Lung CarcinomaNCT06324110
Evaluating the Impact of Centralized Interventions on Lung Cancer Screening Adherence in Community Settings, ACCELL Trial
A study testing Electronic Health Record Review, Interview and Patient Navigation in people with Lung Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This clinical trial tests the impact of lung cancer screening care coordination interventions implemented at the system-level on lung cancer screening adherence in community settings. Lung cancer remains the leading cause of cancer death in the United States. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Carcinoma
- What is being tested?
- Electronic Health Record Review, Interview and Patient Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,772 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to 31 Oct 2027
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- AIM II: Age 50-80
- AIM II: Current or former (within 15 years) smoker
- AIM II: 20+ pack-years of cigarette use
- AIM II: Undergone at least one lung cancer screening low-dose chest computed tomography (CT) at partnering sites within the study period
- AIM III (PROVIDER INTERVIEWS): Age minimum of 18
- AIM III (PROVIDER INTERVIEWS): Affiliation with Skagit Regional Health System, Confluence Health or Kadlec Regional Medical Center
Show all 16Show fewer
- AIM III (PROVIDER INTERVIEWS): Identifies as providing primary care or specialty care to LCS patients (medical doctor [MD], registered nurse [RN], physician assistant [PA], advanced registered nurse practitioner [ARNP])
- AIM III (LCS PATIENT INTERVIEWS): Aged 50-80 years
- AIM III (LCS PATIENT INTERVIEWS): Received lung cancer screening at Skagit Regional Health System, Confluence Health or Kadlec Regional Medical Center within the intervention period
- AIM III (LCS PATIENT INTERVIEWS): Was eligible for LCS at time of performance by United States Preventative Services Taskforce (USPSTF) criteria
- Age 50-80 at time of exam
- At least 20 pack-year smoking history
- Currently smoking or smoked within the last 15 years
- AIM III (LCS-SPECIFIC CARE COORDINATORS): Age minimum of 18
- AIM III (LCS-SPECIFIC CARE COORDINATORS): Affiliation with Skagit Regional Health System, Confluence Health or Kadlec Regional Medical Center
- AIM III (LCS-SPECIFIC CARE COORDINATORS): Identifies as fulfilling a supportive role in the LCS care continuum as part of the centralizing intervention
Who cannot join
- AIM II: No longer eligible for lung cancer screening chest CT during follow-up period (no longer meeting inclusion criteria during follow-up period)
- AIM II: Request to not participate in the trial
- AIM III (PROVIDER INTERVIEWS): Less than age 18
- AIM III (PROVIDER INTERVIEWS): Do not have an affiliation with Skagit Regional Health System, Confluence Health or Kadlec Regional Medical Center
- AIM III (PROVIDER INTERVIEWS): Does not identify as providing primary care or specialty care to LCS patients (MD, RN, PA, ARNP)
- AIM III (LCS PATIENT INTERVIEWS): Less than age 50 or older than age 80
Show all 10Show fewer
- AIM III (LCS PATIENT INTERVIEWS): Did not receive lung cancer screening at Skagit Regional Health System, Confluence Health or Kadlec Regional Medical Center within the intervention period
- AIM III (LCS PATIENT INTERVIEWS): Was not eligible for LCS at time of performance by USPSTF criteria
- AIM III (LCS-SPECIFIC CARE COORDINATORS): Less than of 18
- AIM III (LCS-SPECIFIC CARE COORDINATORS): Does not have an affiliation with Skagit Regional Health System, Confluence Health or Kadlec Regional Medical Center
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Evaluating Centralizing Interventions to Address Low Adherence to Lung Cancer Screening Follow-Up in Decentralized Settings (The ACCELL Interventional Trial)
This clinical trial tests the impact of lung cancer screening care coordination interventions implemented at the system-level on lung cancer screening adherence in community settings. Lung cancer remains the leading cause of cancer death in the United States. Although lung cancer screening (LCS) with yearly low-dose chest computed tomography has the potential to decrease lung deaths, the use of this screening technique remains low. In addition, studies have shown that adherence to lung cancer screening in clinical settings is far lower that those found in clinical trials. Improved care coordination services that include comprehensive, system-wide tracking of screening outcomes for all LCS participants, results reporting with direct-to-patient information, direct patient and physician communication, and active reviews of non-adherent patients and stepped support interventions may increase patient adherence to LCS. Coordination services at the system-level may decrease barriers and improve adherence to lung cancer screening in community settings.
