RecruitingNot ApplicableNCT06446115

Decreasing Chemotherapy Induced Distress Using Immersive Virtual Reality in Patients With Cancer


Sponsor

Case Comprehensive Cancer Center

Enrollment

70 participants

Start Date

Nov 5, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if the use of virtual reality during chemotherapy treatment helps participants achieve an improvement in distress, which may include unpleasant experience, anxiety, depression and/or pain. 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.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • Age ≥ 18 years.
  • 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 Criteria6

  • Age <18 years.
  • 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

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Interventions

DEVICEVirtual 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.

OTHERPreferred activity

Participants will engage in a preferred activity such as reading, watching television, coloring, etc. during chemotherapy.

OTHERQuestionnaires

Participants will be administered multiple pre and post intervention questionnaires including NCCN Distress thermometer, GAD-7 and CCVA.


Locations(1)

Cleveland Clinic Florida, Maroone Cancer Center

Weston, Florida, United States

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NCT06446115


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