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NCT01687738 · ClinicalTrials.gov registry record · NA

Lung Cancer Surgery: Decisions Against Life Saving Care - The Intervention

A NA study of Non-Small Cell Lung Cancer, sponsored by University of North Carolina, Chapel Hill.

Completed
Registry status
NA
Development phase
238
Enrollment target
1
Study location

NCT01687738 is a NA study of Non-Small Cell Lung Cancer that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 238 participants, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01687738, a NA study of Non-Small Cell Lung Cancer, has completed, sponsored by University of North Carolina, Chapel Hill.

COMPLETED
Registry status
NA
Development phase
238 participants
Enrollment target
1
Study location

Study Summary

Purpose: Overall lung surgery rates and black/white disparities have not improved during a decade of documentation. The goal of this study is to incorporate lessons from the previous prospective cohort study to optimize lung cancer surgery rates and narrow black-white disparities for patients diagnosed with stage I or II, non-small cell lung cancer. Participants: Stage I and II, non-small cell lung cancer at 3 participating sites. Procedures: Phase I of the study has been completed. Phase I was a deidentified 3-year, retrospective chart review, used to establish the baseline surgical rates for the intervention. The patient enrollment phase of the study will move forward that will include use of a real time registry to follow patient progression through clinical follow up, diagnostic testing and treatment for biopsy proven or highly probable early stage, non-small cell lung cancer. The patient enrollment portion of the study will start, September 2012. All patients with Stage I or II non-small cell lung cancer who enroll in the study will be entered into real time registries at every site. Patients' progress through the registries including follow-up provider visits, diagnostic tests, and procedures will be transparent and any missed appointments will be flagged. Feedback will be given to lung cancer providers in both arms. The randomized trial will compare patients who receive usual care plus the registry to those who receive the registry plus visits and calls from a trained cancer communicator -educator (CCE) who is well versed in issues specific to lung cancer and trained in active listening and communication that accounts for patients' limitations in health literacy. The CCE will also use Kleinman's Patient Model to identify attitudes or beliefs that represent barriers to recommended care that could potentially be addressed through negotiation and more targeted communication. The hypothesis is that an electronic warning system, data transparency, and enhanced c

Conditions Studied

Interventions

  • OTHER communication intervention
  • OTHER Real Time Registry and data feedback only

Study Locations (1)

North Carolina

  • The University of North Carolina at Chapel Hill - Chapel Hill

Trial Details

FieldValue
Enrollment Target 238 participants
Start Date 2012-08
Est. Completion 2017-06-30
Phase NA

What the Registry Record Tells You About NCT01687738

The ClinicalTrials.gov registry entry for NCT01687738 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 238 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (64% lower). The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which communication intervention is the first listed.

NCT01687738 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT01687738 about?

NCT01687738 is a clinical study titled "Lung Cancer Surgery: Decisions Against Life Saving Care - The Intervention". Purpose: Overall lung surgery rates and black/white disparities have not improved during a decade of documentation. The goal of this study is to incorporate lessons from the previous prospective cohort study to optimize lung cancer surgery rates and narrow black-white disparities for patients diagno...

What is the current status of trial NCT01687738?

This trial is currently completed. It is a NA study. The enrollment target is 238 participants. The study started on 2012-08. Estimated completion is 2017-06-30.

What conditions does trial NCT01687738 study?

This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.

What interventions are being tested in trial NCT01687738?

The interventions under investigation include: communication intervention (OTHER), Real Time Registry and data feedback only (OTHER).

Who is sponsoring clinical trial NCT01687738?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01687738 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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