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

Not Applicable

Completed

• Conditions: Fallopian Tube Cancer; Peritoneal Cancer; Ovarian Cancer, Epithelial
• Interventions: Behavioral: Traditional Education; Behavioral: Streamlined Education

• Registration Number: NCT04537702
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-08-08
• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-08-31
• Study First Posted: 2020-09-03
• Status Verified: 2021-07
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tradition Counseling Group (TG)	Traditional Education	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.
Streamlined Group (SG)	Streamlined Education	After completion of the baseline surveys, the SG subjects will watch an approximately eight minute long genetics education video. All subjects will then have the option to "opt out" and receive formal genetic counseling prior to making a decision about testing. If the subject elects to undergo genetic testing, she will fill out the standard genetic testing consent form. As per standard practice of the clinical genetic service at Duke Cancer Institute (DCI), patients will also be asked to provide consent for somatic tumor testing of surgical (non-cytologic) specimen. SG subjects will complete an FHQ within one week of the primary visit. A member of the genetics team will curate the results by contacting the subject to review common errors and clarify any ambiguities in the pedigree. Subjects will complete a post-education distress and anxiety survey (IES) via either an email link to a confidential REDCap survey link or over the phone 1-2 weeks after education.

Primary Outcome Measures

Name	Time	Method
Numeracy assessment	Baseline	Numeracy as assessed by the Newest Vital Sign survey
Electronic Family History	Completed at least 1 week prior to genetic sample being taken	Family cancer history up to past 3 generations
Demographic Information	Baseline	Number of participants with children
Distress as measured by MICRA	Approximately 7 days post-results disclosure	The multidimensional impact of cancer risk assessment questionnaire (MICRA) is a 25-question validated tool that measures the impact of result disclosure in patients, particularly markers of distress
Change in anxiety and depression as measured by the IES Scale	Baseline, approximately 7 days post-education, and approximately 7 days post-results disclosure	The Impact of Events Scale (IES) has been used widely as a means of measuring patient distress (particularly intrusive thoughts or avoidance) over a defined incident. This evaluation will be used to identify trends in anxiety or depression in both arms throughout the education and testing process. In this trial, the "incident" will be described as "the risk of my cancer being hereditary."

Trial Locations

Locations (1)

Duke University Health System; 🇺🇸 Durham, North Carolina, United States