Prospective Randomized Trial of Streamlined Genetic Education and Testing for Ovarian Cancer Patients

NACompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

August 8, 2019

Primary Completion Date

July 31, 2021

Study Completion Date

July 31, 2021

Conditions
Ovarian Cancer, EpithelialPeritoneal CancerFallopian Tube Cancer
Interventions
BEHAVIORAL

Streamlined Education

After completion of the baseline surveys, the SG subjects will watch an approximately eight minute long genetics education video. This video will be made with the assistance of Duke University genetic counselors and gynecologic oncology providers. It will consist of a discussion of genes and mutations, the recommendation of universal testing for high grade epithelial ovarian cancer, a review of genes associated with ovarian cancer predisposition, the possibility of uncertain results including variants of undetermined significance, the potential for undetected mutations in known or unknown cancer susceptibility genes, the potential impact on personal treatment and on family members, the possibility of genetic discrimination and the legal protection of genetic information.

BEHAVIORAL

Traditional Education

The TG subjects will then meet with the genetic counselor at the previously scheduled appointment time. During this visit, they will receive approximately thirty to sixty minutes of counseling regarding genetic testing and potential results. The discussion is based on the American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN) guidelines of informed consent for genetic testing. After counseling, participants will be given the option to undergo a multi-gene panel genetic test either via saliva or blood sample. Those who agree to testing will also complete the standard genetic testing consent form. As per standard practice of the clinical genetic service at DCI, patients will also be asked to provide consent for somatic tumor testing of surgical specimen (non-cytologic).

Trial Locations (1)

27710

Duke University Health System, Durham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Duke University

OTHER