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

NCT01687738 | Completed

• 2 other identifiers: 11-0992121218-RSG-05-217-05-CPPB
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer

Keywords

non small cell lung cancer; health disparities

Outcome Measures

Primary Outcomes (1)

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

  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

Study Arms (2)

Communication Intervention

EXPERIMENTAL

Specially trained communicator addresses factual understanding and elicits other barriers to care

Other: communication intervention

Real Time Registry and data feedback only

EXPERIMENTAL

Patients are enrolled in registry and clinicians receive warnings about delayed or missed care.

Other: Real Time Registry and data feedback only

Interventions

communication intervention OTHER

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.

Communication Intervention

Real Time Registry and data feedback only OTHER

This group of patients will not received the enhanced communication intervention

Real Time Registry and data feedback only

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21 years or greater;
• 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
• The patient has been clinically classified as having stage I or II disease.

You may not qualify if:

• incarceration / ward of the state status,
• absolute contraindications by pulmonary function testing (FEV-1 \< 25% of predicted)
• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• East Carolina University: collaborator
• University of South Carolina: collaborator

Study Sites (1)

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• Cykert S, Eng E, Walker P, Manning MA, Robertson LB, Arya R, Jones NS, Heron DE. A system-based intervention to reduce Black-White disparities in the treatment of early stage lung cancer: A pragmatic trial at five cancer centers. Cancer Med. 2019 Mar;8(3):1095-1102. doi: 10.1002/cam4.2005. Epub 2019 Feb 4.

  PMID: 30714689 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Samuel Cykert, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Associate Director, Medical Education

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: September 19, 2012
• Study Start: August 1, 2012
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: October 13, 2017

Record last verified: 2017-10

Locations

US (1)