Educational Video for Uterine Fibroids

(Fibroid AUB Trial)

Overseen By Kirstin Leitner, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Age <18 or >55, Cancer, Pregnancy, Menopause, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

154 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether an educational video can assist people with uterine fibroids in making better treatment decisions. Uterine fibroids are non-cancerous growths in the uterus that can cause heavy and painful periods. Participants will either watch a video about fibroids or receive standard care without the video. Researchers aim to determine if the video reduces decision-making stress. Eligible participants have been diagnosed with uterine fibroids and have an upcoming appointment to discuss treatment at a specific hospital. As an unphased trial, this study offers a unique opportunity to contribute to research that may enhance decision-making tools for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on educational videos rather than medication changes.

What prior data suggests that this educational video is safe for patients seeking treatment for uterine fibroids?

Research has shown that educational videos about uterine fibroids are generally helpful and well-liked. Since these videos aim to provide information, they do not present direct evidence about safety. They do not involve drugs or medical procedures that could cause side effects, so there are no safety concerns like those associated with medical treatments. The videos aim to help patients understand fibroids and their treatment options better, assisting in making informed decisions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of an educational video on uterine fibroids, a condition typically managed with medication, surgery, or other procedures. Unlike traditional treatments that focus on physically altering or removing fibroids, this approach aims to empower patients with knowledge about symptoms, diagnosis, and management options. By providing this information in a concise, accessible format before an appointment, the video could enhance patient understanding and engagement, potentially leading to better outcomes and more informed decision-making. This method could revolutionize how patients participate in their own care, making it a valuable addition to existing treatment strategies.

What evidence suggests that this educational video is effective for uterine fibroids?

Studies have shown that educational videos can help people make better health decisions. In this trial, participants in the video arm will watch a 5-minute educational video about uterine fibroids to understand the symptoms, diagnosis, and treatment options available. Research shows that these videos provide clearer and more useful information than personal story videos. By offering reliable and high-quality content, these videos can reduce uncertainty and anxiety, leading to more informed and confident decision-making for those considering fibroid treatment. ^{1 3 4 6 7}

Who Is on the Research Team?

Anuja Dokras, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for individuals experiencing heavy or painful menstrual bleeding due to uterine fibroids. Participants should be seeking treatment options and willing to complete surveys about their decision-making process.

Inclusion Criteria

I have been diagnosed with uterine fibroids.

I have an appointment at a clinic linked to the University of Pennsylvania Hospital for fibroid management.

Exclusion Criteria

Pregnancy

I have gone through menopause.

I have decided to undergo surgery for my fibroids before joining the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-12 weeks

Intervention

Participants receive an educational video on fibroids or usual care prior to their visit

1 week

1 visit (in-person)

Follow-up

Participants complete a DCS-10 survey to assess decisional conflict after their visit

1 week

Chart Review

Chart review to capture treatment decisions within 12 weeks of visit

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Video on uterine fibroids

Trial Overview The study tests whether an educational video on uterine fibroids and treatment options can help patients make more informed decisions, compared to the usual care without a video.

How Is the Trial Designed?

Group I: Video Experimental Treatment 1 Intervention

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 II: Usual care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

OptumRx

Collaborator

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10788432/

Virtual reality education program for women with uterine ... The VR education program is an educational nursing intervention that reduces uncertainty and anxiety and improves nursing satisfaction among women with uterine ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07072364

Videos to Aid Decision Making for Fibroid Treatment Patients in this arm will receive a 5 minute educational video regarding symptoms, diagnosis and management options of uterine fibroids prior to ...

3. cureus.com cureus.com/articles/384424-quality-and-reliability-of-tiktok-videos-on-uterine-fibroid-embolizations-an-observational-analysis-of-internationally-trending-social-media-videos

Quality and Reliability of TikTok Videos on Uterine Fibroid ... Educational videos (35, 35.35%) outperformed anecdotal ones (59, 59.59%) in quality, achieving higher DISCERN (40.57) and PEMAT ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1546144022002794

Quality and Reliability of YouTube Videos on Uterine ... The safety and efficacy of uterine fibroid embolization (UFE) in reducing menorrhagia and bulk symptoms has been substantiated by randomized controlled trials.

5. researchgate.net researchgate.net/publication/356652182_Quality_and_Reliability_of_YouTube_Videos_on_Surgical_Treatment_of_Uterine_Leiomyomas

(PDF) Quality and Reliability of YouTube Videos on ... PDF | Introduction To determine the quality of English language YouTube videos on uterine leiomyomas (UL) and their surgical treatment.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8717934/

Quality and Reliability of YouTube Videos on Surgical ... Abstract. Introduction. To determine the quality of English language YouTube videos on uterine leiomyomas (UL) and their surgical treatment.

7. asrm.org asrm.org/news-and-events/asrm-news/latest-news/july-10-25---sig-spotlight/

SIG Spotlight: FSIG The Fibroid SIG is dedicated to improving care for patients with uterine fibroids through research, education, and collaboration.