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

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

Start Date

August 8, 2019

Completion Date

July 31, 2021

Primary Completion Date

July 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 Health

Verification Date

July 2021