Lung Cancer Surgery: Decisions Against Life Saving Care - The Intervention
Conditions
Non-small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
non small cell lung cancer, health disparities
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Intervention
Name: communication intervention Type: Other
Name: Real Time Registry and data feedback only Type: Other
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 21 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Age 21 years or greater;

2. A probability of 60% or higher of a lung lesion being malignant as calculated by a Bayesian algorithm using clinical and radiographic characteristics or biopsy proven disease; and

3. The patient has been clinically classified as having stage I or II disease.

Exclusion Criteria:

1. incarceration / ward of the state status,

2. Severe cognitive impairment. If a patient meets the inclusion criteria but is consistently unable to comprehend survey questions during the interview process, we will exclude that patient from the overall study.

3. absolute contraindications by pulmonary function testing (FEV-1 < 25% of predicted)

4. Non-English speaking. Hispanic patients represent less than 4 percent of lung cancer patients in North Carolina restricting our ability to document an intervention effect.
Location
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Status: Recruiting
Contact: Samuel Cykert, MD - 919-966-2461 - samuel_cykert@med.unc.edu
Start Date
August 2012
Completion Date
June 2016
Sponsors
University of North Carolina, Chapel Hill
Source
University of North Carolina, Chapel Hill
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page