Lung CancerNCT06327074
Testing the Engaged Approach to Lung Cancer Screening
A study testing Engaged Approach to Lung Cancer Screening in people with Lung Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The goal of this study is to assess feasibility and acceptability of the Engaged Approach to Lung Cancer Screening (EA-LCS) in diverse lung cancer screening (LCS) programs operating in a variety of geographic regions across Colorado and the US. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Engaged Approach to Lung Cancer Screening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2024to Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The trial incorporates a multilevel assessment and enrollment involves inclusion criteria at two levels: (1) LCS Program and (2) LCS Program Staff member.
- Program inclusion criteria (n = up to 8 sites):
- Must conduct at least 50 low-dose computed tomography (LDCT) scans per year (baseline + follow-up)
- Must be able to identify a primary contact person for LCS program operations (e.g., program coordinator, program navigator, program manager, etc.)
- Staff member inclusion criteria (n ~ 5 at each site/~40 participants total):
- Identified staff member of the LCS program site
Show all 9Show fewer
- >18 years of age
- Must be able to complete study surveys and interviews in English
- Willing to provide informed consent
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Denver, Colorado, 80045
About this study
Official title: Feasibility Testing the Engaged Approach to Lung Cancer Screening
The goal of this study is to assess feasibility and acceptability of the Engaged Approach to Lung Cancer Screening (EA-LCS) in diverse lung cancer screening (LCS) programs operating in a variety of geographic regions across Colorado and the US.
- Conditions
- Lung Cancer
- Being tested
- Engaged Approach to Lung Cancer Screening
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engaged Approach to Lung Cancer ScreeningBehavioural
Also called EA-LCS
Sites randomized to use the EA-LCS materials will be given password-protected access to the program/toolkit web portal and encouraged to use any materials that fit the normal flow of clinic procedures. Materials available include both staff-facing and LCS candidate-facing materials.
Staff-facing materials include:
- Program website/manual/toolkit overview
- Implementation insights with experts video series
- Clinical placement placards
- Program and clinician communication tools
Candidate-facing materials include:
- Program welcome letter
- Maps and directions template
- Communication preferences
- Candidate letter templates (N=~8)
- Program newsletter template and instructions
- Lung nodule size comparison chart
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Sites in the control condition will be asked to complete appropriate/relevant surveys and interviews with minor modifications as needed and use the same Electronic Health Record Data Abstraction process. |
| Experimental Group | Experimental | Sites randomized to use the EA-LCS materials will be given password-protected access to the program/toolkit web portal and encouraged to use any materials that fit the normal flow of clinic procedures. Materials available include both staff-facing and LCS candidate-facing materials. Receives: Behavioral: Engaged Approach to Lung Cancer Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of the intervention group who would like to continue the EA-LCS framework
Measured: 7 months
Percentage of the intervention group who would recommend the EA-LCS framework to other programs
Measured: 7 months
Percentage of participants who would describe the framework as workable
Measured: 7 months
Secondary outcomes (3)
Evaluate the intervention acceptability by Acceptability of Intervention Measure (AIM)
Indexes of intervention acceptability will be measured by the Acceptability of Intervention Measure (AIM).
A 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean.
Measured: 12 months
Evaluate the intervention appropriateness by Intervention Appropriateness Measure (IAM)
Indexes of intervention appropriateness will be measured by the Intervention Appropriateness Measure (IAM).
A 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean.
Measured: 12 months
Evaluate the intervention feasibility by Feasibility of Intervention Measure (FIM)
Indexes of intervention feasibility will be measured by the Feasibility of Intervention Measure (FIM).
A 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start11 Mar 2024
- Primary completion30 Oct 2024
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Jamie Studts, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327074
- Sponsor's protocol ID
- 21-3063.cc
- Status last verified
- Dec 2025
- First submitted
- 6 Feb 2024
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Testing the Engaged Approach to Lung Cancer Screening
- ClinicalTrials.gov ID
- NCT06327074
- Acronym / sponsor ID
- 21-3063.cc
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Mar 2024 (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.
The goal of this study is to assess feasibility and acceptability of the Engaged Approach to Lung Cancer Screening (EA-LCS) in diverse lung cancer screening (LCS) programs operating in a variety of geographic regions across Colorado and the US.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Sites in the control condition will be asked to complete appropriate/relevant surveys and interviews with minor modifications as needed and use the same Electronic Health Record Data Abstraction process. |
| Experimental Group | Experimental | Behavioral: Engaged Approach to Lung Cancer ScreeningSites randomized to use the EA-LCS materials will be given password-protected access to the program/toolkit web portal and encouraged to use any materials that fit the normal flow of clinic procedures. Materials available include both staff-facing and LCS candidate-facing materials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The trial incorporates a multilevel assessment and enrollment involves inclusion criteria at two levels: (1) LCS Program and (2) LCS Program Staff member.
- Must conduct at least 50 low-dose computed tomography (LDCT) scans per year (baseline + follow-up)
- Must be able to identify a primary contact person for LCS program operations (e.g., program coordinator, program navigator, program manager, etc.)
- Identified staff member of the LCS program site
- >18 years of age
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Engaged Approach to Lung Cancer ScreeningAlso: EA-LCSSites randomized to use the EA-LCS materials will be given password-protected access to the program/toolkit web portal and encouraged to use any materials that fit the normal flow of clinic procedures. Materials available include both staff-facing and LCS candidate-facing materials. Staff-facing materials include: * Program website/manual/toolkit overview * Implementation insights with experts video series * Clinical placement placards * Program and clinician communication tools Candidate-facing materials include: * Program welcome letter * Maps and directions template * Communication preferences * Candidate letter templates (N=~8) * Program newsletter template and instructions * Lung nodule size comparison chart | Behavioural | Experimental Group |
Primary outcome
Percentage of the intervention group who would like to continue the EA-LCS framework
Time frame: 7 months
Percentage of the intervention group who would recommend the EA-LCS framework to other programs
Time frame: 7 months
Percentage of participants who would describe the framework as workable
Time frame: 7 months
3 secondary outcomes
Evaluate the intervention acceptability by Acceptability of Intervention Measure (AIM)
Time frame: 12 months
Evaluate the intervention appropriateness by Intervention Appropriateness Measure (IAM)
Time frame: 12 months
Evaluate the intervention feasibility by Feasibility of Intervention Measure (FIM)
Time frame: 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 22 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Lung Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2/3
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
RecruitingPhase 3
A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)
Non-small Cell Lung Cancer
Recruiting
More Than Just X-Rays - Imaging of Chemotherapy-induced Morphological and Functional Cardiovascular and Lung Changes After Childhood ALL and Other Cancers - a Monocentric Late Effects Study (MaximALL)
Acute Lymphatic Leukemia, Lymphoma
RecruitingPhase 1
SW-682 in Advanced Solid Tumors
Advanced Solid Tumor, Mesothelioma, Malignant
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. This study is not recruiting at the moment.
Jamie Studts, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Engaged Approach to Lung Cancer Screening in people with Lung Cancer, run by University of Colorado, Denver at 1 site 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 9 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of the intervention group who would like to continue the EA-LCS framework (time frame: 7 months). The study lists 3 primary outcomes in all. 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 22 Dec 2025.