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

Overview

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.

Interventions

• Other Interview
  Ancillary studies
• Other Medical Device Usage and Evaluation
  Wear a Fitbit
• Other Questionnaire Administration
  Ancillary studies
• Other Virtual Technology Intervention
  Receive 3D mindfulness VR headset
• Other Virtual Technology Intervention
  Receive 2D non-immersive VR headset

Primary outcome measures

• Recruitment rate (Feasibility) [Time frame: Up to 11 weeks]
• Retention rate (Feasibility) [Time frame: Up to 11 weeks]
• Adherence to three-dimensional (3D) mindfulness virtual reality (VR) intervention (Feasibility) [Time frame: Up to 11 weeks]
• Completion of electronic patient reported outcomes (ePRO) (Feasibility) [Time frame: Up to 11 weeks]
• Acceptability of 3D mindfulness VR intervention [Time frame: Up to 11 weeks]

Secondary outcome measures (1)

• Preferences for VR based interventions [Time frame: Up to 30 days after treatment completion]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• City of Hope Medical Center — Duarte

Identifiers

NCT: NCT06985784 · 24530 · NCI-2025-03568 · 24530 · P30CA033572

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