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Recruiting NCT06084078

Rural Illinois Lung Cancer Screening Initiative

Observational Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Lung Cancer. Basic parameters: 50 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed 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.

Primary outcome measures

  • Screening rate [Time frame: Through study completion, an average of 1 year]
  • Early stage diagnosis [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (3)
  • Time to treatment initiation [Time frame: Through study completion, an average of 1 year]
  • Adherence to Screening [Time frame: Through study completion, an average of 1 year]
  • Cost [Time frame: Through study completion, an average of 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Sowmy Thuppal — Springfield

Publications

  • 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: 10.1370/afm.2905. PMID 36973046
  • 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;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29. PMID 21714641

Identifiers

NCT: NCT06084078 · LDCT Screening

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