Recruiting

3D VR vs. 2D Non-immersive

Sponsor:

City of Hope Medical Center

Code:

NCT06985784

Conditions

Head and Neck Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Interview

Medical Device Usage and Evaluation

Questionnaire Administration

Virtual Technology Intervention

Virtual Technology Intervention

Study Details

Brief 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.

Conditions

Head and Neck Carcinoma

Study ID

NCT06985784

Start date

Jun 25, 2025

Status verified date

Nov, 2025

Completion date

Nov 9, 2027

Anticipated

Primary completion date

Nov 9, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • PATIENTS: Documented informed consent of the participant and/or legally authorized representative

  • Assent, when appropriate, will be obtained per institutional guidelines
  • PATIENTS: ≥ 18 years
  • PATIENTS: Self-reported normal or corrected to normal vision and hearing
  • PATIENTS: Ambulatory (permitted to use walking aids such as cane or crutch)
  • PATIENTS: Ability to read and understand English for questionnaires
  • PATIENTS: Scheduled to undergo C/RT for their HNC
  • CAREGIVERS: Documented informed consent of the participant and/or legally authorized representative

  • Assent, when appropriate, will be obtained per institutional guidelines
  • CAREGIVERS: ≥ 18 years
  • CAREGIVERS: Self-reported normal or corrected to normal vision and hearing
  • CAREGIVERS: Ability to read and understand English for questionnaires
  • CAREGIVERS: A care giver identified by the patient and defined as a person who knows the patient well and is involved in the patient's medical care

Exclusion Criteria:

  • PATIENTS: An employee who is under the direct/ indirect supervision of the principal investigator (PI)/ a co-investigator/ the study manager
  • PATIENTS: A direct study team member
  • PATIENTS: Inability to complete the surveys
  • PATIENTS: Serious mental illness
  • PATIENTS: Previous head and neck cancer treatment
  • PATIENTS: History of any psychiatric disease treatment with anti-depressants, substance abuse, post-traumatic stress disorder (PTSD), chronic pain (> 3 months)
  • PATIENTS: Cancer in or around the eyes or ears; visual, hearing or cognitive impairment
  • CAREGIVERS: An employee who is under the direct/ indirect supervision of the PI/ a co-investigator/ the study manager
  • CAREGIVERS: A direct study team member
  • CAREGIVERS: Inability to complete the surveys
  • CAREGIVERS: Serious mental illness
  • CAREGIVERS: History of any psychiatric disease treatment with anti-depressants, substance abuse, PTSD

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Interview

Ancillary studies

Medical Device Usage and Evaluation

Wear a Fitbit

Questionnaire Administration

Ancillary studies

Virtual Technology Intervention

Receive 3D mindfulness VR headset

Virtual Technology Intervention

Receive 2D non-immersive VR headset

Primary outcome measure

  • Recruitment rate (Feasibility) [ Time Frame: Up to 11 weeks ]
  • Retention rate (Feasibility) [ Time Frame: Up to 11 weeks ]
  • Adherence to three-dimensional (3D) mindfulness virtual reality (VR) intervention (Feasibility) [ Time Frame: Up to 11 weeks ]
  • Completion of electronic patient reported outcomes (ePRO) (Feasibility) [ Time Frame: Up to 11 weeks ]
  • Acceptability of 3D mindfulness VR intervention [ Time Frame: Up to 11 weeks ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Krupal Patel

626-256-4673kruppatel@coh.org

Principal Investigator:

Krupal Patel

More Information

Sponsor

City of Hope Medical Center

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2025-11-10.