Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06446115
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-29
Brief Title:
Decreasing Chemotherapy Induced Distress Using Immersive Virtual Reality in Patients With Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Decreasing Chemotherapy Induced Distress Using Immersive Virtual Reality in Patients With Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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
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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None