Decreasing Chemotherapy Induced Distress Using Immersive Virtual Reality in Patients With Cancer
NCT ID: NCT06446115
Last Updated: 2025-11-06
Study Results
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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RECRUITING
NA
70 participants
INTERVENTIONAL
2024-11-05
2026-01-30
Brief Summary
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Participants will:
* Be randomly assigned to one of two available groups (virtual reality or standard of care)
* Participations will only be during one chemotherapy session.
* Those assigned to virtual reality:
* The research team will provide a virtual reality
* The research team will provide guidance on how the headset works and will be available to assist with any questions or concerns.
* Participants will also be able to choose different relaxing backgrounds depending on their preference. headset during the chemotherapy session for 15 to 30 minutes
* Those assigned to the standard of care:
* The research team will provide the participants with the opportunity to choose a preferred activity such as reading a book, watching television, etc.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Virtual reality
Participants will be asked to use a headset device during 15 to 30 minutes while receiving a chemotherapy infusion. Participants have the option to choose from different virtual reality setting depending on their preference (i.e., nature videos, meditations, interactive applications, among others).
Virtual Reality
Virtual Reality Headset applied to the participants during chemotherapy session. Participants select their preferred virtual reality experience (i.e., nature videos, meditations, interactive applications, etc). Virtual reality (VR) by definition, is a simulated experience consisting of an experiential environment created by hardware and software technology capable of provoking sensations of real experiences. It can be further divided into 1) immersive; 2) semi-immersive; and 3) non-immersive. Immersive VR employs head-mounted display (HMD) system technology to separate users from their surroundings and engage in real-time with a three-dimensional environment generated by a computer.
Questionnaires
Participants will be administered multiple pre and post intervention questionnaires including NCCN Distress thermometer, GAD-7 and CCVA.
Standard of care
Participants will be asked to choose any activity of your preference during the chemotherapy session (i.e., watching tv, reading a book, listening to music or a podcast, etc.)
Preferred activity
Participants will engage in a preferred activity such as reading, watching television, coloring, etc. during chemotherapy.
Questionnaires
Participants will be administered multiple pre and post intervention questionnaires including NCCN Distress thermometer, GAD-7 and CCVA.
Interventions
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Virtual Reality
Virtual Reality Headset applied to the participants during chemotherapy session. Participants select their preferred virtual reality experience (i.e., nature videos, meditations, interactive applications, etc). Virtual reality (VR) by definition, is a simulated experience consisting of an experiential environment created by hardware and software technology capable of provoking sensations of real experiences. It can be further divided into 1) immersive; 2) semi-immersive; and 3) non-immersive. Immersive VR employs head-mounted display (HMD) system technology to separate users from their surroundings and engage in real-time with a three-dimensional environment generated by a computer.
Preferred activity
Participants will engage in a preferred activity such as reading, watching television, coloring, etc. during chemotherapy.
Questionnaires
Participants will be administered multiple pre and post intervention questionnaires including NCCN Distress thermometer, GAD-7 and CCVA.
Eligibility Criteria
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Inclusion Criteria
* Biopsy proven diagnosis of Cancer (any stage or type).
* Must have a National Comprehensive Cancer Network Distress Thermometer Score ≥ 5 any time since diagnosis.
* Must have the ability to understand and the willingness to sign a written informed consent document
* Followed by a medical oncologist, radiation oncologist, and/or breast surgeon at Cleveland Clinic.
* Ability to read and write in English or Spanish.
Exclusion Criteria
* No prior history of Cancer.
* Prior medical history of severe motion sickness.
* Prior medical history of seizures
* Pregnancy.
* Unable or unwilling to participate in the immersive Virtual Reality study at the Maroone Cancer Center
18 Years
ALL
No
Sponsors
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Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Zeina Nahleh, MD FACP
Role: PRINCIPAL_INVESTIGATOR
Cleveland Clinic Florida, Maroone Cancer Center
Locations
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Cleveland Clinic Florida, Maroone Cancer Center
Weston, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Zeina Nahleh, MD, FACP
Role: primary
Other Identifiers
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CASE3124
Identifier Type: -
Identifier Source: org_study_id