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


N/A
21 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Number of patients with stage I and II, non-small cell lung cancer who receive surgery.

Outcome Description:

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.

Outcome Time Frame:

Baseline to 4 months

Safety Issue:

No

Principal Investigator

Samuel Cykert, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina, Chapel Hill

Authority:

United States: Institutional Review Board

Study ID:

11-0992

NCT ID:

NCT01687738

Start Date:

August 2012

Completion Date:

June 2016

Related Keywords:

  • Non-Small Cell Lung Cancer
  • non small cell lung cancer
  • health disparities
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
The University Of North Carolina At Chapel Hill Chapel Hill, North Carolina  27599-7235