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Spots Global Cancer Trial Database for Lung Cancer Surgery: Decisions Against Life Saving Care - The Intervention

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Trial Identification

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

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

Study ID: NCT01687738

Study Description

Brief 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 communication will optimize lung surgery rates and reduce racial gaps.

Detailed Description: Note that the registry intervention will be compared to historical controls obtained from the electronic chart review. The main outcome will be receipt of lung resection surgery and this outcome will be assessed controlling for age, race, education, income, perceptions of communication, co-morbid illnesses, and level of health literacy.

Eligibility

Minimum Age: 21 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

Contact Details

Name: Samuel Cykert, MD

Affiliation: University of North Carolina, Chapel Hill

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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