Gynecologic Brachytherapy-Specific Educational Video

NCT ID: NCT04363957

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2022-04-22

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).

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

Conditions

Cervical Cancer; Uterine Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Standard Consent

Patients only receive the standard brachytherapy consent process

Group Type: OTHER

Standard Brachytherapy Consent Process

Intervention Type: OTHER

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

Standard Consent and Video Intervention

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

Group Type: EXPERIMENTAL

Brachytherapy video

Intervention Type: OTHER

Patients will watch a video that contains information about brachytherapy

Standard Brachytherapy Consent Process

Intervention Type: OTHER

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

Interventions

Brachytherapy video

Patients will watch a video that contains information about brachytherapy

Intervention Type: OTHER

Standard Brachytherapy Consent Process

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

Intervention Type: OTHER

Eligibility Criteria

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

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Jyoti Mayadev, MD

Associate Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jyoti Mayadev, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

Moores UC San Diego Cancer Center

La Jolla, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37247940 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

181519

Identifier Type: -

Identifier Source: org_study_id