Using virtual reality to help improve mental health and pain in head and neck cancer patients and their caregivers
Enhancing Patient Well-Being: Feasibility of Virtual Reality in Head and Neck Cancer Patients to Improve Depressive Symptomatology, Anxiety and Pain
NA · City of Hope Medical Center · NCT06985784
This study is testing if a special virtual reality program can help improve mental health and reduce pain for people with head and neck cancer and their caregivers during treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Duarte, California) |
| Trial ID | NCT06985784 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a three-dimensional (3D) mindfulness virtual reality (VR) intervention compared to a two-dimensional (2D) non-immersive VR intervention in reducing depression, anxiety, and pain in patients with head and neck cancer undergoing chemoradiation, as well as their caregivers. Participants will be assigned to either the 3D VR group, which includes resilience skills training sessions, or the 2D VR group, which features nature and beach scenarios. Both groups will use a Fitbit to monitor their health metrics throughout the study. The trial aims to assess the feasibility, acceptability, and preliminary efficacy of these interventions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are scheduled to undergo chemoradiation for head and neck cancer.
Not a fit: Patients who are not undergoing chemoradiation for head and neck cancer or those with severe cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the mental health and pain management of head and neck cancer patients and their caregivers.
How similar studies have performed: While virtual reality has shown promise in reducing symptoms in non-cancer patients, there is limited evidence regarding its effectiveness specifically in cancer patients, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Duarte, California
- City of Hope Medical Center — Duarte, California, United States (RECRUITING)
Study contacts
- Principal investigator: Krupal Patel — City of Hope Medical Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Head and Neck Carcinoma