Virtual Reality for Chemotherapy Distress in Cancer

Overseen By Zeina Nahleh, MD FACP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Severe motion sickness, Seizures, Pregnancy, others

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

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

70 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if the use of virtual reality during chemotherapy treatment helps participants achieve an improvement in distress, which may include unpleasant experience, anxiety, depression and/or pain. Participants will: * Be randomly assigned to one of two available groups (virtual reality or standard of care) * Participations will only be during one chemotherapy session. * Those assigned to virtual reality: * The research team will provide a virtual reality * The research team will provide guidance on how the headset works and will be available to assist with any questions or concerns. * Participants will also be able to choose different relaxing backgrounds depending on their preference. headset during the chemotherapy session for 15 to 30 minutes * Those assigned to the standard of care: * The research team will provide the participants with the opportunity to choose a preferred activity such as reading a book, watching television, etc.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using virtual reality during a chemotherapy session, so it's unlikely that your medications will be affected.

What data supports the effectiveness of the treatment Virtual Reality Therapy for reducing chemotherapy distress in cancer patients?

Research shows that virtual reality (VR) can help reduce symptoms like anxiety, depression, and pain in cancer patients undergoing chemotherapy. VR acts as a distraction, making the treatment experience less distressing. ^{1 2 3 4 5}

Is virtual reality therapy safe for use in humans?

Research on virtual reality therapy, including its use for managing pain, anxiety, and other symptoms in cancer patients, suggests it is generally safe for humans. Studies have explored its use in both adults and children undergoing chemotherapy, with no significant safety concerns reported. ^{4 6 7 8 9}

How does virtual reality treatment differ from other treatments for chemotherapy distress in cancer?

Virtual reality (VR) is unique because it serves as a distraction tool to alleviate anxiety, depression, and fatigue during chemotherapy, making it more effective than traditional methods like music therapy. Unlike medications, VR is a non-drug intervention that provides immersive and interactive experiences to improve mood and reduce psychological distress. ^{1 3 4 6 10}

Research Team

Zeina Nahleh, MD

Principal Investigator

Cleveland Clinic Florida, Maroone Cancer Center

Eligibility Criteria

This trial is for cancer patients undergoing chemotherapy who are interested in exploring whether virtual reality can reduce distress, anxiety, depression, or pain during treatment. Participants must be willing to use a VR headset or engage in standard activities like reading.

Inclusion Criteria

My cancer diagnosis was confirmed through a biopsy.

I can understand and am willing to sign the consent form.

Must have a National Comprehensive Cancer Network Distress Thermometer Score ≥ 5 any time since diagnosis

Exclusion Criteria

I am under 18 years old.

I cannot or do not want to join the Virtual Reality study.

I have a history of severe motion sickness.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo a single chemotherapy session with either virtual reality or standard of care activities

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in distress, pain, anxiety, and depression scores post-intervention

1 day

1 visit (in-person)

Treatment Details

Interventions

• Virtual Reality

Trial Overview The study tests if using immersive virtual reality during one chemotherapy session can lessen patient distress compared to those doing preferred activities such as reading or watching TV. Patients will be randomly placed into either the VR group or the standard care group.

Participant Groups

Group I: Virtual reality Experimental Treatment 2 Interventions

Participants will be asked to use a headset device during 15 to 30 minutes while receiving a chemotherapy infusion. Participants have the option to choose from different virtual reality setting depending on their preference (i.e., nature videos, meditations, interactive applications, among others).

Group II: Standard of care Active Control 2 Interventions

Participants will be asked to choose any activity of your preference during the chemotherapy session (i.e., watching tv, reading a book, listening to music or a podcast, etc.)

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Findings from Research

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) 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]

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]

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) 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 enhances emotional well-being in women with breast cancer by increasing positive emotions and reducing anxiety during physiotherapy sessions, regardless of the immersion method used.

Participatory VR was found to create a stronger sense of presence compared to contemplative VR, suggesting that the level of patient involvement in the virtual experience can impact emotional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contemplating or Acting? Which Immersive Modes Should Be Favored in Virtual Reality During Physiotherapy for Breast Cancer Rehabilitation. Buche, H., Michel, A., Piccoli, C., et al.[2022]

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]

The study involving 19 pediatric cancer patients showed that immersive virtual reality significantly reduced anxiety and acute nausea during their first chemotherapy sessions, indicating its potential effectiveness as a supportive intervention.

The high consent and low withdrawal rates suggest that immersive virtual reality is not only feasible but also well-accepted by patients, parents, and healthcare providers in a clinical setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of immersive virtual reality for managing anxiety, nausea and vomiting among paediatric cancer patients receiving their first chemotherapy: An exploratory randomised controlled trial. Lee Wong, C., Li, CK., Choi, KC., et al.[2022]

The study involving 11 children aged 10-17 showed that using virtual reality (VR) as a distraction during chemotherapy significantly reduced immediate symptom distress, indicating its potential effectiveness as a supportive intervention.

However, the VR intervention did not have a lasting effect on symptom distress after treatment, and it did not significantly influence anxiety levels during chemotherapy sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of virtual reality on symptom distress in children receiving chemotherapy. Schneider, SM., Workman, ML.[2009]

In a study involving 90 breast cancer patients, both virtual reality (VR) and music therapy (MT) were found to effectively reduce psychological distress during chemotherapy, improving mood and alleviating anxiety.

VR was shown to be more effective than MT in specifically reducing anxiety, depression, and fatigue, highlighting its potential as a powerful tool for enhancing treatment tolerance and quality of life in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality and music therapy as distraction interventions to alleviate anxiety and improve mood states in breast cancer patients during chemotherapy. Chirico, A., Maiorano, P., Indovina, P., et al.[2021]

References

1. 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]

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

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

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

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

4. 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]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Virtual reality for palliative medicine. [2004]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Contemplating or Acting? Which Immersive Modes Should Be Favored in Virtual Reality During Physiotherapy for Breast Cancer Rehabilitation. [2022]

7. 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]

8. Scotland pubmed.ncbi.nlm.nih.gov

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]

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

Effects of virtual reality on symptom distress in children receiving chemotherapy. [2009]

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

Virtual reality and music therapy as distraction interventions to alleviate anxiety and improve mood states in breast cancer patients during chemotherapy. [2021]