Non-small Cell Lung CancerNCT01687738
Lung Cancer Surgery: Decisions Against Life Saving Care - The Intervention
A study testing communication intervention and Real Time Registry and data feedback only in people with Non-small Cell Lung Cancer, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- communication intervention and Real Time Registry and data feedback only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- incarceration / ward of the state status,
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
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.
Read the 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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- communication intervention, Real Time Registry and data feedback only
- Keywords
- non small cell lung cancer, health disparities
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
communication interventionOther
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.
Real Time Registry and data feedback onlyOther
This group of patients will not received the enhanced communication intervention
| Study group | Role | What they receive |
|---|---|---|
| Communication Intervention | Experimental | Specially trained communicator addresses factual understanding and elicits other barriers to care Receives: 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. Receives: Other: Real Time Registry and data feedback only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startAug 2012
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- East Carolina University, University of South Carolina
- Responsible party
- Principal investigator, Samuel Cykert, MD, University of North Carolina, Chapel Hill
- Investigators
- Samuel Cykert, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687738
- Sponsor's protocol ID
- 11-0992
- Other IDs
- 121218-RSG-05-217-05-CPPB
- Status last verified
- Oct 2017
- First submitted
- 11 Sep 2012
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30714689
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Cancer Surgery: Decisions Against Life Saving Care - The Intervention
- ClinicalTrials.gov ID
- NCT01687738
- Acronym / sponsor ID
- 11-0992
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- non small cell lung cancer, health disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- East Carolina University, University of South Carolina
- Study start
- Aug 2012
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 19 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Communication Intervention | Experimental | Other: communication interventionSpecially trained communicator addresses factual understanding and elicits other barriers to care |
| Real Time Registry and data feedback only | Experimental | Other: Real Time Registry and data feedback onlyPatients are enrolled in registry and clinicians receive warnings about delayed or missed care. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- incarceration / ward of the state status,
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| communication interventionBecause 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. | Other | Communication Intervention |
| Real Time Registry and data feedback onlyThis group of patients will not received the enhanced communication intervention | Other | Real Time Registry and data feedback only |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
- Derived from this study: PubMed 30714689Cykert 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Cykert, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing communication intervention and Real Time Registry and data feedback only in people with Non-small Cell Lung Cancer, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with stage I and II, non-small cell lung cancer who receive surgery. (time frame: Baseline to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01687738, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2017.