Clinical trial NCT06985784: Virtual Reality Interventions for the Improvement of Depression, Anxiety and Pain in Patients With Head and Neck Cancer and Caregivers
Official title: Enhancing Patient Well-Being: Feasibility of Virtual Reality in Head and Neck Cancer Patients to Improve Depressive Symptomatology, Anxiety and Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Carcinoma
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2025-05-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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, 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.

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-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.

Eligibility 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

Primary outcomes:
measure: Recruitment rate (Feasibility)
timeFrame: Up to 11 weeks
measure: Retention rate (Feasibility)
timeFrame: Up to 11 weeks
measure: Adherence to three-dimensional (3D) mindfulness virtual reality (VR) intervention (Feasibility)
timeFrame: Up to 11 weeks
measure: Completion of electronic patient reported outcomes (ePRO) (Feasibility)
timeFrame: Up to 11 weeks
measure: Acceptability of 3D mindfulness VR intervention
timeFrame: Up to 11 weeks
Secondary outcomes:
measure: Preferences for VR based interventions
timeFrame: Up to 30 days after treatment completion
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Krupal B Patel
role: PRINCIPAL_INVESTIGATOR
References: