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

• ClinicalTrials.gov Identifier: NCT03081455
• Recruitment Status: Completed
• First Posted: March 16, 2017
• Last Update Posted: August 8, 2017
• Sponsor: Myriad Genetic Laboratories, Inc.
• Collaborator: Myriad Genetics, Inc.
• Information provided by (Responsible Party): Myriad Genetic Laboratories, Inc.

Study Description

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.

Condition or disease	Intervention/treatment
Hereditary Cancer	Diagnostic Test: Diagnostic Test

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 145 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: February 13, 2017
• Actual Primary Completion Date: July 7, 2017
• Actual Study Completion Date: August 4, 2017

Groups and Cohorts

Group/Cohort	Intervention/treatment
Women meeting guidelines for genetic testing; Women who present for an OB/GYN office visit (new patient visit, well woman visit, or problem visit) and who meet guidelines for genetic diagnostic testing will provide a blood or saliva sample for genetic diagnostic testing and complete a satisfaction survey.	Diagnostic Test: Diagnostic Test; Genetic Diagnostic Testing

Outcome Measures

Primary Outcome Measures :

1. The percentage of previously untested patients meeting guidelines who are offered genetic testing on site. [ Time Frame: Baseline ]
   The percentage of previously untested patients meeting guidelines who are offered genetic testing on site.

Secondary Outcome Measures :

1. The number of previously untested patients meeting guidelines who agree to undergo genetic testing without a pre-test referral to a genetic counselor. [ Time Frame: Baseline ]
   The number of previously untested patients meeting guidelines who agree to undergo genetic testing without a pre-test referral to a genetic counselor.

Biospecimen Retention:   Samples With DNA

Whole blood and saliva

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Women presenting for a well woman visit, new patient visit, or problem visit at participating OB/GYN practices during the 8-week Observation Period.

Criteria

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.

Contacts and Locations

Locations

United States, Connecticut

Westwood Women's Health

Waterbury, Connecticut, United States, 06708

United States, New York

Associates for Women's Medicine

Syracuse, New York, United States, 13203

Sponsors and Collaborators

Myriad Genetic Laboratories, Inc.

Myriad Genetics, Inc.

Investigators

• Study Director: Rocye T. Adkins, MD; Myriad Genetics, Inc.

More Information

• Responsible Party: Myriad Genetic Laboratories, Inc.
• ClinicalTrials.gov Identifier: NCT03081455
• Other Study ID Numbers: PC-005
• First Posted: March 16, 2017
• Last Update Posted: August 8, 2017
• Last Verified: August 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Disclosed via peer-reviewed journal

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Myriad Genetic Laboratories, Inc.:

Screening; Hereditary Cancer

Additional relevant MeSH terms:

Neoplastic Syndromes, Hereditary; Neoplasms; Genetic Diseases, Inborn