Virtual Reality Therapy for Cancer-Related Symptoms

Recruiting at 1 trial location

Overseen By Katia Matychak, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Severe psychiatric, Chronic pain, Hospice, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

30 Participants Needed

Trial Summary

What is the purpose of this trial?

We propose an innovative approach to symptom management in cancer patients following cancer treatments, utilizing a Multimodal Integrative Therapy (MIT) delivered via Virtual Reality (VR) program, authorized by the US Food and Drug Administration for in-home use. Our primary goal is to generate pilot data on the effects of MIT-VR program on pain, fatigue, sleep, depression, and anxiety in participants suffering from chronic cancer symptoms following cancer treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it allows participants who are currently undergoing endocrine or immunotherapy treatments.

What data supports the effectiveness of the treatment Virtual Reality Therapy for cancer-related symptoms?

Research shows that virtual reality therapy can significantly reduce symptoms like anxiety, depression, and pain in cancer patients. It has also been effective in managing pain and improving the range of motion in patients with burn injuries, suggesting its potential benefits for other conditions as well. ^{1 2 3 4 5}

How is Virtual Reality Therapy different from other treatments for cancer-related symptoms?

Virtual Reality Therapy is unique because it uses immersive technology to create a virtual environment that helps distract patients from pain and anxiety, offering a non-drug approach to symptom management. Unlike traditional treatments, it provides an engaging experience that can improve mood and reduce discomfort during cancer care. ^{1 3 6 7 8}

Eligibility Criteria

This trial is for cancer patients dealing with chronic pain, fatigue, sleep issues, or anxiety after their treatments. Participants should be comfortable using a Virtual Reality (VR) program at home and have symptoms that persist following cancer therapy.

Inclusion Criteria

It's been over 3 months since my last cancer treatment.

I experience pain, anxiety, sleep issues, fatigue, or neuropathy due to my cancer or its treatment.

I can speak and write in English.

Exclusion Criteria

Any personal (or family first degree) history of mania, schizophrenia, or other psychoses

I am currently receiving only hospice or palliative care.

Color-blindness

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Enrollment

Participants complete baseline surveys and receive instructions about the intervention

1 day

1 visit (in-person)

Intervention

Participants engage in either virtual reality or audio interventions at home for five weeks

10 weeks

5 sessions per week (at home), check-in phone calls as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Virtual Reality Therapy

Trial Overview The study tests a Multimodal Integrative Therapy (MIT) delivered through VR called Relievrx, designed to manage symptoms like pain and anxiety in post-treatment cancer patients. The effectiveness of this FDA-authorized home-use program will be evaluated.

Participant Groups

Group I: Virtual reality arm Experimental Treatment 1 Intervention

In the virtual reality intervention, participants will complete the scheduled educational module five times in the week of the intervention. This VR is assisting users in using immersive reality to reduce pain, learning cognitive and behavior self-coping skills and retraining the pain pathways. There are several sessions, which will be delivered using an all-in-one head-mounted display. Each session varies in duration approximately from 3 to 15 minutes.

Group II: Audio Mp4 arm Placebo Group 1 Intervention

In the audio intervention, participants will complete the scheduled module 5 times a week of the intervention. The content is similar to that of the VR, which will be delivered by the audio player. Each session varies in duration approximately from 3 to 15 minutes.

Virtual Reality Therapy is already approved in United States for the following indications:

Approved in United States as Virtual Reality Therapy for:

• Pain management for vaso-occlusive crisis in sickle cell disease

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

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]

The study demonstrated that a 30-minute virtual reality session in an underwater environment significantly reduced pain by 59% and improved relaxation, tension, stress, anxiety, and mood in 20 patients with advanced colorectal cancer, indicating its potential as a non-pharmacological pain management tool.

All participants completed the VR session without significant side effects, showing high satisfaction (83%), which supports the feasibility and safety of using virtual reality for pain relief in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality for improving pain and pain-related symptoms in patients with advanced stage colorectal cancer: A pilot trial to test feasibility and acceptability. Kelleher, SA., Fisher, HM., Winger, JG., et al.[2022]

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]

Virtual reality (VR) interventions significantly reduced anxiety levels in breast cancer patients, with a strong effect size, and improved the range of motion in upper limbs, indicating potential benefits for rehabilitation.

While VR showed positive effects on anxiety and upper limb mobility, it did not significantly reduce fatigue, and the overall quality of evidence is low, suggesting that more robust clinical studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of virtual reality-based interventions for patients with breast cancer symptom and rehabilitation management: a systematic review and meta-analysis. Zhang, H., Xu, H., Zhang, ZX., et al.[2022]

In a study of 39 adults with burn injuries, immersive virtual reality (VR) significantly reduced pain scores during physical therapy sessions, with reductions of 27% in worst pain, 37% in time spent thinking about pain, and 31% in pain unpleasantness compared to standard therapy without VR.

The use of VR did not negatively impact the range of motion (ROM) during therapy, and 97% of patients reported only zero to mild nausea, indicating that VR is a safe and effective nonpharmacologic option for pain management in postburn rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of virtual reality on pain and range of motion in adults with burn injuries. Carrougher, GJ., Hoffman, HG., Nakamura, D., et al.[2021]

Virtual reality (VR) shows promising potential in reducing anxiety for patients with primary brain tumors and other solid tumors, although results for pain, distress, and mood are mixed.

Participants reported high satisfaction with VR interventions and very few adverse side effects, indicating that VR could be a safe and innovative approach for symptom management, but more rigorous clinical trials are needed to confirm its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of virtual reality for symptom management in solid-tumor patients with implications for primary brain tumor research: a systematic review. Leggiero, NM., Armstrong, TS., Gilbert, MR., et al.[2022]

A study involving 14 advanced cancer patients using immersive virtual reality (VR) at home over 4 days showed significant short-term improvements in symptoms like pain, anxiety, and depression immediately after VR sessions, despite no significant changes in overall scores from day one to day four.

The use of VR as a complementary therapy suggests potential benefits for managing psychological and physical symptoms in cancer patients, indicating it could be a valuable tool in palliative care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality in Home Palliative Care: Brief Report on the Effect on Cancer-Related Symptomatology. Moscato, S., Sichi, V., Giannelli, A., 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]

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. England pubmed.ncbi.nlm.nih.gov

Virtual reality for improving pain and pain-related symptoms in patients with advanced stage colorectal cancer: A pilot trial to test feasibility and acceptability. [2022]

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

Effect of Virtual Reality Therapy in Reducing Pain and Anxiety for Cancer-Related Medical Procedures: A Systematic Narrative Review. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Efficacy of virtual reality-based interventions for patients with breast cancer symptom and rehabilitation management: a systematic review and meta-analysis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The effect of virtual reality on pain and range of motion in adults with burn injuries. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Use of virtual reality for symptom management in solid-tumor patients with implications for primary brain tumor research: a systematic review. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual Reality in Home Palliative Care: Brief Report on the Effect on Cancer-Related Symptomatology. [2021]

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

Virtual reality: a distraction intervention for chemotherapy. [2018]