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

NCT06985784 | Recruiting DMC

• 3 other identifiers: 24530NCI-2025-03568P30CA033572
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Carcinoma

Outcome Measures

Primary Outcomes (5)

• Recruitment rate (Feasibility)

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

  Up to 11 weeks

• Retention rate (Feasibility)

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

  Up to 11 weeks

• 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.

  Up to 11 weeks

• Completion of electronic patient reported outcomes (ePRO) (Feasibility)

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

  Up to 11 weeks

• Acceptability of 3D mindfulness VR intervention

  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.

  Up to 11 weeks

Secondary Outcomes (1)

• Preferences for VR based interventions

  Up to 30 days after treatment completion

Study Arms (2)

Arm A (3D mindfulness VR headset)

EXPERIMENTAL

Participants receive 3D mindfulness VR headset consisting of 6 resilience skills training sessions over 30 minutes 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.

Other: Interview; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration; Other: Virtual Technology Intervention

Arm B (2D non-immersive VR headset)

ACTIVE COMPARATOR

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.

Other: Interview; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration; Other: Virtual Technology Intervention

Interventions

Interview OTHER

Ancillary studies

Arm A (3D mindfulness VR headset); Arm B (2D non-immersive VR headset)

Medical Device Usage and Evaluation OTHER

Wear a Fitbit

Arm A (3D mindfulness VR headset); Arm B (2D non-immersive VR headset)

Questionnaire Administration OTHER

Ancillary studies

Arm A (3D mindfulness VR headset); Arm B (2D non-immersive VR headset)

Virtual Technology Intervention OTHER

Receive 3D mindfulness VR headset

Also known as: Virtual Reality Intervention, Virtual Technology

Arm A (3D mindfulness VR headset)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Krupal Patel

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 22, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): November 9, 2027
• Study Completion (Estimated): November 9, 2027
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)