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Prospective, Randomized Non-inferiority Trial of Streamlined Genetic Education and Testing for High-grade Epithelial Ovarian, Fallopian and Peritoneal Cancer Patients
Current guidelines recommend universal genetic testing for all patients with ovarian, fallopian and peritoneal cancer. The purpose of this trial is to investigate the non-inferiority of streamlined genetics education and testing for this patient population when compared to the traditional model of referral to genetic counseling. Patients will be randomized to either the streamlined or the traditional counseling arm. Those in the streamlined group will watch a brief educational video and have the option of immediate testing; The traditional counseling arm will instead be referred for a formal genetics consultation, after which they can choose to be tested. The primary outcome will be a patient reported outcome scale that assesses patient satisfaction with genetic counseling; patient anxiety and distress and cost effectiveness when using both strategies will also be evaluated. The study poses minimal risk to the patients that would not be encountered during standard of care genetic counseling.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Duke University Health System
Durham, North Carolina, United States
Start Date
August 8, 2019
Primary Completion Date
July 31, 2021
Completion Date
July 31, 2021
Last Updated
August 26, 2021
64
ACTUAL participants
Streamlined Education
BEHAVIORAL
Traditional Education
BEHAVIORAL
Lead Sponsor
Duke University
NCT05281471
NCT04657068
Data Source & Attribution
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