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OpenTrials
Completed

NCT Number: NCT03081455

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Westwood Women's Health, Waterbury, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diagnostic Test

Diagnostic Test

Genetic Diagnostic Testing

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Myriad Genetic Laboratories, Inc.

Industry

Collaborators

  • Myriad Genetics, Inc.

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 16, 2017
Registry last updated
Aug 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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