Actively Recruiting

Phase Not Applicable
Age: 18Years - 55Years
All Genders
ID07072364

The Use of Video Aids Versus Usual Care for Reduction in Decisional Conflict in Fibroid Treatment

Led by University of Pennsylvania · Updated on 2026-05-01

154

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Pennsylvania

Lead Sponsor

O

OptumRx

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether an educational video can help patients with uterine fibroids make clearer decisions about their treatment. Uterine fibroids often cause heavy or painful menstrual bleeding, and treatment options vary in effectiveness, side effects, and impact on future fertility. This randomized trial aims to see if watching a video about fibroids reduces personal uncertainty, measured by a decisional conflict scale, compared to usual care without the video. Participants will be randomly assigned to either receive a 5-minute educational video about fibroids before their scheduled outpatient visit or receive usual care without the video. All participants will still get regular clinical counseling during their visit. The video covers fibroid symptoms, diagnosis, and treatment choices. The study involves a single visit with follow-up surveys sent by text message after the visit. During the study, participants complete a decisional conflict survey within one week after their appointment, which takes about 5 minutes. Researchers will also review medical charts up to 12 weeks later to see which treatments patients chose and how long it took to start treatment. The total participation time after enrollment is approximately 10 minutes for watching the video and completing the survey, with follow-up lasting up to 12 weeks.

CONDITIONS

Brief Title

Videos to Aid Decision Making for Fibroid Treatment

Who Can Participate

Age: 18Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of uterine fibroids
  • Scheduled appointment to discuss fibroid management at an outpatient clinical site associated with the Hospital of the University of Pennsylvania
Not Eligible

You will not qualify if you...

  • Age under 18 or over 55
  • Uterine or cervical cancer
  • Cervical dysplasia grade 2-3 within the last 12 months
  • Pregnancy
  • Menopause
  • Decision made prior to study intake to have surgical treatment for fibroids

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Visit and Educational Video

Duration - 1 to 12 weeks

Participants receive routine clinical care and counseling regarding fibroid treatment options during an outpatient visit. Those in the intervention group will watch a 5-minute educational video about uterine fibroids before their appointment to help reduce decisional conflict.

1 outpatient visit and completion of surveys sent via text message

Post-Visit Follow-up

Duration - Up to 12 weeks

Participants complete a decisional conflict survey within one week after their outpatient visit and have their treatment choices and time to treatment monitored up to 12 weeks post-visit.

Surveys sent via text message; no in-person visits required

Trial Site Locations

Total: 1 location

1

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19010

Actively Recruiting

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Research Team

K

Kirstin Leitner, MD

A

Anna Graseck, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

2

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