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

October 11, 2017 updated by: Samuel Cykert, MD, University of North Carolina, Chapel Hill

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

238

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • The University of North Carolina at Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

University of South Carolina
East Carolina University

Investigators

  • Principal Investigator: Samuel Cykert, MD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

September 11, 2012

First Submitted That Met QC Criteria

September 13, 2012

First Posted (Estimate)

September 19, 2012

Study Record Updates

Last Update Posted (Actual)

October 13, 2017

Last Update Submitted That Met QC Criteria

October 11, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-0992
  • 121218-RSG-05-217-05-CPPB (Other Identifier: American Cancer Society)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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