Virtual Reality for Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Roswell Park Cancer Institute

Disqualifiers: Brain metastases, Uncontrolled illness, Pregnant, Incarcerated, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Length of hospital stay up to 6 months

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether virtual reality (VR) can help manage symptoms such as depression, fatigue, and anxiety in patients undergoing hematopoietic stem cell transplantation (HSCT), a treatment for certain types of cancer. Participants will either use a VR device for relaxing activities or receive standard care. The trial seeks patients who are hospitalized for HSCT, alert, and able to give consent. As an unphased trial, this study provides patients the chance to explore innovative symptom management techniques during their treatment journey.

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 coordinators or your doctor.

What prior data suggests that this virtual reality intervention is safe for patients undergoing hematopoietic stem cell transplantation?

Research has shown that virtual reality (VR) is generally safe for cancer patients. Studies have found that patients using VR during treatment often experience reduced anxiety and improved mood. Importantly, these studies report very few cases of cybersickness, which involves dizziness or nausea from VR use.

One study examined VR's impact on pain and emotional well-being in cancer patients. The results were promising, indicating that patients found VR helpful and acceptable.

Overall, current evidence suggests that VR is a well-tolerated option for managing symptoms in cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) for cancer patients because it offers a unique approach to enhancing patient well-being during treatment. Unlike traditional therapies that focus solely on medical procedures, VR provides an immersive experience that can help reduce stress and anxiety through relaxation applications like meditation, art, and nature scenes. This innovative method aims to improve the overall inpatient experience, potentially offering a calming escape from the hospital environment. By incorporating VR into cancer care, researchers hope to find out if these virtual experiences can significantly enhance patients' quality of life alongside their standard treatments.

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

Research has shown that virtual reality (VR) can reduce anxiety, pain, and fatigue in cancer patients. Various studies found VR more effective than other distraction methods in alleviating symptoms like anxiety, depression, and fatigue during cancer treatments. VR provides a sensory escape, influencing what patients see, hear, and feel, which helps improve mood and comfort. In this trial, one group of participants will use VR applications focused on relaxation, such as meditation, art, and nature, while receiving standard care for hematopoietic stem cell transplantation (HSCT). Although VR has not been widely tested in HSCT patients, positive results in similar cancer care settings suggest it could help manage symptoms during HSCT. ^{4 6 7 8 9}

Who Is on the Research Team?

Heather Huizinga

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

This trial is for patients undergoing hematopoietic stem cell transplantation (HSCT) who experience symptoms like depression, tiredness, anxiety, drowsiness, lack of appetite, and pain. The study aims to improve their quality of life and well-being during hospitalization.

Inclusion Criteria

I will be staying in the hospital for at least one week.

Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

I am 18 or older and scheduled for a stem cell transplant at Roswell Park.

Exclusion Criteria

I am on a treatment that could cause a severe immune reaction.

I have brain metastases.

Pregnant patients

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients use the VR device for relaxation applications or undergo standard care while inpatient for HSCT

Length of hospital stay up to 6 months

Daily VR sessions while inpatient

Follow-up

Participants are monitored for symptom management and supportive medication use after discharge

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality

Trial Overview

The trial compares the effectiveness of virtual reality (VR) therapy with standard care in managing symptoms for HSCT patients. VR targets auditory, visual, and touch senses to potentially alleviate depression, fatigue, anxiety, appetite issues, and pain.

How Is the Trial Designed?

Group I: Arm I (VR use) Experimental Treatment 3 Interventions

Patients use the VR device to participate in applications related to relaxation such as mediation, art and nature, for up to 15 minutes, daily, while inpatient for standard of care HSCT.

Group II: Arm II (Standard care) Active Control 2 Interventions

Patients undergo standard care for the HSCT.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Published Research Related to This Trial

Immersive virtual reality (IVR) significantly reduces anxiety, depression, and fatigue in adult cancer patients undergoing chemotherapy, based on a systematic review of 15 trials with 607 adults.

In pediatric cancer patients, IVR effectively lowers pain and anxiety, indicating its potential as a supportive therapy during chemotherapy for both adults and children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of randomized controlled trials on the effectiveness of immersive virtual reality in cancer patients receiving chemotherapy. Gautama, MSN., Huang, TW., Haryani, H.[2023]

The North Central Cancer Treatment Group developed a real-time toxicity reporting system to enhance the monitoring of severe side effects in NCI-sponsored clinical trials, aiming to improve patient safety.

