Rural Illinois Lung Cancer Screening Initiative

NCT ID: NCT06084078

Last Updated: 2024-11-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2030-08-31

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.

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.

Conditions

Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Telehealth cohort

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

No interventions assigned to this group

In-person cohort

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

No interventions assigned to this group

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southern Illinois University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sowmy Thuppal, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Southrn Illinois University School of Medicine

Central Contacts

Sowmy Thuppal, MD PhD

Role: CONTACT

sthuppal83@siumed.edu

217-545-2320

References

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.

Reference Type: RESULT

PMID: 36973046 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21714641 (View on PubMed)

Other Identifiers

LDCT Screening

Identifier Type: -

Identifier Source: org_study_id