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

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.

Study Overview

• Status: Completed
• Conditions: Hereditary Cancer
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 145

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Westwood Women's Health
  • New York
    • Syracuse, New York, United States, 13203
      • Associates for Women's Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Myriad Genetic Laboratories, Inc.
• Collaborators: Myriad Genetics, Inc.
• Investigators: Study Director: Rocye T. Adkins, MD, Myriad Genetics, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 13, 2017
• Primary Completion (ACTUAL): July 7, 2017
• Study Completion (ACTUAL): August 4, 2017

Study Registration Dates

• First Submitted: March 1, 2017
• First Submitted That Met QC Criteria: March 10, 2017
• First Posted (ACTUAL): March 16, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 8, 2017
• Last Update Submitted That Met QC Criteria: August 7, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Screening; Hereditary Cancer
• Additional Relevant MeSH Terms: Neoplasms; Genetic Diseases, Inborn; Neoplastic Syndromes, Hereditary
• Other Study ID Numbers: PC-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Disclosed via peer-reviewed journal

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No