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NCT Number: NCT07072364

Videos to Aid Decision Making for Fibroid Treatment

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.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19010, United States

Location status: Recruiting

Location contact

Kirstin Leitner

CONTACT

[email protected]

651-492-3856

Kirstin Leitner, MD

PRINCIPAL_INVESTIGATOR

About this study

Decisional conflict is defined as personal uncertainty regarding which course of action to take when choice among different options involves risk, regret, or challenge to personal life values. Some factors that influence decisional conflict are inadequate knowledge, unclear values, inadequate support, and the perception that an ineffective decision has been made. In this study, the investigators hope to target the factor of inadequate knowledge to see if an educational-style video can decrease decisional conflict in patients with fibroids. This will be completed via assessment using a validated decisional conflict scale score the DCS-10. DCS-10 scores range from 0 to 100 with a larger number indicating a higher level of decisional conflict. Scores above 37.5 are associated with decision delay. Through improving knowledge via an educational video about fibroids, the investigators wish to determine if decisional conflict can be minimized.

This will be a randomized, single-blinded trial. Patients in the intervention arm will be sent an educational video on fibroids prior to their visit to discuss fibroid treatment options. All patients will receive routine clinical care and counseling regarding treatment options at their visit. After the visit, patients will complete a DCS-10 survey. Survey instruments will be sent via text message using the Way to Health platform, timed to automatically send based on appointment date.

Pilot data shows an average post-visit DCS-10 score of 29 within this gynecologic population. With the recommended effect size of 0.4 in the literature on DCS-10, a sample size of 154 patients is needed. The investigators anticipate study recruitment will take approximately six months. Individual participation in the study will begin when patients are sent an invitation to participate soon after scheduling a visit to discuss fibroid treatment. It will end with a post-visit DCS-10 survey within one week of the visit. The survey will take approximately 5 minutes to complete and the video duration is 5 minutes, for a total of 10 minutes of participant time after enrollment. Based on the time between scheduling and completing this visit, the time between enrollment and final survey collection will be approximately 1-12 weeks. Chart review will occur to capture treatment decisions within 12 weeks of visit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Video

Primary outcomes

  1. Decisional Conflict Scale

    Time frame: 1 weeks after appointment

    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.

Secondary outcomes

  1. Treatment selected

    Time frame: 12 weeks post appointment

    Patients will be assigned one of four treatment options based on documentation from initial consultation or from chart review within 12 weeks after appointment completion.

    • Expectant management, defined as no medical or surgical intervention
    • Medical management, defined as acceptance of prescribed medications such as oral contraceptive pills, GnRH modifiers (oral or injected), Injectable medications (such as Depo-Provera), Intrauterine devices.
    • Surgical management, defined as myomectomy or hysterectomy.
    • Other procedural management, defined as uterine artery embolization or high intensity focused ultrasound.

  2. Time to treatment

    Time frame: 12 weeks post appointment

    Patients time to selected treatment will be determined based on documentation within the medical chart with regards to acceptance of treatment.

    • Expectant management group, based on documentation within the medical record from initial visit.
    • Medical management group, based on the date of prescription of medication or date of documented decision for intrauterine device placement.
    • Surgical management group, based on the date of decision for surgical intervention as confirmed by scheduled procedure in chart.
    • Other procedural management group, based on the date of decision for management as confirmed by scheduled appointment in chart.

  3. Length of visit

    Time frame: Baseline

    Length of visit will be collected for all patients at baseline visit. This information is accessible by reviewing documented billing codes and documentation within the note from providers. Specifically for telehealth visits total minutes are available for all patients. If total time is not documented, pts will be assigned by level of visit billed to low end of the billable minutes.

    Level 2 10-19 min (assigned time would be 10 min) Level 3 20-29 min (assigned time would be 20 min) Level 4 30-39 min (assigned time would be 30 min) Level 5 40-54 min (assigned time would be 50 min)

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Graseck, MD

CONTACT

Kirstin Leitner, MD

CONTACT

[email protected]

651-492-3856

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • OptumRx

Registry information

Official study title

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

Acronym: Fibroid AUB

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 18, 2025
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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