Gynecologic Brachytherapy-Specific Educational Video

NCT04363957 | Completed Results

• 1 other identifier: 181519
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Cervical Cancer; Uterine Cancer

Outcome Measures

Primary Outcomes (1)

• Patient Reported Satisfaction

  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 Outcomes (1)

• Treatment Related Anxiety

  Baseline

Study Arms (2)

Standard Consent

OTHER

Patients only receive the standard brachytherapy consent process

Other: Standard Brachytherapy Consent Process

Standard Consent and Video Intervention

EXPERIMENTAL

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

Other: Brachytherapy video; Other: Standard Brachytherapy Consent Process

Interventions

Brachytherapy video OTHER

Patients will watch a video that contains information about brachytherapy

Standard Consent and Video Intervention

Standard Brachytherapy Consent Process OTHER

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

Standard Consent; Standard Consent and Video Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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:

• \. 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
• \. 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).

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

Moores UC San Diego Cancer Center

La Jolla, California, 92093, United States

Location

Related Publications (1)

• Kotha NV, Guram K, Morgan K, Deshler L, Brown D, Rash D, Dyer B, McHale M, Yashar C, Scanderbeg D, Einck J, Mayadev J. A randomized patient education trial investigating treatment-related distress and satisfaction with the use of an at-home gynecologic brachytherapy educational video. Int J Gynecol Cancer. 2023 Jul 3;33(7):1125-1131. doi: 10.1136/ijgc-2023-004331.

  PMID: 37247940 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Dr. Jyoti Mayadev
• Organization: University of California, San Diego

CancerCTO@health.ucsd.edu

(858) 822-5354

Study Officials

• Jyoti Mayadev, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor

Model Details: 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

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 27, 2020
• Study Start: April 1, 2020
• Primary Completion: April 22, 2022
• Study Completion: April 22, 2022
• Last Updated: October 14, 2025
• Results First Posted: October 14, 2025

Record last verified: 2025-09

Locations

US (1)