Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-28 @ 12:24 AM
Study NCT ID:
NCT04363957
Status:
COMPLETED
Last Update Posted:
2025-10-14
First Post:
2020-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gynecologic Brachytherapy-Specific Educational Video
Sponsor:
University of California, San Diego
Organization:
Study Overview
Official Title:
Prospective, Randomized Evaluation of Patient Reported Knowledge and Satisfaction Following the Use of an Enhanced Gynecologic Brachytherapy-Specific Educational Video
Status:
COMPLETED
Status Verified Date:
2025-09
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:
Brachytherapy is a highly technical and integral component of the definitive treatment of gynecologic cancers \[1\]. To enhance provider communication and patient engagement, our study investigates a video consent on impact of patient treatment-related outcomes.
The study team will use a detailed brachytherapy video in addition to the standard brachytherapy verbal consent to evaluate patient-reported satisfaction and patient anxiety for gynecologic high-dose rate brachytherapy (a radiation procedure).
The study team will use a detailed brachytherapy video in addition to the standard brachytherapy verbal consent to evaluate patient-reported satisfaction and patient anxiety for gynecologic high-dose rate brachytherapy (a radiation procedure).
Detailed Description:
1:1 randomized trial using blocked randomization based on chronologic arrival in clinic, a group of patients will be randomized to the standard of care verbal consent (Arm A), or the standard of care consent plus the online brachytherapy informed video consent (Arm B). There will be three time points for the collection: After the standard consent process as the baseline, following the standard only vs standard and educational video consent process prior to the first brachytherapy procedure, and prior to the last brachytherapy procedure. The patients in the brachytherapy video consent process will be watching this online. The patient will be given a specific log in to use, and study researchers will be able to track the number of times the patient watches the video and the completion of the video view. The patient is allowed to watch the video as many times as desired
Study Oversight
Has Oversight DMC:
False
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?: