Status:
COMPLETED
Gynecologic Brachytherapy-Specific Educational Video
Lead Sponsor:
University of California, San Diego
Conditions:
Cervical Cancer
Uterine Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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).
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04363957
Start Date
April 1 2020
End Date
April 22 2022
Last Update
October 14 2025
Active Locations (1)
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1
Moores UC San Diego Cancer Center
La Jolla, California, United States, 92093