Development of a Shared Decision Tool to Facilitate Uptake of the Levonorgestrel-releasing Intrauterine System for the Primary Prevention of Endometrial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- Patient Utility Questionnaire
研究概览
简要总结
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]).
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Phase 2
Develop and pilot test a web-based shared medical decision tool
干预措施: Survey using a questionnaire (Other)
Phase 1
Identify decisional needs, patient values and experiences
干预措施: Survey using a questionnaire (Other)
结局指标
主要结局
Patient Utility Questionnaire
时间窗: Through study completion; an average of 1 year
次要结局
未报告次要终点