Gynecologic Brachytherapy-Specific Educational Video

Completed · Not applicable

Conditions studied: Cervical Cancer, Uterine Cancer

In brief

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).

Key facts

Study ID

NCT04363957

Run by

University of California, San Diego

People needed

80

Starts

2020-04-01

Expected to finish

2022-04-22

Last updated by the study team

2025-10-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 1. Patient has had prior high-dose rate gynecologic brachytherapy at any point in the past.
• . Patient is a non English speaker
• Patient is unable to watch the video
• Patient declines consent to the study
• Study-specific exclusion criteria.
• 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).

Where it is running

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

Full record on ClinicalTrials.gov

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