Clinical trial NCT06084078: Rural Illinois Lung Cancer Screening Initiative
Official title: Patient Identification, Prescreening and LDCT Screening for Lung Cancer With Telehealth
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lung Cancer
Keywords: cancer screening
LDCT
Lung cancer
Lead sponsor: Southern Illinois University
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 10000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The risk of lung cancer increases with age and smoking status and hence this age range is recommended for receiving lung cancer screening. As per USPSTF criteria our screening initiative will include individuals 50-80 years, subjects of all sex/gender and all race/ethnic groups. Screening eligible individuals included in our pilot study consisted of 54.4 % women, 75% of non-Hispanic whites, 24% non-Hispanic blacks and 1.2% belonged to 'other' race category. Non-Hispanic black individuals with smoking history have a higher risk of developing lung cancer than a non-Hispanic white. Very few Hispanic persons and women tend to accumulate fewer pack-years over a long period of time.

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.

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.

Primary outcomes:
measure: Screening rate
timeFrame: Through study completion, an average of 1 year
measure: Early stage diagnosis
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Time to treatment initiation
timeFrame: Through study completion, an average of 1 year
measure: Adherence to Screening
timeFrame: Through study completion, an average of 1 year
measure: Cost
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Southrn Illinois University School of Medicine
name: Sowmy Thuppal, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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: 10.1370/afm.2905.
citation: 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.