Gynecologic Brachytherapy-Specific Educational Video

September 22, 2025 updated by: Jyoti Mayadev, MD, University of California, San Diego

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • Moores UC San Diego Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient has the ability to understand and the willingness to sign a written informed consent.
  2. Patient must be female, all races and ethnic groups are eligible.
  3. Must be > 18 years of age, or have parental approval for inclusion.
  4. Must carry a diagnosis of gynecologic malignancy.
  5. Is deemed to require high-dose rate gynecologic brachytherapy procedure (intracavitary, hybrid intracavitary/interstitial, or interstitial).
  6. Any prior external beam radiation therapy is allowed.
  7. Any performance status is allowed.

  8. Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for # days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

    • A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

      • Has not undergone a hysterectomy or bilateral oophorectomy; or
      • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)

Exclusion Criteria:

  • 1. Patient has had prior high-dose rate gynecologic brachytherapy at any point in the past.

    2. . Patient is a non English speaker

    3. Patient is unable to watch the video

    4. Patient declines consent to the study

    5. Study-specific exclusion criteria.

    6. Patient has a severe or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to receive study treatment (i.e., uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, uncontrolled infection, psychiatric illness/social situations that would limit compliance with study requirements).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Standard Consent
Patients only receive the standard brachytherapy consent process
Other: Standard Brachytherapy Consent Process
Patients will have the standard clinical brachytherapy consent and education including discussion with their physician.
Experimental: Standard Consent and Video Intervention
Patients receive the standard brachytherapy consent process and the addition of an informational video about brachytherapy
Other: Standard Brachytherapy Consent Process
Patients will have the standard clinical brachytherapy consent and education including discussion with their physician.
Other: Brachytherapy video
Patients will watch a video that contains information about brachytherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Reported Satisfaction
Time Frame: 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 points (baseline and following consent process) between groups. The reporting scale is the following:

Strongly disagree (1); Disagree (2); Uncertain (3); Agree (4); Strongly agree (5)

Minimum: 1; Maximum: 5.

Questionnaire had 12 questions. Minimum possible score is 12; Maximum possible score is 60. Higher score means higher satisfaction.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Related Anxiety
Time Frame: 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 after consent score (mean values) will be regressed upon baseline score and consent arms. Patient treatment-related anxiety between groups, defined as National Comprehensive Cancer Network (NCCN) distress score, are also collected at three time points and will be analyzed using the same strategy. The NCCN distress scale is from 0 (min) -10 (max) with 10 being a value that is more distress- worse.
Baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Height (meters)
Time Frame: from study enrollment to the final dose of brachytherapy, up to 6 weeks
Participants height will be measured
from study enrollment to the final dose of brachytherapy, up to 6 weeks
Weight (kilograms)
Time Frame: from study enrollment to the final dose of brachytherapy, up to 6 weeks
Participants weight will be measured
from study enrollment to the final dose of brachytherapy, up to 6 weeks
Radiation Dose Administered (Gy)
Time Frame: At each dose from study enrollment to the final dose of brachytherapy, up to 6 weeks
Amount of radiation administered to the patient will be measured.
At each dose from study enrollment to the final dose of brachytherapy, up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Investigators

  • Principal Investigator: Jyoti Mayadev, MD, University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

April 22, 2022

Study Completion (Actual)

April 22, 2022

Study Registration Dates

First Submitted

April 3, 2020

First Submitted That Met QC Criteria

April 24, 2020

First Posted (Actual)

April 27, 2020

Study Record Updates

Last Update Posted (Estimated)

October 14, 2025

Last Update Submitted That Met QC Criteria

September 22, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 181519

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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