Development of a Shared Decision Tool to Facilitate Uptake of the Levonorgestrel-releasing Intrauterine System for the Primary Prevention of Endometrial Cancer
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Survey using a questionnaire.
- Кому может быть актуально
- Состояния в реестре: Levonorgestrel, Intrauterine Systems, Prevention, Endometrial Cancer. Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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 \[LNG-IUS\]).
Подробное описание
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
Вмешательства
- Другое Survey using a questionnaire
Patient Preference Utility Assessment and Questionnaires
Первичные конечные точки
- Patient Utility Questionnaire [Срок оценки: Through study completion; an average of 1 year]
Критерии участия
Критерии включения
- 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
Критерии исключения
- N/A
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
США · 2 центра
- The Harris Health System (LBJ) — Houston
- MD Anderson Cancer Center — Houston
Идентификаторы
NCT: NCT07382583 · 2025-1540 · NCI-2026-00500