Read the detailed description
OUTLINE:
Patients receive lung cancer screening follow-up care coordination services, delivered by a lung cancer screening care coordinator at their care site.
- Conditions
- Lung Carcinoma
- Being tested
- Electronic Health Record Review, Interview, Patient Navigation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Health Record ReviewOther
Ancillary studies
InterviewOther
Ancillary studies
Patient NavigationBehavioural
Also called Patient Navigator Program
Receive lung cancer screening care coordination services
| Study group | Role | What they receive |
|---|---|---|
| Screening (LCS coordination) | Experimental | Patients receive lung cancer screening follow-up care coordination services, delivered by a lung cancer screening care coordinator at their care site. Receives: Other: Electronic Health Record Review; Other: Interview; Behavioral: Patient Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to appropriate follow-up
The time and covariate adjusted difference in adherence to appropriate follow-up will be assessed between the pre- and post-intervention period, separately for negative and positive exams. Follow-up will be considered on-time if occurring by the recommended follow up window + 30 days. The impact of the interventions on follow-up will be measured a using generalized estimating equations (GEE)-based approach. The modeling will be done using logistic regression. The Bonferroni correction will be used to account for testing two intervention coefficients.
Measured: Up to 48 months
Secondary outcomes (1)
Characteristics associated with adherence to follow up
The impact of site, patient race/ethnicity, socioeconomic status and patient rurality on adherence will be evaluated in both the pre-intervention and the post-intervention period. The impact of site and patient characteristics on the pre-intervention adherence rate will be evaluated with multivariable logistic regression models using GEE to account for multiple rounds of lung cancer screening within an individual patient. Associations of site and patient characteristics with extent of delay for non-adherent patients will be evaluated using multivariable accelerated failure time models. The overall follow-up rate will be analyzed using multivariable Cox regression models.
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 Mar 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6,772 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Matthew Triplette, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324110
- Sponsor's protocol ID
- RG1124119
- Other IDs
- NCI-2024-01763, 20250, R01CA284032
- Status last verified
- May 2026
- First submitted
- 15 Mar 2024
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Palazzo L, Hansell L, Wernli KJ, Brown M, Snidarich M, Louie T, Long S, Walsh C, Coronado GD, DeCell Arnp K, Lodhi S, Leone RJ, Wysham N, Triplette M. Determinants of lung cancer screening follow-up care in community care settings: A qualitative multi-case study in the ACCELL trial. Chest. 2026 Oct 22:S0012-3692(26)06929-1. doi: 10.1016/j.chest.2026.10.019. Online ahead of print.
PubMed 42913880Louie T, Snidarich M, Hippe DS, Wernli KJ, Palazzo L, Hansell L, Brown M, Coronado GD, Lodhi S, Leone R, DeCell K, Mardesich K, Wysham N, Triplette M. A pragmatic pre-post intervention trial to address adherence to lung cancer screening follow-up in community settings (the ACCELL trial): Study protocol. Contemp Clin Trials. 2025 Dec;159:108106. doi: 10.1016/j.cct.2025.108106. Epub 2025 Oct 10.
PubMed 41076116
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Centralizing Interventions to Address Low Adherence to Lung Cancer Screening Follow-Up in Decentralized Settings (The ACCELL Interventional Trial)
- ClinicalTrials.gov ID
- NCT06324110
- Acronym / sponsor ID
- RG1124119
- Conditions
- Lung Carcinoma
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 6,772 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 21 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.
