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

August 11, 2026 updated by: M.D. Anderson Cancer Center
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]).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

270

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Larissa A Meyer, MD
      • Houston, Texas, United States, 77026
        • Recruiting
        • The Harris Health System (LBJ)
        • Principal Investigator:
          • Larissa Meyer, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

MD Anderson Cancer Center

Description

This study will include participants from three categories: Unaffected women, Affected women, and Healthcare Providers. The eligibility criteria for each group are listed below:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Phase 1
Identify decisional needs, patient values and experiences
Other: Survey using a questionnaire
Patient Preference Utility Assessment and Questionnaires
Phase 2
Develop and pilot test a web-based shared medical decision tool
Other: Survey using a questionnaire
Patient Preference Utility Assessment and Questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient Utility Questionnaire
Time Frame: Through study completion; an average of 1 year
Through study completion; an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

Cancer Prevention Research Institute of Texas

Investigators

  • Principal Investigator: Larissa A Meyer, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2030

Study Registration Dates

First Submitted

January 22, 2026

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

February 3, 2026

Study Record Updates

Last Update Posted (Actual)

August 12, 2026

Last Update Submitted That Met QC Criteria

August 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-1540
  • NCI-2026-00500 (Other Identifier: NCI-CTRP Clinical Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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