Virtual Reality for Head and Neck Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Must not be taking: Antidepressants

Disqualifiers: Serious mental illness, substance abuse, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 10-11 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial tests how well a three-dimensional (3D) mindfulness virtual reality (VR) versus (vs) two-dimensional (2D) non-immersive interventions works in improving depression, anxiety, pain, and/or stress in patients with head and neck cancer (HNC) undergoing radiation or chemoradiation (C/RT), and their caregivers. HNC patients undergoing C/RT can experience higher levels of depression, anxiety, distress and pain that negatively impact their quality of life. VR allows for a realistic experience and works as an effective distraction tool from the state of pain or anxiety without use of drugs and with minimal associated risk to patients. VR has been shown to help reduce symptoms of depression, anxiety and pain in non-cancer patients, however there is limited evidence of how well VR use works in cancer patients, especially in patients undergoing C/RT for HNC. Caregivers of these patients also experience high levels of anxiety and distress. Using VR interventions may improve depression, anxiety, pain and/or stress in patients with HNC undergoing C/RT and their caregivers.

Research Team

Krupal B Patel

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

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.

Exclusion Criteria

I have been treated for head and neck cancer before.

Patients: Inability to complete the surveys

Patients: Serious mental illness

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Arm A (3D mindfulness VR headset) Experimental Treatment 4 Interventions

Participants receive 3D mindfulness VR headset consisting of 6 resilience skills training sessions over 30 minutes TIW for 6-7 weeks then weekly for 4 weeks. Participants also wear a Fitbit activity tracker to monitor heart rate, sleep and activity throughout the study.

Group II: Arm B (2D non-immersive VR headset) Active Control 4 Interventions

Participants receive 2D non-immersive VR headset consisting of 2 scenarios - walk in the nature and beach TIW for 6-7 weeks then weekly for 4 weeks. Participants also wear a Fitbit activity tracker to monitor heart rate, sleep and activity throughout the study.

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+