Impact of a Process Intervention on Screening and Testing Outcomes for Common Hereditary Cancer Syndromes

Hereditary Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03081455
• Other study ID #: PC-005
• Status: Completed
• Phase: N/A
• First received: March 1, 2017
• Last updated: August 7, 2017
• Start date: February 13, 2017
• Est. completion date: August 4, 2017

Study information

• Verified date: August 2017
• Source: Myriad Genetic Laboratories, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 OB/GYN settings.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: August 4, 2017
• Est. primary completion date: July 7, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Hereditary Cancer
• Neoplastic Syndromes, Hereditary

Intervention

Diagnostic Test:
• Diagnostic Test
Genetic Diagnostic Testing

Locations

Country	Name	City	State
United States	Associates for Women's Medicine	Syracuse	New York
United States	Westwood Women's Health	Waterbury	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Myriad Genetic Laboratories, Inc.	Myriad Genetics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of previously untested patients meeting guidelines who are offered genetic testing on site.	The percentage of previously untested patients meeting guidelines who are offered genetic testing on site.	Baseline
Secondary	The number of previously untested patients meeting guidelines who agree to undergo genetic testing without a pre-test referral to a genetic counselor.	The number of previously untested patients meeting guidelines who agree to undergo genetic testing without a pre-test referral to a genetic counselor.	Baseline