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Trial Title:
Decreasing Chemotherapy Induced Distress Using Immersive Virtual Reality in Patients With Cancer
NCT ID:
NCT06446115
Condition:
Malignant Neoplasm
Cancer
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Virtual Reality
Chemotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This is a two-arm, randomized 1:1, pilot study.
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Virtual Reality
Description:
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.
Arm group label:
Virtual reality
Intervention type:
Other
Intervention name:
Preferred activity
Description:
Participants will engage in a preferred activity such as reading, watching television,
coloring, etc. during chemotherapy.
Arm group label:
Standard of care
Intervention type:
Other
Intervention name:
Questionnaires
Description:
Participants will be administered multiple pre and post intervention questionnaires
including NCCN Distress thermometer, GAD-7 and CCVA.
Arm group label:
Standard of care
Arm group label:
Virtual reality
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.
Detailed description:
In recent decades, new cancer cases have consistently risen. Participants diagnosed with
cancer commonly face psychological symptoms including distress, anxiety, and depression
in addition to physical symptoms (i.e., pain). Importantly, these symptoms might be
exacerbated during chemotherapy sessions. New innovative technological strategies have
been under development to control the symptoms and improve quality of life. Immersive
virtual reality (VR) is a simulated experience that enables participants to interact with
an artificial three-dimensional visual and auditory environment. VR could be an
innovative intervention to relieve psychological symptoms associated with chemotherapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cleveland Clinic Florida, Maroone Cancer Center
Address:
City:
Weston
Zip:
33331
Country:
United States
Status:
Recruiting
Contact:
Last name:
Zeina Nahleh, MD, FACP
Investigator:
Last name:
Zeina Nahleh, MD FACP
Email:
Principal Investigator
Start date:
November 5, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Case Comprehensive Cancer Center
Agency class:
Other
Source:
Case Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06446115
