Brief Title
Prospective Randomized Trial of Streamlined Genetic Education and Testing for Ovarian Cancer Patients
Official Title
Prospective, Randomized Non-inferiority Trial of Streamlined Genetic Education and Testing for High-grade Epithelial Ovarian, Fallopian and Peritoneal Cancer Patients
Brief 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.
Study Type
Interventional
Primary Outcome
Demographic Information
Condition
Ovarian Cancer, Epithelial
Intervention
Streamlined Education
Study Arms / Comparison Groups
Tradition Counseling Group (TG)
Description: After completion of baseline surveys, the TG subjects will be referred to a formal pre-test consultation with a genetic counselor. TG subjects will complete an electronic family history questionnaire (FHQ) within one week of the primary visit. A member of the genetics team will curate the results by contacting the subject to review errors and clarify any ambiguities in the pedigree. The TG subjects will then meet with the genetic counselor. After counseling, participants will be given the option to undergo a multi-gene panel genetic test. Those who agree to testing will also complete the standard genetic testing consent form. As per standard practice, patients will also be asked to provide consent for somatic tumor testing of surgical (non-cytologic) specimen. Subjects will complete a post-education distress and anxiety survey (IES) either via an email link to a confidential REDCap survey link 1-2 weeks after formal consultation.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
112
Start Date
August 8, 2019
Completion Date
May 31, 2021
Primary Completion Date
May 31, 2021
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Rebecca Previs, MD, MS, 7322840917, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04537702
Organization ID
PRO00100538
Responsible Party
Sponsor
Study Sponsor
Duke University
Study Sponsor
Rebecca Previs, MD, MS, Principal Investigator, Duke University Health System
Verification Date
July 2020