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

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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03081455

Enrollment

145

Registered

2017-03-16

Start date

2017-02-13

Completion date

2017-08-04

Last updated

2017-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hereditary Cancer

Keywords

Screening, Hereditary Cancer

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 OB/GYN 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 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.

Interventions

DIAGNOSTIC_TESTDiagnostic Test

Genetic Diagnostic Testing

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
The percentage of previously untested patients meeting guidelines who are offered genetic testing on site.	Baseline	The percentage of previously untested patients meeting guidelines who are offered genetic testing on site.

Secondary

Measure	Time frame	Description
The number of previously untested patients meeting guidelines who agree to undergo genetic testing without a pre-test referral to a genetic counselor.	Baseline	The number of previously untested patients meeting guidelines who agree to undergo genetic testing without a pre-test referral to a genetic counselor.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026