Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Uterine Cancer | Malignant Uterine Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brachytherapy video | Other | — | UNRESOLVED |
| Standard Brachytherapy Consent Process | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Standard Consent
- description
- Patients only receive the standard brachytherapy consent process
- interventionNames
- Other: Standard Brachytherapy Consent Process
- type
- EXPERIMENTAL
- label
- Standard Consent and Video Intervention
- description
- Patients receive the standard brachytherapy consent process and the addition of an informational video about brachytherapy
- interventionNames
- Other: Brachytherapy video
- Other: Standard Brachytherapy Consent Process
Primary outcomes (1)
- measure
- Patient Reported Satisfaction
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
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).References
Publications (1)
- DERIVEDKotha 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