NCT04363957

Gynecologic Brachytherapy-Specific Educational Video

Prospective, Randomized Evaluation of Patient Reported Knowledge and Satisfaction Following the Use of an Enhanced Gynecologic Brachytherapy-Specific Educational Video

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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

Conditions

• Cervical Cancer
• Uterine Cancer

Interventions

Type	Name	Description
OTHER	Brachytherapy video	Patients will watch a video that contains information about brachytherapy
OTHER	Standard Brachytherapy Consent Process	Patients will have the standard clinical brachytherapy consent and education including discussion with their physician.

Timeline

• Start date: 2020-04-01
• Primary completion: 2022-04-22
• Completion: 2022-04-22
• First posted: 2020-04-27
• Last updated: 2025-10-14
• Results posted: 2025-10-14

Locations

1 site across 1 country: United States