NCT07382583

Development of a Shared Decision Tool to Facilitate Uptake of the Levonorgestrel-releasing Intrauterine System for the Primary Prevention of Endometrial Cancer

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 270 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To develop an educational tool to help patients and healthcare professionals make informed decisions about endometrial cancer and available prevention options for it (such as the use of a levonorgestrel-releasing intrauterine system \[LNG-IUS\]).

Detailed description

Primary Objectives The overall goal of this study is to create a personalized decision support educational tool for the use of LNG-IUS as a primary prevention strategy for women at risk of EC. The decision support tool will not replace the consultation with a clinician. Rather, it will help prepare the participant to better understand their options and prepare them for conversations with clinicians when making a decision about use of LNG-IUS. The primary objectives will be accomplished in two phases: Phase 1 Primary Objective: 1\. To identify decisional needs, participant values, and experiences for preferences regarding LNG-IUS through a mixed-methods approach Phase 2 Primary Objective: 1\. To develop and field-test a novel web-based SDM tool in English and Spanish incorporating a personalized EC risk calculator and focused on LNG-IUS as a primary prevention strategy

Conditions

• Levonorgestrel
• Intrauterine Systems
• Prevention
• Endometrial Cancer

Interventions

Type	Name	Description
OTHER	Survey using a questionnaire	Patient Preference Utility Assessment and Questionnaires

Timeline

• Start date: 2026-02-12
• Primary completion: 2028-02-01
• Completion: 2030-02-01
• First posted: 2026-02-03
• Last updated: 2026-02-25

Locations

2 sites across 1 country: United States