NCT04363957

Gynecologic Brachytherapy-Specific Educational Video

Completed NA Results posted Last updated 14 October 2025

What this trial tests

NA trial testing Brachytherapy video in Cervical Cancer in 80 participants. Completed in 22 April 2022.

Timeline

1 April 2020

Primary endpoint
22 April 2022

22 April 2022

Quick facts

Lead sponsor	University of California, San Diego
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	80
Start date	1 April 2020
Primary completion	22 April 2022
Estimated completion	22 April 2022
Sites	1 location across United States

Drugs / interventions tested

• Brachytherapy video
• Standard Brachytherapy Consent Process

Conditions studied

• Cervical Cancer — all drugs for Cervical Cancer →
• Uterine Cancer — all drugs for Uterine Cancer →

Sponsor

University of California, San Diego

Who can join

18 and older, female only, with Cervical Cancer or Uterine Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Patient Reported Satisfaction Primary · Baseline

Primary Analysis based on Intention-to-Treat population, defined as all individuals who were randomized to arm A or arm B. A Likert-scale study specific questionnaire (no unabbreviated scale title, Likert-scale is a general untitled tool) is used to calculate satisfaction score. Using the brachytherapy specific questionnaire, the study team will examine three patient reported time points for impact: baseline, after the consent process, and prior to the last brachytherapy procedure. For primary endpoint, a two-sample t-test will be used to compare differences of satisfaction scores at two time

Group	Value	95% CI
Standard Consent	54	45 – 54
Standard Consent and Video Intervention	55	49 – 55

Treatment Related Anxiety Secondary · Baseline

Satisfactory scores at three time points will be analyzed using a mixed effect model for repeated measures (MMRM) to assess satisfactory scores trajectories between two arms. The MMRM model will include terms for time, consent arm, baseline score, arm-by-time interaction, baseline score by time interaction, plus covariates that include age, stage. Time will be treated as categorical. If values of last two time points are similar, analysis of covariance model (ANCOVA) will be used to model the change in satisfactory scores. The mean of the last two time points will be calculated. That is, the a

Group	Value	95% CI
Standard Consent	4	2 – 7
Standard Consent and Video Intervention	4	1 – 6

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A randomized patient education trial investigating treatment-related distress and satisfaction with the use of an at-home gynecologic brachytherapy educational video.
   Kotha NV, Guram K, Morgan K, Deshler L, et al · · 2023 · cited 4× · PMID 37247940 · DOI 10.1136/ijgc-2023-004331