Status:
RECRUITING
Virtual Reality Interventions for the Improvement of Depression, Anxiety and Pain in Patients With Head and Neck Cancer and Caregivers
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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, ...
Detailed Description
PRIMARY OBJECTIVE: I. Feasibility and acceptability of 3D mindfulness VR- vs 2D in HNC patients undergoing C/RT. SECONDARY OBJECTIVES: I. Assess patient- and caregiver-preference for 3D VR and non-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 9 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06985784
Start Date
June 25 2025
End Date
November 9 2027
Last Update
November 7 2025
Active Locations (1)
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1
City of Hope Medical Center
Duarte, California, United States, 91010