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

Trial Summary

What is the purpose of this trial?

This clinical trial compares the use of virtual reality to standard care for improving symptom management in patients undergoing hematopoietic stem cell transplantation (HSCT). Significant symptoms experienced by hospitalized HSCT patients include, but are not limited to, depression, tiredness, anxiety, drowsiness, lack of appetite, pain, and overall decreased quality of life and well-being. Virtual reality (VR) as an intervention can provide these patients with a much-needed escape from their reality and has proven results in clinical settings as a distraction therapy. VR technology targets the patient's auditory, visual, and physical contact/touch senses, and has been evidenced to improve depression, fatigue, anxiety, appetite, and pain. Virtual reality may improve symptom management in patients undergoing HSCT.

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 data supports the effectiveness of the treatment Virtual Reality for cancer?

Research shows that virtual reality can help reduce anxiety, depression, pain, and fatigue in cancer patients, making it a promising tool for managing symptoms during cancer care. ^{1 2 3 4 5}

Is Virtual Reality generally safe for use in humans?

The research articles provided do not contain specific safety data on Virtual Reality treatments for cancer or other conditions. ^{6 7 8 9 10}

How is the treatment Virtual Reality unique for cancer patients?

Virtual Reality (VR) is unique for cancer patients because it provides an immersive environment that can help manage symptoms like anxiety, depression, and pain, and improve emotional well-being. Unlike traditional treatments, VR offers a non-invasive way to support patients psychologically and physiologically during their cancer journey. ^{1 2 3 11 12}

Research Team

Heather Huizinga

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Meta-Analysis of the Efficacy of Virtual Reality-Based Interventions in Cancer-Related Symptom Management. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Virtual reality for palliative medicine. [2004]

3. Germany pubmed.ncbi.nlm.nih.gov

Effects of virtual reality on physical, cognitive, and psychological outcomes in cancer rehabilitation: a systematic review and meta-analysis. [2023]

4. Scotland 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. [2023]

5. United States 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. [2023]

6. England 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. [2023]

7. England 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. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Awareness and compliance with pharmacovigilance requirements amongst UK oncology healthcare professionals. [2020]

9. United States 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. [2016]

10. United States 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. [2023]

11. Scotland pubmed.ncbi.nlm.nih.gov

Effectiveness of Virtual Reality Vs Guided Imagery on mood changes in cancer patients receiving chemotherapy treatment: A crossover trial. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Virtual Reality in Health System: Beyond Entertainment. A Mini-Review on the Efficacy of VR During Cancer Treatment. [2022]