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.
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: 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
Parallel
Interview
Other interventionAncillary studies
Medical Device Usage and Evaluation
Other interventionWear a Fitbit
Questionnaire Administration
Other interventionAncillary studies
Virtual Technology Intervention
Other interventionReceive 3D mindfulness VR headset
Virtual Technology Intervention
Other interventionReceive 2D non-immersive VR headset
Recruitment rate (Feasibility)
Will be considered feasible if ≥ 50% of patients agree to participate. Will be assessed using summary statistics.
Retention rate (Feasibility)
Will be considered feasible if ≥ 70% of patients are retained. Will be assessed using summary statistics.
Adherence to three-dimensional (3D) mindfulness virtual reality (VR) intervention (Feasibility)
Will be considered feasible if ≥ 50% of patients use the 3D mindfulness VR intervention. Will be assessed using summary statistics.
Completion of electronic patient reported outcomes (ePRO) (Feasibility)
Will be considered feasible if ≥ 70% ePRO assessments are completed. Will be assessed using summary statistics.
Preferences for VR based interventions
Will be assessed by interviews to obtain feedback. Descriptive statistics to summarize satisfaction questionnaire.
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
