Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06318338
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-03-13
Brief Title:
Virtual Reality to Promote Relaxation Prior to Simulation
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Abramson Cancer Center at Penn Medicine
Study Overview
Official Title:
Virtual Reality to Promote Mindfulness and Relaxation Prior to Radiation Simulation A Prospective Pilot Feasibility Study
Status:
RECRUITING
Status Verified Date:
2024-05
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 purpose of this study is to assess the feasibility of a pre-simulation virtual reality VR platform designed to promote relaxation for cancer patients planned for radiation therapy RT
Detailed Description:
The purpose of this prospective feasibility study is to assess the implementation of a VR-based intervention in patients who are pending initiation of RT The investigators hypothesize that this intervention will be safe and feasible If 75 of enrolled patients complete the VR intervention defined as at least 8 min before permanent discontinuation then feasibility will be met Ten minutes length is likely to be tolerated by most patients and likely to provide benefit The maximum length of the VR video is 11 minutes Patients will still be evaluable after 8 minutes of the video as this provides ample time to practice mindfulness based breathing exercises
As this is a feasibility study investigators and participants will not be blinded to study procedures Potential study participants will be adult patients who are undergoing simulation for radiation treatment planning at the Perelman Center for Advanced Medicine at Penn Medicine This is a single site study No interim analyses or sub-studies are planned Based on the expected accrual of 25 patients futility and early termination will be triggered if 6 participants fail to meet the conditions described above
As this is a feasibility study investigators and participants will not be blinded to study procedures Potential study participants will be adult patients who are undergoing simulation for radiation treatment planning at the Perelman Center for Advanced Medicine at Penn Medicine This is a single site study No interim analyses or sub-studies are planned Based on the expected accrual of 25 patients futility and early termination will be triggered if 6 participants fail to meet the conditions described above
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 854756 | OTHER | Penn IRB | None |