Virtual Reality for Acute Lymphoblastic Leukemia
(VIRALL Trial)
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Children's National Research Institute
Disqualifiers: Relapsed, Refractory, Ultrasound guided, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?Over 90% of children and adolescents diagnosed with acute lymphoblastic leukemia (ALL) will survive long term. Part of the successful treatment that patients receive is the delivery of chemotherapy directly into their spinal fluid via a spinal tap. This takes place approximately 20 times over the course of treatment. Most children and adolescents receive general anesthesia during this procedure to manage pain and anxiety. It is now understood that general anesthesia contributes to impairments in brain functioning in the long term. Therefore, it is important to identify ways to manage pain and anxiety during these procedures that does not include general anesthesia. The investigators propose to test whether virtual reality (VR: a technology that provides immersive experiences utilizing content uploaded on a headset), used with local anesthesia and the option for an anti-anxiety medication will be an adequate replacement for general anesthesia for participants 7 years of age and over, with ALL in the maintenance phase of treatment.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, since the focus is on using virtual reality instead of general anesthesia, it seems unlikely that you would need to stop other medications.
What data supports the effectiveness of the treatment Virtual Reality Therapy for Acute Lymphoblastic Leukemia?
Research shows that virtual reality can help reduce pain and anxiety in children with cancer, including those receiving treatments like chemotherapy. It provides a fun and engaging distraction, making medical procedures less stressful and more comfortable for young patients.
12345Is Virtual Reality Therapy safe for humans?
There is no specific safety data available for Virtual Reality Therapy in the context of acute lymphoblastic leukemia, but general safety information for VR therapy in other conditions suggests it is generally safe for humans.
678910How is Virtual Reality Therapy different from other treatments for acute lymphoblastic leukemia?
Virtual Reality Therapy is unique because it uses immersive technology to potentially help manage symptoms and improve the quality of life for patients, rather than directly targeting the leukemia cells like traditional chemotherapy or stem cell transplantation.
1112131415Eligibility Criteria
This trial is for children and adolescents over 7 years old with acute lymphoblastic leukemia (ALL) who are in the maintenance phase of treatment. They must be scheduled to receive spinal taps as part of their therapy but cannot participate if they have conditions that make VR use unsafe or have had previous adverse reactions to local anesthesia or anti-anxiety medications.Inclusion Criteria
My initial diagnosis was either ALL or Lymphoma.
I am currently in the maintenance phase of my treatment.
Patient able to speak English
+3 more
Exclusion Criteria
My condition has returned or didn't respond to treatment.
Already does LPs without anesthesia
I have had an ultrasound-guided lumbar puncture before.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive intrathecal chemotherapy with pain and anxiety management using VR, local anesthesia, and optional anxiolytics during lumbar punctures
Approximately 20 procedures over the course of treatment
20 visits (in-person)
Follow-up
Participants are monitored for feasibility and acceptability of VR as an alternative to general anesthesia
1-3 months
Participant Groups
The study is testing whether using a Virtual Reality headset, along with local anesthesia and optional anti-anxiety medication, can effectively manage pain and anxiety during spinal taps, as an alternative to general anesthesia.
2Treatment groups
Experimental Treatment
Active Control
Group I: VR ArmExperimental Treatment1 Intervention
Pain and anxiety management in this arm will include: topical numbing cream 30 minutes prior to the scheduled procedure, option for a 0.05mg/kg (max 2 mg) oral/IV dose of lorazepam. VR headsets will be donned. After sterile cleaning of the lumbar spine area, lidocaine will be injected between L3-4 or L4-5 for local anesthetic. A 22-gauge needle of appropriate length (1.5, 2.5, 3.5 inch) will be used to access the intrathecal space. Cerebral spinal fluid will be collected for evaluation (standard procedure) and IT chemotherapy will be administered.
Group II: GA ArmActive Control1 Intervention
Pain and anxiety in this arm will be managed with general anesthesia, usually propofol, which is the current standard of care at Children's National Hospital.
Virtual Reality is already approved in United States for the following indications:
🇺🇸 Approved in United States as Virtual Reality Therapy for:
- Functional Dyspepsia
- Irritable Bowel Syndrome (IBS)
- Gastroparesis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Children's National HospitalWashington, United States
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Who Is Running the Clinical Trial?
Children's National Research InstituteLead Sponsor
Rally Foundation for Childhood Cancer ResearchCollaborator
Rally Foundation for Childhood Cancer ResearchCollaborator
References
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.
Immersive Virtual Reality to Distract From Pain in Children Treated With L-asparaginase by Intramuscular Injection. [2023]Background Treatment-related pain and discomfort are two of the most common manifestations in children with acute lymphoblastic leukemia (ALL). Patients with ALL are usually treated with L-asparaginase (L-ASP) by intramuscular injection. Children receiving L-ASP chemotherapy must bear adverse reactions such as pain caused by intramuscular injections. The use of virtual reality (VR) distraction technology could be a non-pharmacological intervention to bolster patients' comfort and decrease anxiety and procedure-related pain within hospital settings. Methodology The study explored the potential benefits of VR as a psychological intervention to induce positive emotions and reduce pain levels in participants receiving L-ASP injections. Participants in the study had the opportunity to select a nature theme of their choosing during their treatment session. The study provided a noninvasive solution that promoted relaxation to reduce anxiety by shifting an individual's mood positively during treatment. The objective was met by measuring participants' mood and pain levels before and after the VR experience and participant satisfaction with the use of the technology. This mixed-methods study of children aged six to 18 received L-ASP between April 2021 and March 2022, using a Numerical Rating Scale (NRS) with sheer numbers ranging from 0 (no pain) to 10 (extreme or most pain possible). Semi-structured interviews were conducted to collect new data and explore participants' thoughts and beliefs about a particular topic. A total of 14 patients participated. Descriptive statistics and content analysis are used to describe the data analyzed. VR is an enjoyable distraction intervention for managing treatment-related pain in ALL with intramuscular chemotherapy. Results Eight of 14 patients found a reduction in perceived pain after wearing VR. During the intervention implementation, the primary caregivers felt that the patient's pain perception was more positive when using the virtual reality device, and there was less resistance and less crying. Conclusions This study describes changes and experiences associated with pain and physical discomfort in children with ALL receiving intramuscular chemotherapy. This teaching model is applied to developing medical personnel, providing information about the disease and daily care, and educating the participants' family members. This study may expand the usage of VR applications so that more patients can benefit from them.
Feasibility, Acceptability, and Clinical Implementation of an Immersive Virtual Reality Intervention to Address Psychological Well-Being in Children and Adolescents With Cancer. [2021]Objective: Virtual reality (VR), a novel and highly immersive technology, offers promise in addressing potential psychological impacts of cancer treatments and hospitalization. The primary aim of this study was to examine multiple key user perspectives on the acceptability and feasibility of an Immersive VR therapeutic intervention for use with hospitalized patients with cancer. Secondary aims were to identify issues and opportunities related to the adoption and clinical implementation of VR in pediatric oncology settings. Method: The study was conducted at The Royal Children's Hospital (RCH), Melbourne, Australia. Thirty multidisciplinary oncology health care professionals participated in an initial test of VR intervention usability (Stage 1). Ninety oncology inpatients (7-19 years) and their parent caregivers participated in a pilot randomized controlled study to examine the effectiveness of an Immersive VR therapeutic intervention (Stage 2). This mixed methods study reports Stages 1 and 2 quantitative and qualitative data related to VR feasibility and acceptability. Results: Results indicate favorable perceptions from health care professionals with respect to ease of use and usefulness of VR, and had positive intentions to use it in the future. Parent caregivers reported high acceptability of VR for their hospitalized child. Patients reported high satisfaction of the VR intervention within minimal adverse effects. Barriers and facilitators to VR use with seriously ill children and specific recommendations for content development were elicited. Conclusion: This study shows that there are several potential clinical uses for Immersive VR intervention, beyond medical procedural distraction, to support psychological adjustment to hospitalization and patient quality of life.
Effectiveness of Virtual Reality in Anxiety and Pain Management in Children and Adolescents Receiving Cancer Treatment: A Systematic Review and Meta-analysis of Randomized Controlled Trials. [2023]The study aimed to investigate the effect of virtual reality interventions on relieving pain and anxiety in children and adolescents receiving cancer treatment. A search that involved Cochrane Library (comprising Cochrane Central Register of Controlled Trials (CENTRAL)), PubMed, ProQuest, MEDLINE, Web of Sciences, Science Direct, and Scopus electronic databases covering the records from January 1, 2000 up to May, 2023 was conducted to determine randomized controlled trials that could be included in our study. The results of the search were limited to "anxiety and pain, adolescents, children, virtual reality, cancer." Of the 160 articles that were reached during the search, seven were found eligible based on inclusion criteria. Hedges' g effect size was calculated for each article. Random effects model was used to test effect sizes and moderator variables. The registration number of this meta-analysis on PROSPERO is CRD42022304737. The outcomes were pain and anxiety. Compared with standard care, virtual reality had a medium and significant effect on anxiety (g = 0.60, 95% CI: [- 1.05 - 0.15]) and pain (g = - 0.667, 95% CI: [- 1.08- -0.24]). In addition, age has been identified as an important moderator in the use of virtual reality in pain management. This meta-analysis shows that virtual reality applications are effective interventions for reducing pain and anxiety in the field of pediatric oncology. However, it is necessary to carry out randomized controlled trials that have large samples for evidence-based virtual reality applications in pediatric oncology.
Use of virtual reality in the supportive care management of paediatric patients with cancer. [2021]Paediatric patients with cancer undergo multiple treatments and procedures that can be invasive and painful. Virtual reality technologies could support the management of paediatric cancer. This Review focuses on the physiological and psychological efficacy of virtual reality in supportive care management. Virtual reality has shown potential in reducing pain scores, pulse rates, and distress scores, but has no significant effect on other indicators, such as anxiety, fear, and depression. Several virtual reality characteristics might affect its effectiveness when used in the paediatric cancer setting. Virtual reality games with high fidelity (eg, fully-isolating head-mounted display, stereo sound, and controllers) components provide a higher level of immersion, presence, and narrative engagement, which could better manage pain. Personalising the virtual reality experience to the patient and procedure would also improve accessibility and comfort. Clinicians should work closely with virtual reality developers to ensure that the virtual reality applications used are appropriate for their patients.
Longitudinal use of patient reported outcomes in pediatric leukemia and lymphoma reveals clinically relevant symptomatic adverse events. [2022]Leukemia and lymphoma (LL) are the most common cancer diagnoses of childhood with high survival rates, but not without impact on the child's functioning and quality of life. This study aimed to use patient-reported data to describe the symptomatic adverse event (AE) experiences among children with LL diagnoses.
Impairment of health-related quality of life for children with acute lymphoblastic leukemia over the first year of therapy: A report from the DFCI ALL Consortium. [2023]Children treated for acute lymphoblastic leukemia (ALL) receive prolonged treatment, resulting in toxicities that affect health-related quality of life (HR-QoL). Longitudinal assessment of HR-QoL allows improved understanding of experiences with ALL.
[Experience in using hydrotherapy in children with acute lymphoblastic leukemia at a sanatorium]. [2007]34 children aged 10-15 years in long-term remission of acute lymphoblastic leukemia were on combined rehabilitation for concomitant diseases. Adjuvant balneotherapy promoted improvement in the heart rate and decreased asymmetry of circulation. No side effects were registered.
Advances of CD19-directed chimeric antigen receptor-modified T cells in refractory/relapsed acute lymphoblastic leukemia. [2023]Refractory/relapsed B-cell acute lymphoblastic leukemia remains to be a significant cause of cancer-associated morbidity and mortality for children and adults. Developing novel and effective molecular-targeted approaches is thus a major priority. Chimeric antigen receptor-modified T cell (CAR-T) therapy, as one of the most promising targeted immunotherapies, has drawn extensive attention and resulted in multiple applications. According to published studies, CD19-directed CAR-T cells (CD19 CAR-T) can reach a complete remission rate of 94% in both children and adults with refractory/relapsed ALL, much higher than that of chemotherapy. However, the encouraging outcomes are often associated with complications such as cytokine release syndrome (CRS), serious neurotoxicity, and on-target off-tumor effect, which seriously impeded further clinical application of CAR-T cells. Moreover, CAR-T therapy is typically associated with high relapse rate. This article briefly reviews the manufacture technologies, the conditioning regimens, the cell infusion doses, as well as the prevention and treatment strategies of complications for CAR-T cell therapy.
