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

NCT ID: NCT06985784

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-25

Study Completion Date

2027-11-09

Brief Summary

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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

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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.

Conditions

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Head and Neck Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm A (3D mindfulness VR headset)

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.

Group Type EXPERIMENTAL

Interview

Intervention Type OTHER

Ancillary studies

Medical Device Usage and Evaluation

Intervention Type OTHER

Wear a Fitbit

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Virtual Technology Intervention

Intervention Type OTHER

Receive 3D mindfulness VR headset

Arm B (2D non-immersive VR headset)

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.

Group Type ACTIVE_COMPARATOR

Interview

Intervention Type OTHER

Ancillary studies

Medical Device Usage and Evaluation

Intervention Type OTHER

Wear a Fitbit

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Virtual Technology Intervention

Intervention Type OTHER

Receive 2D non-immersive VR headset

Interventions

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Interview

Ancillary studies

Intervention Type OTHER

Medical Device Usage and Evaluation

Wear a Fitbit

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Virtual Technology Intervention

Receive 3D mindfulness VR headset

Intervention Type OTHER

Virtual Technology Intervention

Receive 2D non-immersive VR headset

Intervention Type OTHER

Other Intervention Names

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Virtual Reality Intervention Virtual Technology Virtual Reality Intervention Virtual Technology

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Krupal Patel

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

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City of Hope Medical Center

Duarte, California, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Krupal Patel

Role: primary

Other Identifiers

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NCI-2025-03568

Identifier Type: REGISTRY

Identifier Source: secondary_id

24530

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24530

Identifier Type: -

Identifier Source: org_study_id