Rural Illinois Lung Cancer Screening Initiative

Lung Cancer Clinical Trial

— LDCT  

Official title:

Patient Identification, Prescreening and LDCT Screening for Lung Cancer With Telehealth

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06084078
• Other study ID #: LDCT Screening
• Status: Not yet recruiting
• Start date: September 1, 2024
• Est. completion date: August 31, 2030

Study information

• Verified date: October 2023
• Source: Southern Illinois University
• Contact: Sowmy Thuppal, MD PhD
• Phone: 217-545-2320
• Email: sthuppal83[@]siumed.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The role of this observational study is to access the feasibility of providing lung cancer screening using a designated nurse navigator through lung cancer screening clinic. Eligible participants will be identified using medical records, eligibility will be confirmed through phone call, screening visits will be scheduled as in-person visit or telehealth visit. Computed tomography screening will be performed at an approved center closer to the individuals place of living and results will be discussed during follow-up in-person visit or telehealth visit.

Description:

The long-term goal is to establish healthcare practices to increase adherence to lung cancer screening among high-risk individuals. The overall objective in this application is to establish a lung cancer screening initiative to proactively identify and screen eligible patients for LDCT using a designated nurse practitioner (NP) along with telehealth. The central hypothesis is that use of a designated NP along with telehealth will increase lung cancer screening via LDCT among high-risk, racial/ethnic minority, and rural/sub-urban patients. The rationale for this proposal is use of a NP and telehealth will help overcome the barriers physicians face in identifying eligible patients for LDCT including collecting additional information to determine eligibility, discussing the pros and cons of LDCT, providing smoking cessation/abstinence counseling, making shared decisions, and documenting this information in the patients' charts.

In this prospective cohort study the nurse practitioner (NP) will proactively identify eligible individuals for LDCT using EMRs that are shared across the Department of Family and Community Medicine at SIU. These patients will be contacted and those agreeing to undergo screening will be given a referral to a nearby LDCT center. The NP will follow-up with the patients with the results of the LDCT and will refer them for further management to their primary care physician. If the results are negative for nodules then they will be followed up on a yearly basis until the participants are older than 80 years or have other life-threatening health issues.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: August 31, 2030
• Est. primary completion date: August 31, 2029
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• All individuals 50-80 years of age

• 20 pack-year smoking history

• Currently smoke or have quit within the past 15 years:

Exclusion Criteria:

• Individuals 49 years and below or 81 years and above

• Has not smoked in 15 or more years

• Individuals who develop a health problem that makes them unwilling or unable to have surgery if lung cancer is detected.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Southern Illinois University

References & Publications (2)

National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4; — View Citation

Thuppal S, Hendren JR, Colle J, Sapra A, Bhandari P, Rahman R, Krus-Johnston A, Hoffman MR, Foray N, Hazelrigg S, Crabtree T. Proactive Recruitment Strategy for Patient Identification for Lung Cancer Screening. Ann Fam Med. 2023 Mar-Apr;21(2):119-124. doi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Screening rate	Percentage of individuals screened (completed CT imaging) with and without telehealth	Through study completion, an average of 1 year
Primary	Early stage diagnosis	Percentage of individuals diagnosed with lung cancer at an early stage of the disease	Through study completion, an average of 1 year
Secondary	Time to treatment initiation	Number of days from diagnosis to treatment initiation will be calculated for each patient diagnosed with lung cancer	Through study completion, an average of 1 year
Secondary	Adherence to Screening	Percentage of of individuals undergoing yearly screening with and without telehealth	Through study completion, an average of 1 year
Secondary	Cost	Overall cost from pre-screening to screening and follow-up with and without telehealth	Through study completion, an average of 1 year