This system has been effective in monitoring phase II and III trials, such as the N9741 study on advanced colorectal cancer, allowing for timely modifications to ongoing clinical trials based on reported adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early detection of toxicity and adjustment of ongoing clinical trials: the history and performance of the North Central Cancer Treatment Group's real-time toxicity monitoring program. Goldberg, RM., Sargent, DJ., Morton, RF., et al.[2016]

A survey of 125 cancer cooperative groups across 58 countries revealed that while most do not have formal policies for using real-world data (RWD), a significant majority have previously conducted studies utilizing RWD for both exploratory and confirmatory purposes.

Despite their experience with RWD, these groups primarily focus on traditional clinical trials, indicating a need for greater understanding and expertise in RWD methodologies, as well as a recognition of its potential benefits like lower costs and larger sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world data in oncology: a questionnaire-based analysis of the academic research landscape examining the policies and experiences of the cancer cooperative groups. Saesen, R., Lacombe, D., Huys, I.[2023]

The study evaluated the diagnostic accuracy of electronic medical records for various cancers in Japan, finding that while sensitivity was high (100% for lung, breast, colorectal, and prostate cancers), the positive predictive value (PPV) was generally low, indicating potential issues with the accuracy of cancer diagnoses in real-world data.

For adverse events (AEs), the definitions based solely on the International Classification of Diseases were found to have low PPV, suggesting that the current methods for coding AEs in oncology may need improvement to enhance diagnostic reliability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of algorithms to identify patients with a diagnosis of major cancers and cancer-related adverse events in an administrative database: a validation study in an acute care hospital in Japan. Fujiwara, T., Kanemitsu, T., Tajima, K., et al.[2022]

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]

Virtual reality (VR) technology in medicine allows for repeated practice of medical procedures and offers diverse experiences with virtual organs, enhancing both learning and evaluation of clinical skills.

In clinical oncology, VR can simulate surgeries, aid in cancer diagnosis, improve patient education, and even help manage the psychological stress of cancer patients, showcasing its potential in palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality for palliative medicine. Oyama, H.[2004]

Virtual reality (VR) significantly increased feelings of joy and happiness in pediatric oncology patients undergoing chemotherapy, with 29 participants aged 10-18 showing marked improvements in emotional states during VR sessions.

While VR effectively enhanced mood, it did not provide additional benefits over a mobile game in reducing anxiety or increasing patience, suggesting that while VR is beneficial, its effects may be similar to other forms of distraction during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Virtual Reality (VR) on Psychological and Physiological Variables in Children Receiving Chemotherapy: A Pilot Cross-Over Study. Erdős, S., Horváth, K.[2023]

A systematic review of 17 studies involving 799 cancer patients found that virtual reality (VR) significantly improved pain, anxiety, upper extremity function, and quality of life after intervention, indicating its efficacy in cancer rehabilitation.

VR not only alleviated physical and psychological symptoms but also showed positive effects on cognitive function, suggesting it can be a valuable addition to comprehensive cancer rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of virtual reality on physical, cognitive, and psychological outcomes in cancer rehabilitation: a systematic review and meta-analysis. Hao, J., Li, Y., Swanson, R., et al.[2023]

The modified Global Trigger Tool (GTT) detected significantly more adverse events (AEs) in oncology patients (0.90 AEs per patient) compared to the voluntary safety reporting (VSR) system (0.24 AEs per patient), highlighting the GTT's greater efficacy in identifying medication-related AEs.

Over half of the AEs identified by the GTT caused harm to patients, with a notable portion being preventable, indicating a critical need for improved detection methods in oncology to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of a Voluntary Safety Reporting System to a Global Trigger Tool for Identifying Adverse Events in an Oncology Population. Samal, L., Khasnabish, S., Foskett, C., et al.[2023]

In a randomized crossover trial involving 50 cancer patients undergoing chemotherapy, Virtual Reality (VR) significantly improved mood states compared to Guided Imagery (GI), indicating its potential as a beneficial intervention for emotional well-being during treatment.

The VR intervention also led to statistically significant improvements in biophysical parameters like blood pressure and heart rate, although it did not show effectiveness in reducing symptoms of nausea, pain, or feeling sick.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Virtual Reality Vs Guided Imagery on mood changes in cancer patients receiving chemotherapy treatment: A crossover trial. Ioannou, A., Paikousis, L., Papastavrou, E., et al.[2022]

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