Ignite Creation Date:
2024-05-06 @ 9:50 AM
Last Modification Date:
2024-10-26 @ 12:20 PM
Study NCT ID:
NCT03081455
Status:
COMPLETED
Last Update Posted:
2017-08-08
First Post:
2017-03-01
Brief Title:
Impact of a Process Intervention on Screening and Testing Outcomes for Common Hereditary Cancer Syndromes
Sponsor:
Myriad Genetic Laboratories Inc
Organization:
Myriad Genetic Laboratories Inc
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 OBGYN settings
Detailed Description:
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 NCCNACOG testing guidelines will be offered genetic testing Patients and study providers will be surveyed about their satisfaction with the hereditary cancer risk assessment process
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None