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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 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: January 10, 2014
Last verified: January 2014
  Purpose

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 Intervention
Non-small Cell Lung Cancer
Other: communication intervention
Other: Real Time Registry and data feedback only

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Lung Cancer Surgery: Decisions Against Life Saving Care - The Intervention

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 496
Study Start Date: August 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01687738

Contacts
Contact: Samuel Cykert, MD 919-966-2461 samuel_cykert@med.unc.edu
Contact: Audrina J Bunton, MA 9198433084 audrina_bunton@unc.edu

Locations
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    samuel_cykert@med.unc.edu   
Contact: Audrina J Bunton, MA    919-843-3084    audrina_bunton@unc.edu   
Principal Investigator: Paul Walker, MD         
Principal Investigator: Franklin McGuire, MD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
East Carolina University
University of South Carolina
Investigators
Principal Investigator: Samuel Cykert, MD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Samuel Cykert, MD, Professor of Medicine and Associate Director, Medical Education, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01687738     History of Changes
Other Study ID Numbers: 11-0992, 121218-RSG-05-217-05-CPPB
Study First Received: September 11, 2012
Last Updated: January 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
non small cell lung cancer
health disparities

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 24, 2014