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NCT02312817 · ClinicalTrials.gov registry record · NA
RCT of Screening Strategies Among Patients at High Risk for Developing HCC in a Safety-net Health System
A NA study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 1,800
- Enrollment target
NCT02312817 is a NA study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 1,800 participants.
The verdict
NCT02312817, a NA study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,800 participants
- Enrollment target
Study Summary
Hepatocellular carcinoma (HCC) is the 9th leading cause of cancer-related death in the US and one of the leading causes of death in patients with cirrhosis. Fewer than 1 in 5 high-risk patients undergo HCC screening, with lower rates in non-Caucasian and low socioeconomic status patients receiving care through safety-net health systems. Screening and follow-up failures lead to more advanced cancers, when curative therapies are not available and survival is significantly worse. Over 60% of HCC are diagnosed at advanced stages, due to poor recognition of high-risk patients, underuse of screening among these patients, and poor follow-up of abnormal screening tests. To address these barriers, the investigators propose to conduct a comparative effectiveness research randomized controlled trial of three screening strategies among a socioeconomically disadvantaged and racially diverse cohort of cirrhotic patients at high risk for developing HCC. Overall, 1800 patients attending Parkland, the Dallas safety-net health system, will be randomized to: * Group 1: Usual care, with visit-based HCC screening per discretion of individual providers * Group 2: Mailed HCC screening invitation outreach to eligible patients (low resource intensity) * Group 3: Mailed HCC screening invitation outreach to eligible patients combined with centralized patient navigation to promote screening completion and follow-up (high resource intensity) Through three specific aims, this effectiveness research randomized controlled trial will: * Aim 1: Engage stakeholders in design and implementation of HCC screening outreach interventions. * Aim 2: Compare the clinical effectiveness and patient acceptability of the intervention strategies to increase completion of one-time and repeat HCC screening. * Aim 3: Evaluate whether intervention effects are moderated by patient sex, race, ethnicity, English proficiency, and connectedness to primary care. The screening intervention strategies combine EMR-enable
Interventions
- OTHER Mailed Outreach Invitation
- OTHER Mailed Outreach Invitation and Patient Navigation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,800 participants |
| Start Date | 2014-12 |
| Est. Completion | 2017-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02312817
The ClinicalTrials.gov registry entry for NCT02312817 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1,800 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Mailed Outreach Invitation is the first listed.
NCT02312817 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02312817 about?
NCT02312817 is a clinical study titled "RCT of Screening Strategies Among Patients at High Risk for Developing HCC in a Safety-net Health System". Hepatocellular carcinoma (HCC) is the 9th leading cause of cancer-related death in the US and one of the leading causes of death in patients with cirrhosis. Fewer than 1 in 5 high-risk patients undergo HCC screening, with lower rates in non-Caucasian and low socioeconomic status patients receiving c...
What is the current status of trial NCT02312817?
This trial is currently completed. It is a NA study. The enrollment target is 1,800 participants. The study started on 2014-12. Estimated completion is 2017-08.
What interventions are being tested in trial NCT02312817?
The interventions under investigation include: Mailed Outreach Invitation (OTHER), Mailed Outreach Invitation and Patient Navigation (OTHER).
Who is sponsoring clinical trial NCT02312817?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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