跳至主要内容
临床试验/NCT03081455
NCT03081455已完成不适用

A Prospective Evaluation of the Impact of a Process Engineering Intervention on Screening and Testing Outcomes for Common Hereditary Cancer Syndromes in Community-Based Obstetrics and Gynecology Settings

Myriad Genetic Laboratories, Inc.2 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2017年2月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
145
试验地点
2
主要终点
The percentage of previously untested patients meeting guidelines who are offered genetic testing on site.

研究概览

简要总结

A prospective, non-interventional study to evaluate the impact of a process engineering intervention on screening and testing outcomes for common hereditary cancer syndromes in community-based OB/GYN settings.

详细描述

This is a prospective process intervention study that will compare historical pre-process intervention data to post-intervention data from study providers within participating community obstetrics and gynecology practices. This study will begin with a process intervention at the participating practices during which Myriad Genetics personnel experienced in implementation of hereditary cancer risk assessment programs will provide training to practice providers. The training will be followed by a 4-week practice period to allow for incorporation of the recommendations of the intervention process into the practice. During a subsequent 8-week Observation period, women who present for an office visit (new patient visit, well women visit, or problem visit) will be screened for common hereditary cancer syndromes following the process established during the process intervention. Patients who meet NCCN/ACOG testing guidelines will be offered genetic testing. Patients and study providers will be surveyed about their satisfaction with the hereditary cancer risk assessment process.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patient who presents for a new patient gynecologic visit, well woman exam, or problem gynecologic visit and meets guidelines (HBOC-NCCN guidelines; Lynch syndrome-SGO/ACOG guidelines) for genetic testing
  • Patient who is 18 years of age or older
  • Able to understand informed consent and agrees to participate

排除标准

  • Patient who has previously undergone BRCA1/2, Lynch syndrome genetic testing, or multi-gene, pan-cancer, or panel testing
  • Patient who is not pregnant
  • Patient who is unwilling or unable to provide informed consent.

结局指标

主要结局

The percentage of previously untested patients meeting guidelines who are offered genetic testing on site.

时间窗: Baseline

The percentage of previously untested patients meeting guidelines who are offered genetic testing on site.

次要结局

  • The number of previously untested patients meeting guidelines who agree to undergo genetic testing without a pre-test referral to a genetic counselor.(Baseline)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验