Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Patients only receive the standard brachytherapy consent process

Patients receive the standard brachytherapy consent process and the addition of an informational video about brachytherapy

Patients will watch a video that contains information about brachytherapy

Brachytherapy video

Patients will have the standard clinical brachytherapy consent and education including discussion with their physician.

Standard Brachytherapy Consent Process

Jyoti Mayadev, MD

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).

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

In this open-label study design, eligible participants will be randomized using a simple 1:1 schedule to either brachytherapy verbal standard consent (Arm A), or the brachytherapy specific video (Arm B), based on chronological arrival in clinic

Evaluation of Patient Reported Knowledge and Satisfaction Following the Use of an Enhanced 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

Amount of radiation administered to the patient will be measured.

The primary analysis will be based on the Intention-to-Treat population, defined as all individuals who were randomized to arm A or arm B. A Likert-scale questionnaire 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. It is not anticipated that there are any possible confounders, if any study team will include it in the secondary analysis.The reporting scale is the following:

Strongly disagree (1) Disagree (2) Uncertain (3) Agree (4) Strongly agree (5) A higher score means a better outcome

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 NCCN distress score, are also collected at three time points and will be analyzed using the same strategy. The NCCN distress scale is from 0-10 with 10 being a value that is more distress- worse.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluation of Patient Reported Knowledge and Satisfaction Following the Use of an Enhanced Gynecologic Brachytherapy-Specific Educational Video	NCT04363957	Cervical Cancer Uterine Cancer	Brachytherapy v... Standard Brachy...	18 Years -	University of California, San Diego
Evaluation of Patient Reported Knowledge and Satisfaction Following the Use of an Enhanced Gynecologic Brachytherapy-Specific Educational Video	NCT04363957	Cervical Cancer Uterine Cancer	Brachytherapy v... Standard Brachy...	18 Years -	University of California, San Diego

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