This clinical trial tests the impact of lung cancer screening care coordination interventions implemented at the system-level on lung cancer screening adherence in community settings. Lung cancer remains the leading cause of cancer death in the United States. Although lung cancer screening (LCS) with yearly low-dose chest computed tomography has the potential to decrease lung deaths, the use of this screening technique remains low. In addition, studies have shown that adherence to lung cancer screening in clinical settings is far lower that those found in clinical trials. Improved care coordination services that include comprehensive, system-wide tracking of screening outcomes for all LCS participants, results reporting with direct-to-patient information, direct patient and physician communication, and active reviews of non-adherent patients and stepped support interventions may increase patient adherence to LCS. Coordination services at the system-level may decrease barriers and improve adherence to lung cancer screening in community settings.
Detailed description
OUTLINE:
Patients receive lung cancer screening follow-up care coordination services, delivered by a lung cancer screening care coordinator at their care site.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening (LCS coordination) | Experimental | Other: Electronic Health Record Review, Other: Interview, Behavioral: Patient NavigationPatients receive lung cancer screening follow-up care coordination services, delivered by a lung cancer screening care coordinator at their care site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- AIM II: Age 50-80
- AIM II: Current or former (within 15 years) smoker
- AIM II: 20+ pack-years of cigarette use
- AIM II: Undergone at least one lung cancer screening low-dose chest computed tomography (CT) at partnering sites within the study period
- AIM III (PROVIDER INTERVIEWS): Age minimum of 18
Key exclusion criteria (10 listed)
- AIM II: No longer eligible for lung cancer screening chest CT during follow-up period (no longer meeting inclusion criteria during follow-up period)
- AIM II: Request to not participate in the trial
- AIM III (PROVIDER INTERVIEWS): Less than age 18
- AIM III (PROVIDER INTERVIEWS): Do not have an affiliation with Skagit Regional Health System, Confluence Health or Kadlec Regional Medical Center
- AIM III (PROVIDER INTERVIEWS): Does not identify as providing primary care or specialty care to LCS patients (MD, RN, PA, ARNP)
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 |
|---|---|---|
| Electronic Health Record ReviewAncillary studies | Other | Screening (LCS coordination) |
| InterviewAncillary studies | Other | Screening (LCS coordination) |
| Patient NavigationAlso: Patient Navigator ProgramReceive lung cancer screening care coordination services | Behavioural | Screening (LCS coordination) |
Primary outcome
Adherence to appropriate follow-up
Time frame: Up to 48 months
The time and covariate adjusted difference in adherence to appropriate follow-up will be assessed between the pre- and post-intervention period, separately for negative and positive exams. Follow-up will be considered on-time if occurring by the recommended follow up window + 30 days. The impact of the interventions on follow-up will be measured a using generalized estimating equations (GEE)-based approach. The modeling will be done using logistic regression. The Bonferroni correction will be used to account for testing two intervention coefficients.
1 secondary outcome
Characteristics associated with adherence to follow up
Time frame: Up to 48 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 18 May 2026.
- Derived from this study: PubMed 42913880Palazzo L, Hansell L, Wernli KJ, Brown M, Snidarich M, Louie T, Long S, Walsh C, Coronado GD, DeCell Arnp K, Lodhi S, Leone RJ, Wysham N, Triplette M. Determinants of lung cancer screening follow-up care in community care settings: A qualitative multi-case study in the ACCELL trial. Chest. 2026 Oct 22:S0012-3692(26)06929-1. doi: 10.1016/j.chest.2026.10.019. Online ahead of print.
- Derived from this study: PubMed 41076116Louie T, Snidarich M, Hippe DS, Wernli KJ, Palazzo L, Hansell L, Brown M, Coronado GD, Lodhi S, Leone R, DeCell K, Mardesich K, Wysham N, Triplette M. A pragmatic pre-post intervention trial to address adherence to lung cancer screening follow-up in community settings (the ACCELL trial): Study protocol. Contemp Clin Trials. 2025 Dec;159:108106. doi: 10.1016/j.cct.2025.108106. Epub 2025 Oct 10.
- Individual participant dataSharing planned: No
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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.
Matthew Triplette principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Health Record Review, Interview and Patient Navigation in people with Lung Carcinoma, run by Fred Hutchinson Cancer Center 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 16 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 18 May 2026. 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?
Adherence to appropriate follow-up (time frame: Up to 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06324110, which also lists 2 linked publications.
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 18 May 2026.