Clinical trial NCT04537702: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cancer, Epithelial
Peritoneal Cancer
Fallopian Tube Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-09-03
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Following consent, the clinical research coordinator will randomize the patient to either the Traditional Group (TG) or Streamlined Group (SG). The randomization process will have occurred previously using blocks of ten randomly computer-generated numbers. These numbers will be kept in individual, ordered envelopes. When a subject requires randomization, the next envelope in the sequence will be opened and the subject will be randomized according to the number listed in the envelope.
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Demographic Information
timeFrame: Baseline
measure: Numeracy assessment
timeFrame: Baseline
measure: Electronic Family History
timeFrame: Completed at least 1 week prior to genetic sample being taken
measure: Change in anxiety and depression as measured by the IES Scale
timeFrame: Baseline, approximately 7 days post-education, and approximately 7 days post-results disclosure
measure: Distress as measured by MICRA
timeFrame: Approximately 7 days post-results disclosure
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke Health
name: Rebecca Previs, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: