NCT07682610

Brief Summary

This clinical trial studies statewide optimization of lung cancer screening (LCS) in Kentucky using the Quality Implementation of Lung Screening (QUILS™) System. Data from the Kentucky Cancer Registry shows that LCS implementation has contributed to a rapid decline in late-stage lung cancer diagnosis at twice the national average. Further, the declines are more than three times the national average decline in Kentucky's Central Appalachian region. Kentucky-based multilevel initiatives are needed to expand and accelerate this leading role and extend the LCS opportunity to more Kentuckians who are at increased risk of lung cancer. This trial may be able to accelerate optimal high-quality implementation of LCS utilizing the QUILS™ System and reduce the burden of lung cancer by assisting lung cancer screening programs located throughout Kentucky in implementing best practices in lung cancer screening by integrating the QUILS™ System domains and elements into their screening programs.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35,500

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Apr 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

17 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Apr 2025Jun 2028

Study Start

First participant enrolled

April 1, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 6, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

July 6, 2026

Status Verified

June 1, 2026

Enrollment Period

2.2 years

First QC Date

June 26, 2026

Last Update Submit

June 26, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Quality Improvement Lung Cancer Screening (QUILS) Index Assessment Score

    The QUILS Index Assessment is a program-level measure of lung cancer screening implementation quality. Scores range from 0 to 95, with a higher score indicating higher quality implementation of lung cancer screening practices. The outcome measure is the change in total QUILS Index score from Baseline to 12 months.

    Baseline and Month 9

Study Arms (1)

QUILS System Implementation

EXPERIMENTAL

Participants who are members of the lung cancer screening program (LCSP) team will receive the QUILS System intervention, including completion of the QUILS Index Assessment, participation in QUILS Audit and Feedback presentations, access tot the QUILS Resource Portal and site specific action plans, and formative evaluation interviews.

Behavioral: Quality Implementation of Lung Cancer Screening (QUILS) System

Interventions

The QUILS System is a health services research intervention designed to improve the quality of lung cancer screening programs. The intervention includes QUILS Index Assessment, QUILS Audit and Feedback Report and Presentation, QUILS Resource Portal, site-specific action plans, and formative evaluation activities.

QUILS System Implementation

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Member of a participating Lung Cancer Screening Program (LCSP) team or administrator
  • Willing to participate in the QUILS Index Assessment Survey process
  • Willing to participate in the QUILS Audit Feedback presentations
  • Willing to participate in formative evaluation interviews

You may not qualify if:

  • Unwilling to participate in the QUILS Index Assessment Survey process
  • Unwilling to participate in the QUILS Audit Feedback presentations
  • Unwilling to participate in formative evaluation interviews

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

King's Daughter's Medical Center

Ashland, Kentucky, 41101, United States

RECRUITING

Taylor Regional Hospital

Campbellsville, Kentucky, 42718, United States

RECRUITING

St. Elizabeth Healthcare

Edgewood, Kentucky, 41017, United States

RECRUITING

Georgetown Cancer Treatment Cancer

Georgetown, Kentucky, 40324, United States

RECRUITING

TJ Samson Community Hospital

Glasgow, Kentucky, 42141, United States

RECRUITING

Hazard Appalachian Regional Healthcare Medical Center

Hazard, Kentucky, 41701, United States

RECRUITING

Lexington VA Health Care System

Lexington, Kentucky, 40502, United States

RECRUITING

St. Joseph Health (Catholic Health Initiatives)

Lexington, Kentucky, 40504, United States

RECRUITING

University of Kentucky Markey Cancer Center

Lexington, Kentucky, 40506, United States

RECRUITING

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

Meadowview Regional Medical Center

Maysville, Kentucky, 41056, United States

RECRUITING

Saint Claire Regional Medical Center

Morehead, Kentucky, 40351, United States

RECRUITING

Rockcastle Regional Hospital

Mount Vernon, Kentucky, 40456, United States

RECRUITING

Owensboro Health Mitchell Memorial Cancer Center

Owensboro, Kentucky, 42303, United States

RECRUITING

Mercy Health - Paducah Cancer Center

Paducah, Kentucky, 42003, United States

RECRUITING

Lake Cumberland Regional Hospital

Somerset, Kentucky, 42501, United States

RECRUITING

Clark Regional Medical Center

Winchester, Kentucky, 40391, United States

RECRUITING

MeSH Terms

Interventions

Drug Delivery Systems

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Central Study Contacts

Joseph Alexander, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 26, 2026

First Posted

July 6, 2026

Study Start

April 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

July 6, 2026

Record last verified: 2026-06

Locations