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NCT04537702 · ClinicalTrials.gov registry record · NA
Prospective Randomized Trial of Streamlined Genetic Education and Testing for Ovarian Cancer Patients
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 64
- Enrollment target
NCT04537702 is a NA study that has completed, run by Duke University. The registered enrollment target is 64 participants.
The verdict
NCT04537702, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 64 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Traditional Education
- BEHAVIORAL Streamlined Education
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2019-08-08 |
| Est. Completion | 2021-07-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04537702
The ClinicalTrials.gov registry entry for NCT04537702 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Traditional Education is the first listed.
NCT04537702 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04537702 about?
NCT04537702 is a clinical study titled "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 r...
What is the current status of trial NCT04537702?
This trial is currently completed. It is a NA study. The enrollment target is 64 participants. The study started on 2019-08-08. Estimated completion is 2021-07-31.
What interventions are being tested in trial NCT04537702?
The interventions under investigation include: Traditional Education (BEHAVIORAL), Streamlined Education (BEHAVIORAL).
Who is sponsoring clinical trial NCT04537702?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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