Lung Cancer Surgery: Decisions Against Life Saving Care - The Intervention
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 10/15/2017 |
| Start Date: | August 2012 |
| End Date: | June 30, 2017 |
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.
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.
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.
We found this trial at
1
site
Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Paul Walker, MD
Phone: 919-966-2461
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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