Lung Cancer ScreeningNCT07682610
Kentucky - Quality Improvement Implementation Lung Cancer Screening (QUILS™) Health Services Research Intervention
A study testing Quality Implementation of Lung Cancer Screening (QUILS) System in people with Lung Cancer Screening, run by Timothy Mullett at 17 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer Screening
- What is being tested?
- Quality Implementation of Lung Cancer Screening (QUILS) System
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35,500 participants
- Where
- 17 sitesUnited States
- Study dates
- 1 Apr 2025to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
United States17 sites, 17 recruiting
- Recruiting
King's Daughter's Medical Center
Ashland, Kentucky, 41101
Joseph Alexander, 8593230892, joseph.alexander@uky.edu
- Recruiting
Taylor Regional Hospital
Campbellsville, Kentucky, 42718
Joseph Alexander, 8593230892, joseph.alexander@uky.edu
- Recruiting
St. Elizabeth Healthcare
Edgewood, Kentucky, 41017
Joseph Alexander, 8593230892, joseph.alexander@uky.edu
- Recruiting
Georgetown Cancer Treatment Cancer
Georgetown, Kentucky, 40324
Joseph Alexander, 859-323-0892, joseph.alexander@uky.edu
- Recruiting
TJ Samson Community Hospital
Glasgow, Kentucky, 42141
Joseph Alexander, 8593230892, joseph.alexander@uky.edu
- Recruiting
Hazard Appalachian Regional Healthcare Medical Center
Hazard, Kentucky, 41701
Joseph Alexander, 8593230892, joseph.alexander@uky.edu
- Recruiting
Lexington VA Health Care System
Lexington, Kentucky, 40502
Joseph Alexander, 8593230892, joseph.alexander@uky.edu
- Recruiting
St. Joseph Health (Catholic Health Initiatives)
Lexington, Kentucky, 40504
Joseph Alexander, 8593230892, joseph.alexander@uky.edu
- Recruiting
University of Kentucky Markey Cancer Center
Lexington, Kentucky, 40506
jill.cole1@uky.edu
- Recruiting
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202
Joseph Alexander, 8593230892, joseph.alexander@uky.edu
- Recruiting
Meadowview Regional Medical Center
Maysville, Kentucky, 41056
Joseph Alexander, 8593230892, joseph.alexander@uky.edu
- Recruiting
Saint Claire Regional Medical Center
Morehead, Kentucky, 40351
Joseph Alexander, 8593230892, joseph.alexander@uky.edu
- Recruiting
Rockcastle Regional Hospital
Mount Vernon, Kentucky, 40456
Joseph Alexander, 8593230892, joseph.alexander@uky.edu
- Recruiting
Owensboro Health Mitchell Memorial Cancer Center
Owensboro, Kentucky, 42303
Jospeh Alexander, 8593230892, joseph.alexander@uky.edu
- Recruiting
Mercy Health - Paducah Cancer Center
Paducah, Kentucky, 42003
Joseph Alexander, 8593230892, joseph.alexander@uky.edu
- Recruiting
Lake Cumberland Regional Hospital
Somerset, Kentucky, 42501
Joseph Alexander, 8593230892, joseph.alexander@uky.edu
- Recruiting
Clark Regional Medical Center
Winchester, Kentucky, 40391
Joseph Alexander, 859-323-0892, joseph.alexander@uky.edu
About this study
Official title: Statewide Optimization of Lung Cancer Screening Utilizing the QUILS™ System (Kentucky QUILS™ Implementation): HSR Intervention
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.
- Conditions
- Lung Cancer Screening
- Being tested
- Quality Implementation of Lung Cancer Screening (QUILS) System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality Implementation of Lung Cancer Screening (QUILS) SystemBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Quality Implementation of Lung Cancer Screening (QUILS) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Apr 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Timothy Mullett
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Timothy Mullett, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682610
- Sponsor's protocol ID
- MCC-25-KQUILS-PT
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statewide Optimization of Lung Cancer Screening Utilizing the QUILS™ System (Kentucky QUILS™ Implementation): HSR Intervention
- ClinicalTrials.gov ID
- NCT07682610
- Acronym / sponsor ID
- MCC-25-KQUILS-PT
- Conditions
- Lung Cancer Screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35,500 participants (estimated)
- Lead sponsor
- Timothy MullettUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QUILS System Implementation | Experimental | Behavioral: Quality Implementation of Lung Cancer Screening (QUILS) SystemParticipants 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality Implementation of Lung Cancer Screening (QUILS) SystemThe 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. | Behavioural | QUILS System Implementation |
Primary outcome
Change in Quality Improvement Lung Cancer Screening (QUILS) Index Assessment Score
Time frame: Baseline and Month 9
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality Implementation of Lung Cancer Screening (QUILS) System in people with Lung Cancer Screening, run by Timothy Mullett at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph Alexander, MD (8593230892, joseph.alexander@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality Improvement Lung Cancer Screening (QUILS) Index Assessment Score (time frame: Baseline and Month 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.