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LDCT: Rural Illinois Lung Cancer Screening Initiative

Sponsor
Southern Illinois University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06084078
Collaborator
(none)
10,000
Enrollment
72
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    10000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Patient Identification, Prescreening and LDCT Screening for Lung Cancer With Telehealth
    Anticipated Study Start Date :
    Sep 1, 2024
    Anticipated Primary Completion Date :
    Aug 31, 2029
    Anticipated Study Completion Date :
    Aug 31, 2030

    Arms and Interventions

    Arm Intervention/Treatment
    Telehealth cohort

    Individuals who opt to do the screening using telehealth. Telehealth using video assisted techniques or using telephone.
    In-person cohort

    Individuals who are willing to travel to the hospital for in-person screening and follow-up

    Outcome Measures

    Primary Outcome Measures

    1. Screening rate [Through study completion, an average of 1 year]

      Percentage of individuals screened (completed CT imaging) with and without telehealth

    2. Early stage diagnosis [Through study completion, an average of 1 year]

      Percentage of individuals diagnosed with lung cancer at an early stage of the disease

    Secondary Outcome Measures

    1. Time to treatment initiation [Through study completion, an average of 1 year]

      Number of days from diagnosis to treatment initiation will be calculated for each patient diagnosed with lung cancer

    2. Adherence to Screening [Through study completion, an average of 1 year]

      Percentage of of individuals undergoing yearly screening with and without telehealth

    3. Cost [Through study completion, an average of 1 year]

      Overall cost from pre-screening to screening and follow-up with and without telehealth

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 80 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Southern Illinois University

    Investigators

    • Principal Investigator: Sowmy Thuppal, MD PhD, Southrn Illinois University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Southern Illinois University
    ClinicalTrials.gov Identifier:
    NCT06084078
    Other Study ID Numbers:
    • LDCT Screening
    First Posted:
    Oct 16, 2023
    Last Update Posted:
    Oct 16, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Southern Illinois University
    cancer screening
    LDCT
    Lung cancer
    Additional relevant MeSH terms:
    Lung Neoplasms

    Study Results

    No Results Posted as of Oct 16, 2023