NCT06985784 Virtual Reality Interventions for the Improvement of Depression, Anxiety and Pain in Patients With Head and Neck Cancer and Caregivers
| NCT ID | NCT06985784 |
| Status | Recruiting |
| Phase | — |
| Sponsor | City of Hope Medical Center |
| Condition | Head and Neck Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-06-25 |
| Primary Completion | 2027-11-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-06-25 with a primary completion date of 2027-11-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Krupal Patel
PRINCIPAL INVESTIGATOR
City of Hope Medical Center
Frequently Asked Questions
Who can join the NCT06985784 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06985784 currently recruiting?
Yes, NCT06985784 is actively recruiting participants. Visit ClinicalTrials.gov or contact City of Hope Medical Center to inquire about joining.
Where is the NCT06985784 trial being conducted?
This trial is being conducted at Duarte, United States.
Who is sponsoring the NCT06985784 clinical trial?
NCT06985784 is sponsored by City of Hope Medical Center. The principal investigator is Krupal Patel at City of Hope Medical Center. The trial plans to enroll 40 participants.