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

Status: Begins enrollment in 5 months

Conditions: Endometrial Cancer; Prevention; Levonorgestrel; Intrauterine Systems

Treatments: Other: Survey using a questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT07382583

2025-1540

NCI-2026-00500 (Other Identifier)

Details and patient eligibility

About

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]).

Full 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

Enrollment: 270 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

270 participants in 2 patient groups

Phase 1

Description:

Identify decisional needs, patient values and experiences

Treatment:

Other: Survey using a questionnaire

Phase 2

Description:

Develop and pilot test a web-based shared medical decision tool

Treatment:

Other: Survey using a questionnaire