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NCT Number: NCT06985784

Virtual Reality Interventions for the Improvement of Depression, Anxiety and Pain in Patients With Head and Neck Cancer and Caregivers

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

Location status: Recruiting

Location contact

Krupal Patel

CONTACT

[email protected]

626-256-4673 ext. 89200

Krupal Patel

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interview

Other

Ancillary studies

Medical Device Usage and Evaluation

Other

Wear a Fitbit

Questionnaire Administration

Other

Ancillary studies

Virtual Technology Intervention

Other

Receive 3D mindfulness VR headset

Other names: Virtual Reality Intervention, Virtual Technology

Primary outcomes

  1. Recruitment rate (Feasibility)

    Time frame: Up to 11 weeks

    Will be considered feasible if ≥ 50% of patients agree to participate. Will be assessed using summary statistics.

  2. Retention rate (Feasibility)

    Time frame: Up to 11 weeks

    Will be considered feasible if ≥ 70% of patients are retained. Will be assessed using summary statistics.

  3. Adherence to three-dimensional (3D) mindfulness virtual reality (VR) intervention (Feasibility)

    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.

  4. Completion of electronic patient reported outcomes (ePRO) (Feasibility)

    Time frame: Up to 11 weeks

    Will be considered feasible if ≥ 70% ePRO assessments are completed. Will be assessed using summary statistics.

  5. Acceptability of 3D mindfulness VR intervention

    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.

Secondary outcomes

  1. Preferences for VR based interventions

    Time frame: Up to 30 days after treatment completion

    Will be assessed by interviews to obtain feedback. Descriptive statistics to summarize satisfaction questionnaire.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Enhancing Patient Well-Being: Feasibility of Virtual Reality in Head and Neck Cancer Patients to Improve Depressive Symptomatology, Anxiety and Pain

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 22, 2025
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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