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

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

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

• 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