Head and Neck CarcinomaNCT06985784
Virtual Reality Interventions for the Improvement of Depression, Anxiety and Pain in Patients With Head and Neck Cancer and Caregivers
A study testing Interview, Medical Device Usage and Evaluation and Questionnaire Administration in people with Head and Neck Carcinoma, run by City of Hope Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Carcinoma
- What is being tested?
- Interview, Medical Device Usage and Evaluation and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2025to 9 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Krupal Patel, 626-256-4673 ext. 89200, kruppatel@coh.org
Krupal Patel
About this study
Official title: Enhancing Patient Well-Being: Feasibility of Virtual Reality in Head and Neck Cancer Patients to Improve Depressive Symptomatology, Anxiety and Pain
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.
Read the detailed description
PRIMARY OBJECTIVE:
- Feasibility and acceptability of 3D mindfulness VR- vs 2D in HNC patients undergoing C/RT.
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Head and Neck Carcinoma
- Being tested
- Interview, Medical Device Usage and Evaluation, Questionnaire Administration, Virtual Technology Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Ancillary studies
Medical Device Usage and EvaluationOther
Wear a Fitbit
Questionnaire AdministrationOther
Ancillary studies
Virtual Technology InterventionOther
Also called Virtual Reality Intervention, Virtual Technology
Receive 3D mindfulness VR headset
Virtual Technology InterventionOther
Also called Virtual Reality Intervention, Virtual Technology
Receive 2D non-immersive VR headset
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Interview; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration; Other: Virtual Technology Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate (Feasibility)
Will be considered feasible if ≥ 50% of patients agree to participate. Will be assessed using summary statistics.
Measured: Up to 11 weeks
Retention rate (Feasibility)
Will be considered feasible if ≥ 70% of patients are retained. Will be assessed using summary statistics.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 11 weeks
Secondary outcomes (1)
Preferences for VR based interventions
Will be assessed by interviews to obtain feedback. Descriptive statistics to summarize satisfaction questionnaire.
Measured: Up to 30 days after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start25 Jun 2025
- Primary completion9 Nov 2027 (estimated)
- Study completion9 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CarcinomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Krupal Patel, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985784
- Sponsor's protocol ID
- 24530
- Other IDs
- NCI-2025-03568, 24530, P30CA033572
- Status last verified
- Nov 2025
- First submitted
- 15 May 2025
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Patient Well-Being: Feasibility of Virtual Reality in Head and Neck Cancer Patients to Improve Depressive Symptomatology, Anxiety and Pain
- ClinicalTrials.gov ID
- NCT06985784
- Acronym / sponsor ID
- 24530
- Conditions
- Head and Neck Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 9 Nov 2027 (estimated)
- Study completion
- 9 Nov 2027 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Feasibility and acceptability of 3D mindfulness VR- vs 2D in HNC patients undergoing C/RT.
SECONDARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (3D mindfulness VR headset) | Experimental | Other: Interview, Other: Medical Device Usage and Evaluation, Other: Questionnaire Administration, Other: Virtual Technology InterventionParticipants 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. |
| Arm B (2D non-immersive VR headset) | Active comparator | Other: Interview, Other: Medical Device Usage and Evaluation, Other: Questionnaire Administration, Other: Virtual Technology InterventionParticipants 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- PATIENTS: Documented informed consent of the participant and/or legally authorized representative
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewAncillary studies | Other | Arm A (3D mindfulness VR headset), Arm B (2D non-immersive VR headset) |
| Medical Device Usage and EvaluationWear a Fitbit | Other | Arm A (3D mindfulness VR headset), Arm B (2D non-immersive VR headset) |
| Questionnaire AdministrationAncillary studies | Other | Arm A (3D mindfulness VR headset), Arm B (2D non-immersive VR headset) |
| Virtual Technology InterventionAlso: Virtual Reality Intervention, Virtual TechnologyReceive 3D mindfulness VR headset | Other | Arm A (3D mindfulness VR headset) |
| Virtual Technology InterventionAlso: Virtual Reality Intervention, Virtual TechnologyReceive 2D non-immersive VR headset | Other | Arm B (2D non-immersive VR headset) |
Primary outcome
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.
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.
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.
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.
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.
1 secondary outcome
Preferences for VR based interventions
Time frame: Up to 30 days after treatment completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
Related trials for Head and Neck Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Krupal Patel principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interview, Medical Device Usage and Evaluation and Questionnaire Administration in people with Head and Neck Carcinoma, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (Feasibility) (time frame: Up to 11 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.