Videos to Aid Decision Making for Fibroid Treatment

NCT ID: NCT07072364

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-12
• Study Completion Date: 2026-03-31

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.

Detailed Description

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.

Conditions

Uterine Bleeding; Decision Aid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Usual care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Video

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.

Group Type: EXPERIMENTAL

Video on uterine fibroids

Intervention Type: 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.

Interventions

Video on uterine fibroids

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Video

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OptumRx

UNKNOWN

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anuja Dokras, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kirstin Leitner, MD

Role: CONTACT

Kirstin.Leitner@pennmedicine.upenn.edu

651-492-3856

Anna Graseck, MD

Role: CONTACT

Facility Contacts

Kirstin Leitner

Role: primary

Kirstin.Leitner@pennmedicine.upenn.edu

651-492-3856

Other Identifiers

OBGYN-GYN-QI-1

Identifier Type: -

Identifier Source: org_study_id