Video to help you choose a fibroid treatment
The Use of Video Aids Versus Usual Care for Reduction in Decisional Conflict in Fibroid Treatment
This project will test whether sending an educational video to people with uterine fibroids before their clinic visit helps them feel more certain about choosing a treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 154 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT07072364 on ClinicalTrials.gov |
What this trial studies
In this randomized, single-blinded trial at the Hospital of the University of Pennsylvania, patients with uterine fibroids scheduled for an outpatient visit are randomly assigned to receive an educational video about fibroid treatments or to usual care without the video. All participants receive routine counseling at their visit, and after the visit they complete the DCS-10 decisional conflict survey delivered by text via the Way to Health platform. The primary outcome is the post-visit DCS-10 score (0–100) with higher scores indicating greater decisional conflict and scores above 37.5 linked to decision delay. Pilot data suggest an average post-visit DCS-10 score of 29, and the investigators aim to see if the video reduces decisional conflict compared with usual care.
Who should consider this trial
Good fit: Adults aged 18–55 with diagnosed uterine fibroids who have a scheduled outpatient appointment at the Hospital of the University of Pennsylvania and have not already decided on surgery are ideal candidates.
Not a fit: People who are pregnant, menopausal, have uterine or cervical cancer, recent high-grade cervical dysplasia, are older than 55, or have already chosen a surgical treatment are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the video could reduce patients' uncertainty about treatment choices and shorten delays in making a decision.
How similar studies have performed: Decision aids and educational videos for other medical decisions have often reduced decisional conflict in prior studies, though video-specific evidence for fibroid treatment is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of uterine fibroids * Scheduled appointment to discuss management of fibroids in an outpatient clinical site associated with the Hospital of the University of Pennsylvania Exclusion Criteria: * Age \<18 or \>55 * Uterine or cervical cancer * Cervical dysplasia grade 2-3 within the last 12 mo * Pregnancy * Menopause * Decision made prior to the study intake to have a surgical procedure for treatment of fibroids
Where this trial is running
Philadelphia, Pennsylvania
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Anuja Dokras, MD — University of Pennsylvania
- Study coordinator: Kirstin Leitner, MD
- Email: Kirstin.Leitner@pennmedicine.upenn.edu
- Phone: 651-492-3856
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.