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NCT Number: NCT04537702

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

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.

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Key information

Conditions

Ovarian Cancer, Epithelial Adnexal Diseases Carcinoma Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Cancer Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Peritoneal Cancer Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Health System

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Streamlined Education

Behavioral

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.

Traditional Education

Behavioral

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).

Primary outcomes

  1. Demographic Information

    Time frame: Baseline

    Number of participants with children

  2. Numeracy assessment

    Time frame: Baseline

    Numeracy as assessed by the Newest Vital Sign survey

  3. Electronic Family History

    Time frame: Completed at least 1 week prior to genetic sample being taken

    Family cancer history up to past 3 generations

  4. Change in anxiety and depression as measured by the IES Scale

    Time frame: 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."

  5. Distress as measured by MICRA

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 3, 2020
Registry last updated
Aug 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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