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

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

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genetic Testing

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




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


Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03081455


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

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Responsible Party: Myriad Genetic Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT03081455     History of Changes
Other Study ID Numbers: PC-005
First Posted: March 16, 2017    Key Record Dates
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

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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:
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Neoplastic Syndromes, Hereditary
Neoplasms
Genetic Diseases, Inborn