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 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.
|Non-small Cell Lung Cancer||Other: communication intervention Other: Real Time Registry and data feedback only|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
|Official Title:||Lung Cancer Surgery: Decisions Against Life Saving Care - The 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.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687738
|Contact: Samuel Cykert, MDemail@example.com|
|Contact: Audrina J Bunton, MAfirstname.lastname@example.org|
|United States, North Carolina|
|The University of North Carolina at Chapel Hill||Recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: Samuel Cykert, MD 919-966-2461 email@example.com|
|Contact: Audrina J Bunton, MA 919-843-3084 firstname.lastname@example.org|
|Principal Investigator: Paul Walker, MD|
|Principal Investigator: Franklin McGuire, MD|
|Principal Investigator:||Samuel Cykert, MD||University of North Carolina, Chapel Hill|