Childhood acute lymphocytic leukemia: progress and problems in treatment. [2018]Acute lymphocytic leukemia is the most common cancer of childhood. A series of total therapy studies begun in 1962 at St. Jude Children's Research Hospital in Memphis, Tennessee has had a dramatic impact on the survival of children with this disease. These studies have systematically examined various drug combinations and radiation therapy in an effort to cure acute lymphocytic leukemia. As a result, a once uniformly fatal condition is now curable in nearly one half of cases. In addition to improved control of the primary disease, refinements in drug treatment and in supportive care have diminished the frequency of severe infections, which may complicate aggressive therapy. Although the quality of life for the survivors so far appears generally good, treatment-induced toxic effects may impose subtle, though significant, handicaps in some cases. A combination of clinical and laboratory investigations begun in the mid-1970s is beginning to demonstrate a previously unknown heterogeneity among patients with acute lymphocytic leukemia. It is now possible to recognize a substantial minority of patients on the basis of these studies as being at "high risk" for treatment failure. For them, drastic modifications of present programs are being investigated in an attempt to improve their prognosis. For patients lacking high-risk features improvements are still needed, but changes in their treatment must be kept within the framework of what is presently successful and must address the hazard of long-term toxicity.
Unrelated donor allogeneic transplantation for adult acute lymphoblastic leukemia: a review. [2008]Acute lymphoblastic leukemia is highly sensitive to induction chemotherapy; however, long-term survival in adults has been less than 35%, primarily as a result of high relapse rate. Treatment for relapsed disease is even less successful. The optimal post-remission therapy in the first complete remission offers the best opportunity for leukemia-free survival. Allogeneic donor stem cell transplantation can offer a unique anti-leukemia effect and a potential for extended survival. We will discuss advances in unrelated donor (URD) stem cells transplantation, improvements in transplantation process and supportive care along with growing experience with umbilical cord blood (UCB) allografts.
Novel Therapies in the Treatment of Adult Acute Lymphoblastic Leukemia. [2022]Acute lymphoblastic leukemia (ALL) is a rare hematologic malignancy. Advances in multi-agent chemotherapy have resulted in dramatic improvements in the number of pediatric cases that result in a cure; however, until recently, treatment options for older adults or patients with relapsed and refractory disease were extremely limited. This review seeks to describe in greater detail a number of emerging novel treatment modalities recently approved for this cancer.
Novel Therapies in Acute Lymphoblastic Leukemia. [2022]Treatment options for patients with acute lymphoblastic leukemia (ALL) beyond standard chemotherapy have grown significantly in recent years. In this review, we highlight new targeted therapies in ALL, with an emphasis on immunotherapy.
Isolated ovarian relapse of pre-B acute lymphoblastic leukemia: a case report. [2009]Acute lymphoblastic leukemia is a malignant disease of the bone marrow in which early lymphoid precursors proliferate and replace normal marrow hematopoietic cells, resulting in a marked decrease in the production of normal blood cells.
Modern therapy of acute lymphoblastic leukemia. [2022]Although acute lymphoblastic leukemia is curable in one third of adult patients, results vary greatly on account of different clinical, immunologic, and cytogenetic/genetic characteristics. These data, along with the kinetics of response to early treatment, help establish the individual risk class with considerable accuracy, and support risk-specific treatments that should warrant optimal results with as little as possible nonrelapse mortality. Modern first-line therapy consists of standard- and high-dose chemotherapy (increasingly inspired to pediatric principles), hematopoietic stem-cell transplantation, and new targeted therapy, all integrated with the analysis of prognostic factors and the study of subclinical residual disease for key therapeutic decisions. These changes are improving long-term outcome, which in ongoing studies is expected close to 50% or greater.