Clinical trial NCT03081455: Impact of a Process Intervention on Screening and Testing Outcomes for Common Hereditary Cancer Syndromes
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hereditary Cancer
Keywords: Screening
Hereditary Cancer
Lead sponsor: Myriad Genetic Laboratories, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Myriad Genetics, Inc.
First posted: 2017-03-16
Enrollment: 145
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: The percentage of previously untested patients meeting guidelines who are offered genetic testing on site.
timeFrame: Baseline
Secondary outcomes:
measure: The number of previously untested patients meeting guidelines who agree to undergo genetic testing without a pre-test referral to a genetic counselor.
timeFrame: Baseline
Other outcomes:
Locations:
city: Waterbury
country: United States
facility: Westwood Women's Health
state: Connecticut
city: Syracuse
country: United States
facility: Associates for Women's Medicine
state: New York
Study officials:
affiliation: Myriad Genetics, Inc.
name: Rocye T. Adkins, MD
role: STUDY_DIRECTOR
References: