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
|Condition or disease||Intervention/treatment|
|Hereditary Cancer||Diagnostic Test: Diagnostic Test|
|Study Type :||Observational|
|Actual Enrollment :||145 participants|
|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|
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
- 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.
- 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
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
|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|
|Study Director:||Rocye T. Adkins, MD||Myriad Genetics, Inc.|