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NCT Number: NCT07382583

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

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]).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

MD Anderson Cancer Center, Houston, Texas, United States

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About this study

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:

  • To identify decisional needs, participant values, and experiences for preferences regarding LNG-IUS through a mixed-methods approach

Phase 2 Primary Objective:

  • 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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • N/A

Treatment and study plan

Survey using a questionnaire

Other

Patient Preference Utility Assessment and Questionnaires

Primary outcomes

  1. Patient Utility Questionnaire

    Time frame: Through study completion; an average of 1 year

Study contacts

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

Larissa A Meyer, MD

CONTACT

[email protected]

713-745-0973

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • Cancer Prevention Research Institute of Texas

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Feb 3, 2026
Registry last updated
Feb 25, 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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