Recruiting

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

ClinicalTrials.gov IDNCT06985784

PhaseNA

Enrollment40

SponsorCity of Hope Medical Center

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Head and Neck Carcinoma

About this study

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.

Interventions

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

Primary outcomes

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

Eligibility information

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 locations

City of Hope Medical Center, Duarte, California 91010 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.