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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT06985784
Status
Recruiting
Apply to this trial

Conditions

  • Head and Neck Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 25, 2025
Status verified
Nov 2025
Primary completion
Nov 9, 2027
Completion
Nov 9, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Arm A (3D mindfulness VR headset)
    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.
  • Active Comparator: Arm B (2D non-immersive VR headset)
    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.

Primary Outcome Measure

Recruitment rate (Feasibility) [ Time Frame: Up to 11 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Krupal Patel
[email protected]
626-256-4673
Krupal Patel (PRINCIPAL_INVESTIGATOR)

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By research site
City of Hope Medical Center· Duarte, CA

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