Videos to Aid Decision Making for Fibroid Treatment

NCT07072364 | Recruiting

• 1 other identifier: OBGYN-GYN-QI-1
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

Uterine fibroids are a common condition that can cause heavy and/or painful menstrual bleeding. There are many treatment options, but they vary in efficacy, side effects, short-term recovery and long-term implications for future fertility. Patients can have difficulty deciding between these options. In this study, the investigators will randomly assign patients seeking treatment for fibroids to receive an educational video on fibroids and their treatment, versus usual care (no video). The investigators will assess their decisional conflict with and without exposure to the video using a validated survey to see if exposure to the educational video helps them make decisions.

Conditions

Decision Aid; Uterine Bleeding

Keywords

Abnormal uterine bleeding; Uterine fibroids; Decisional Conflict Scale; Educational videos

Outcome Measures

Primary Outcomes (1)

• Decisional Conflict Scale

  Patients complete a 10 question Decisional Conflict Scale 10 Item Version (DCS-10) via text message up to 1 week after their completed appointment. Each of the 10 questions asks patients on a 0-5 Likert scale. Higher scores indicate more decisional conflict. Minimum score of 0 = no decisional conflict. Maximum score of 40 = high decisional conflict.

  1 weeks after appointment

Secondary Outcomes (3)

• Treatment selected

  12 weeks post appointment

• Time to treatment

  12 weeks post appointment

• Length of visit

  Baseline

Study Arms (2)

Usual care

NO INTERVENTION

Patients will receive no additional education prior to their scheduled appointment to discuss uterine fibroids.

Video

EXPERIMENTAL

Patients in this arm will receive a 5 minute educational video regarding symptoms, diagnosis and management options of uterine fibroids prior to their scheduled outpatient visit.

Behavioral: Video on uterine fibroids

Interventions

Video on uterine fibroids BEHAVIORAL

Patients will be sent a link to a 5 minute video on uterine fibroids including their diagnosis, symptoms and treatment options prior to their scheduled appointment.

Also known as: Video

Video

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• OptumRx: collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19010, United States

RECRUITING

MeSH Terms

Conditions

Uterine Hemorrhage; Metrorrhagia; Leiomyoma

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Anuja Dokras, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirstin Leitner, MD

CONTACT

651-492-3856; Kirstin.Leitner@pennmedicine.upenn.edu

Anna Graseck, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to either receive an educational video or not. The patients decisional conflict will be measured after receiving the intervention or not.

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: July 18, 2025
• Study Start: March 12, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)