NCT04537702

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

Prospective, Randomized Non-inferiority Trial of Streamlined Genetic Education and Testing for High-grade Epithelial Ovarian, Fallopian and Peritoneal Cancer Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Ovarian Cancer, Epithelial
• Peritoneal Cancer
• Fallopian Tube Cancer

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2019-08-08
• Primary completion: 2021-07-31
• Completion: 2021-07-31
• First posted: 2020-09-03
• Last updated: 2021-08-26

Locations

1 site across 1 country: United States