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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of North Carolina, Chapel Hill
Sponsor:
Collaborators:
East Carolina University
University of South Carolina
Information provided by (Responsible Party):
Samuel Cykert, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01687738
First received: September 11, 2012
Last updated: August 4, 2014
Last verified: August 2014

September 11, 2012
August 4, 2014
August 2012
June 2015   (final data collection date for primary outcome measure)
Number of patients with stage I and II, non-small cell lung cancer who receive surgery. [ Time Frame: Baseline to 4 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01687738 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Lung Cancer Surgery: Decisions Against Life Saving Care - The Intervention
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Non-small Cell Lung Cancer
  • 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.
  • Other: Real Time Registry and data feedback only
    This group of patients will not received the enhanced communication intervention
  • Experimental: Communication Intervention
    Specially trained communicator addresses factual understanding and elicits other barriers to care
    Intervention: Other: communication intervention
  • Experimental: Real Time Registry and data feedback only
    Patients are enrolled in registry and clinicians receive warnings about delayed or missed care.
    Intervention: Other: Real Time Registry and data feedback only
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
496
June 2016
June 2015   (final data collection date for primary outcome measure)

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.
Both
21 Years and older
No
Contact: Samuel Cykert, MD 919-966-2461 samuel_cykert@med.unc.edu
Contact: Audrina J Bunton, MA 9198433084 audrina_bunton@unc.edu
United States
 
NCT01687738
11-0992, 121218-RSG-05-217-05-CPPB
No
Samuel Cykert, MD, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
  • East Carolina University
  • University of South Carolina
Principal Investigator: Samuel Cykert, MD University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP