Virtual Reality Interventions for the Improvement of Depression, Anxiety and Pain in Patients Wit… (NCT06985784) | Clinical Trial Compass
RecruitingNot Applicable
Virtual Reality Interventions for the Improvement of Depression, Anxiety and Pain in Patients With Head and Neck Cancer and Caregivers
United States40 participantsStarted 2025-06-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recruitment rate (Feasibility)
Timeframe: Up to 11 weeks
2
Retention rate (Feasibility)
Timeframe: Up to 11 weeks
3
Adherence to three-dimensional (3D) mindfulness virtual reality (VR) intervention (Feasibility)
Timeframe: Up to 11 weeks
4
Completion of electronic patient reported outcomes (ePRO) (Feasibility)