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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04940221
Other study ID # 603913
Secondary ID U54GM104941
Status Completed
Phase N/A
First received
Last updated
Start date July 18, 2018
Est. completion date October 30, 2020

Study information

Verified date September 2023
Source Christiana Care Health Services
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Lung cancer screening rates are very low despite the fact that lung cancer screening could save many lives. People need to understand the risks and benefits to screening as well as their own beliefs about screening. This study builds an intervention in real world primary care that will help people make the right decision for them as well as help people to quit smoking. Interventions like this are needed to improve the screening rate and reduce death from lung cancer, which is the leading cancer killer.


Description:

Lung cancer screening rates in the United States are very low- just 3.3% in 2010 and 3.9% in 2015. There is a critical need to develop and implement effective strategies to engage high-risk patients in a coordinated program of lung cancer screening, which includes shared-decision making. The investigators proposed to modify and expand a shared decision- counseling intervention previously developed in one primary care practice. The investigators measured lung cancer screening in our intervention group compared to a propensity-matched usual care cohort. The investigators compared patients recruited to patients who are not in order to identify potential sources of disparity in future work and the investigators developed a more intense smoking cessation component. Model interventions for shared-decision making in clinical practice are needed across a wide range of diseases and decisions.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date October 30, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years to 78 Years
Eligibility Inclusion Criteria: - Current or former smoker - Greater than or equal to 30 pack years smoking Exclusion Criteria: - Prior CT in last year - Quit smoking greater than 15 years ago - Current diagnosis of lung cancer

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Shared Decision Making
Telephone delivered non-persuasive shared decision-making for lung cancer screening.

Locations

Country Name City State
United States Christiana Care Health System Newark Delaware

Sponsors (4)

Lead Sponsor Collaborator
Christiana Care Health Services National Institute of General Medical Sciences (NIGMS), Thomas Jefferson University, University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Patients Who Received a Low Dose CT Scan of the Chest Percentage of individuals who have evidence of a low-dose CT scan of the chest in their electronic medical record at 1 year post intervention, as ascertained by chart audit by research assistance. 1 year
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