Lung Cancer Surgery: Decisions Against Life Saving Care - The Intervention
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|ClinicalTrials.gov Identifier: NCT01687738|
Recruitment Status : Completed
First Posted : September 19, 2012
Last Update Posted : October 13, 2017
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 communication will optimize lung surgery rates and reduce racial gaps.
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Other: communication intervention Other: Real Time Registry and data feedback only||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||238 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Lung Cancer Surgery: Decisions Against Life Saving Care - The Intervention|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||June 30, 2017|
|Actual Study Completion Date :||June 30, 2017|
Experimental: Communication Intervention
Specially trained communicator addresses factual understanding and elicits other barriers to care
Other: communication intervention
Because of the gaps between documented outcomes of lung cancer surgery and patient communication barriers identified in our recent work, our communication intervention will focus on improving presentation of risk information and confirmation of understanding of patient medical.
Experimental: Real Time Registry and data feedback only
Patients are enrolled in registry and clinicians receive warnings about delayed or missed care.
Other: Real Time Registry and data feedback only
This group of patients will not received the enhanced communication intervention
- Number of patients with stage I and II, non-small cell lung cancer who receive surgery. [ Time Frame: Baseline to 4 months ]The primary outcome variable, surgery yes or no, will be compared in the control group randomized to usual care, to the intervention group randomized to the cancer communicator.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01687738
|United States, North Carolina|
|The University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Samuel Cykert, MD||University of North Carolina, Chapel Hill|