NCT07382583Recruiting

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

M.D. Anderson Cancer Center

Start Date

2/12/2026

Completion Date

2/1/2030

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

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Unaffected women 1. Must be at least 18 years old 2. Must read and speak English or Spanish 3. Must be premenopausal 4. Must not have a prior history of EC or complex atypical hyperplasia 5. Must provide written, informed consent 6. No physical, psychological, or cognitive impairments that would preclude participation in an interview as determined by the PI or study team member 2. Affected women 1. Must be at least 18 years old 2. Must read and speak English or Spanish 3. Must have a prior history of EC or complex atypical hyperplasia 4. Must provide written, informed consent 5. No physical, psychological, or cognitive impairments that would preclude participation in an interview as determined by the PI or study team member 3. Healthcare Providers 1. Physicians or advanced practice providers (physician assistants, nurse practitioners) from Family Medicine, Obstetrics \& Gynecology, Internal Medicine, or Endocrinology 2. Must be at least 18 years old 3. Must read and speak English or Spanish 4. Must provide written, informed consent for qualitative interviews Exclusion Criteria: * N/A

Interventions

OTHER

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Conditions

LevonorgestrelIntrauterine SystemsPreventionEndometrial Cancer

Locations

The Harris Health System (LBJ)

Houston, Texas 77026

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States