Prospective Randomized Trial of Streamlined Genetic Education and Testing for Ovarian Cancer Patients
Completed · Not applicable
Conditions studied: Ovarian Cancer, Epithelial, Peritoneal Cancer, Fallopian Tube Cancer
In brief
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.
Key facts
- Study ID
- NCT04537702
- Run by
- Duke University
- People needed
- 64
- Starts
- 2019-08-08
- Expected to finish
- 2021-07-31
- Last updated by the study team
- 2021-08-26
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Either a) pathologically confirmed diagnosis of high-grade epithelial ovarian, fallopian or peritoneal cancer via biopsy or surgical pathology or b) cytologic diagnosis consistent with high-grade epithelial ovarian cancer.
- Presenting to Duke gynecologic oncology clinic or collaborating institution for first outpatient visit following pathologic or cytologic diagnosis. If logistic constraints prevent the patient from being enrolled at her initial visit, she will be eligible for enrollment up to initiation of her fifth cycle of chemotherapy.
You may not qualify if…
- Known family or personal history of an inherited cancer susceptibility mutation
- Previously received genetic counseling or testing for an inherited cancer susceptibility mutation
- Insurance provided by an insurance company that requires face-to-face genetic consultation prior to testing
- Unable to read or speak English as study design includes video assisted educational materials in English
- Blind or deaf as study design includes video assisted educational materials in English
Where it is running
- Duke University Health System — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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