NCT06985784

Virtual Reality Interventions for the Improvement of Depression, Anxiety and Pain in Patients With Head and Neck Cancer and Caregivers

Enhancing Patient Well-Being: Feasibility of Virtual Reality in Head and Neck Cancer Patients to Improve Depressive Symptomatology, Anxiety and Pain

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. Feasibility and acceptability of 3D mindfulness VR- vs 2D in HNC patients undergoing C/RT. SECONDARY OBJECTIVES: I. Assess patient- and caregiver-preference for 3D VR and non-immersive interventions. II. Preliminary efficacy in reduction in depressive symptoms, anxiety and pain. OUTLINE: Participants are assigned to 1 of 2 arms. ARM A: Participants receive 3D mindfulness VR headset consisting of 6 resilience skills training sessions over 30 minutes three times a week (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. ARM B: 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.

Conditions

• Head and Neck Carcinoma

Interventions

Type	Name	Description
OTHER	Interview	Ancillary studies
OTHER	Medical Device Usage and Evaluation	Wear a Fitbit
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Virtual Technology Intervention	Receive 3D mindfulness VR headset
OTHER	Virtual Technology Intervention	Receive 2D non-immersive VR headset

Timeline

• Start date: 2025-06-25
• Primary completion: 2027-11-09
• Completion: 2027-11-09
• First posted: 2025-05-22
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States