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

N/ANot Yet RecruitingNCT07382583

M.D. Anderson Cancer Center270 enrolled

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 \[LNG-IUS\]).

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

270

Conditions

Levonorgestrel Intrauterine Systems Prevention Endometrial Cancer

Interventions

Survey using a questionnaireOTHER

Patient Preference Utility Assessment and Questionnaires

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

The Harris Health System (LBJ)

Houston, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Patient Utility Questionnaire

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

Central Contacts

Larissa A Meyer, MD

CONTACT

713-745-0973 lmeyer@mdanderson.org

Data from ClinicalTrials.gov

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