Development of a Shared Decision Tool to Facilitate Uptake of the Levonorgestrel-releasing Intrauterine System for the Primary Prevention of Endometrial Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Survey using a questionnaire.
- Who it may be relevant to
- Registry conditions: Levonorgestrel, Intrauterine Systems, Prevention, Endometrial Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Other Survey using a questionnaire
Patient Preference Utility Assessment and Questionnaires
Primary outcome measures
- Patient Utility Questionnaire [Time frame: Through study completion; an average of 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 2 centers
- The Harris Health System (LBJ) — Houston
- MD Anderson Cancer Center — Houston
Identifiers
NCT: NCT07382583 · 2025-1540 · NCI-2026-00500