40 Participants Needed

Virtual Reality for Head and Neck Cancer

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: City of Hope Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how virtual reality (VR) can reduce depression, anxiety, pain, and stress in people with head and neck cancer undergoing treatments like radiation or chemoradiation. It compares a 3D immersive VR experience, which includes mindfulness training, to a simpler 2D experience to determine which is more effective. The trial may also benefit caregivers of these patients, who often face similar stress and anxiety. People with head and neck cancer starting radiation or chemoradiation, who can see and hear normally, and can walk (even with aids like a cane), might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative ways to improve quality of life during treatment.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you have a history of psychiatric disease treated with antidepressants, you may not be eligible to participate.

What prior data suggests that virtual reality interventions are safe for head and neck cancer patients?

Research has shown that virtual reality (VR) tools, such as the 3D mindfulness VR headset, are generally easy to use. Studies have found that VR can reduce symptoms of depression, anxiety, and pain in individuals without cancer. Although less research exists on cancer patients, the technology is considered safe.

In a study on VR for mindfulness in chronic pain management, participants reported no major side effects. The immersive VR experience can distract users, relieving pain and stress without medication.

The 2D non-immersive VR headset is also expected to be safe. While less immersive, it still offers a calming experience with scenes like walking in nature or visiting a beach.

Both VR types focus on mindfulness and relaxation, reducing the chance of side effects. VR has shown promise in improving mental well-being, making it a low-risk option for managing symptoms in head and neck cancer patients and their caregivers.12345

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) interventions for head and neck cancer because they offer a unique, non-invasive way to support patients' mental health and well-being during treatment. Unlike standard care options like chemotherapy, radiation, or surgery, these VR experiences focus on building resilience and reducing stress. The 3D mindfulness VR headset provides immersive resilience skills training, helping patients develop coping strategies through engaging virtual environments. Meanwhile, the 2D non-immersive VR headset allows patients to relax with calming scenarios like walking through nature or enjoying a beach scene. Both approaches aim to improve mental health and potentially enhance recovery while being monitored by Fitbits for additional health insights.

What evidence suggests that virtual reality interventions could be effective for improving depression, anxiety, pain, and stress in head and neck cancer patients?

Research has shown that virtual reality (VR) can reduce symptoms like anxiety, depression, and pain in people with various health issues. In this trial, participants will receive different VR interventions. Arm A will use a 3D mindfulness VR headset, which places users in a peaceful, lifelike setting and has proven effective in managing these symptoms. Arm B will use a 2D non-immersive VR headset. While strong evidence supports VR's benefits for people without cancer, research on its effectiveness for cancer patients, particularly those treated for head and neck cancer, is still developing. Early results suggest that VR might help reduce depression, anxiety, and pain in these patients by distracting them from their symptoms. For caregivers, who also experience high stress, VR might offer similar relief by lowering anxiety and distress.12467

Who Is on the Research Team?

KP

Krupal Patel

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for patients with head and neck cancer undergoing radiation or chemoradiation, as well as their caregivers. It aims to see if using virtual reality can help reduce depression, anxiety, pain, or stress during treatment.

Inclusion Criteria

Caregivers: Ability to read and understand English for questionnaires
Patients: Documented informed consent of the participant and/or legally authorized representative. Assent, when appropriate, will be obtained per institutional guidelines
I can walk on my own or with the help of a cane or crutch.
See 6 more

Exclusion Criteria

I have been treated for head and neck cancer before.
Patients: Inability to complete the surveys
Patients: Serious mental illness
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 3D mindfulness VR or 2D non-immersive VR interventions, with sessions three times a week for 6-7 weeks, then weekly for 4 weeks. Participants also wear a Fitbit activity tracker.

10-11 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of preferences for VR interventions.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Virtual Reality Interventions
Trial Overview The study compares the effects of a three-dimensional mindfulness VR intervention against a two-dimensional non-immersive experience on improving mental health and pain in both patients and caregivers.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (3D mindfulness VR headset)Experimental Treatment4 Interventions
Group II: Arm B (2D non-immersive VR headset)Active Control4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials
614
Recruited
1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

Study Details | NCT06985784 | Virtual Reality Interventions ...This clinical trial tests how well a three-dimensional (3D) mindfulness virtual reality (VR) versus (vs) two-dimensional (2D) non-immersive interventions ...
Virtual reality–guided mindfulness for chronic pain in ...The aim of this mixed methods study is to evaluate the feasibility of a VR-guided mindfulness (VRGM) intervention offered to adult cancer survivors with ...
Review Article Effectiveness of Virtual Reality in Symptom ...This study aimed to assess the effects of VR-based interventions on anxiety, pain, depression, fear, distress, and quality of life in cancer patients.
Virtual Reality Interventions for the Improvement of ...This clinical trial tests how well a three-dimensional (3D) mindfulness virtual reality (VR) versus (vs) two-dimensional (2D) non-immersive ...
Virtual Reality for Head and Neck CancerThis clinical trial tests how well a three-dimensional (3D) mindfulness virtual reality (VR) versus (vs) two-dimensional (2D) non-immersive interventions ...
A Systematic Review and Meta-AnalysisThis study aimed to assess the effects of VR-based interventions on anxiety, pain, depression, fear, distress, and quality of life in cancer patients.
Virtual Reality in Oncology for Patient-centered CareIn addition to the well-researched physical side effects, such as hair loss, nausea, fatigue and infertility, it is primarily mental stress that ...
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