Brachytherapy: An Accuracy Study. [2021]Gynecologic malignancies, including cervical, endometrial, ovarian, vaginal and vulvar cancers, cause significant mortality in women worldwide. The standard care for many primary and recurrent gynecologic cancers consists of chemoradiation followed by brachytherapy. In high dose rate (HDR) brachytherapy, intracavitary applicators and/or interstitial needles are placed directly inside the cancerous tissue so as to provide catheters to deliver high doses of radiation. Although technology for the navigation of catheters and needles is well developed for procedures such as prostate biopsy, brain biopsy, and cardiac ablation, it is notably lacking for gynecologic HDR brachytherapy. Using a benchtop study that closely mimics the clinical interstitial gynecologic brachytherapy procedure, we developed a method for evaluating the accuracy of image-guided catheter placement. Future bedside translation of this technology offers the potential benefit of maximizing tumor coverage during catheter placement while avoiding damage to the adjacent organs, for example bladder, rectum and bowel. In the study, two independent experiments were performed on a phantom model to evaluate the targeting accuracy of an electromagnetic (EM) tracking system. The procedure was carried out using a laptop computer (2.1GHz Intel Core i7 computer, 8GB RAM, Windows 7 64-bit), an EM Aurora tracking system with a 1.3mm diameter 6 DOF sensor, and 6F (2 mm) brachytherapy catheters inserted through a Syed-Neblett applicator. The 3D Slicer and PLUS open source software were used to develop the system. The mean of the targeting error was less than 2.9mm, which is comparable to the targeting errors in commercial clinical navigation systems.
A new development in ultrasound-compatible gynecologic brachytherapy simulators. [2021]Gynecologic brachytherapy is an essential component in the curative treatment of cervical cancer. With the decline in brachytherapy utilization, gynecologic brachytherapy simulators are being used to provide a mechanism to enhance proficiency-based resident training. However, most models that have been used lack procedural fidelity as they are either repurposed from OB/GYN basic models or from physics phantoms. Therefore, we set out to develop a high-fidelity, ultrasound- and CT-compatible gynecologic brachytherapy training simulator.