City of Hope Medical Center
Duarte, California, 91010, United States
Location status: Recruiting
NCT Number: NCT06985784
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Duarte, California, 91010, United States
Location status: Recruiting
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-immersive interventions.
II. Preliminary efficacy in reduction in depressive symptoms, anxiety and pain.
OUTLINE: Participants are assigned to 1 of 2 arms.
ARM A: Participants receive 3D mindfulness VR headset consisting of 6 resilience skills training sessions over 30 minutes three times a week (TIW) for 6-7 weeks then weekly for 4 weeks. Participants also wear a Fitbit activity tracker to monitor heart rate, sleep and activity throughout the study.
ARM B: Participants receive 2D non-immersive VR headset consisting of 2 scenarios - walk in the nature and beach TIW for 6-7 weeks then weekly for 4 weeks. Participants also wear a Fitbit activity tracker to monitor heart rate, sleep and activity throughout the study.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ancillary studies
Wear a Fitbit
Ancillary studies
Receive 3D mindfulness VR headset
Other names: Virtual Reality Intervention, Virtual Technology
Time frame: Up to 11 weeks
Will be considered feasible if ≥ 50% of patients agree to participate. Will be assessed using summary statistics.
Time frame: Up to 11 weeks
Will be considered feasible if ≥ 70% of patients are retained. Will be assessed using summary statistics.
Time frame: Up to 11 weeks
Will be considered feasible if ≥ 50% of patients use the 3D mindfulness VR intervention. Will be assessed using summary statistics.
Time frame: Up to 11 weeks
Will be considered feasible if ≥ 70% ePRO assessments are completed. Will be assessed using summary statistics.
Time frame: Up to 11 weeks
Will be considered acceptable if ≥ 50% patients have greater than neutral satisfaction at the end of the study period. Will be assessed using summary statistics.
Time frame: Up to 30 days after treatment completion
Will be assessed by interviews to obtain feedback. Descriptive statistics to summarize satisfaction questionnaire.
City of Hope Medical Center
Other
Enhancing Patient Well-Being: Feasibility of Virtual Reality in Head and Neck Cancer Patients to Improve Depressive Symptomatology, Anxiety and Pain
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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