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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-01763 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 20250 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| R01CA284032 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OUTLINE:
Patients receive lung cancer screening follow-up care coordination services, delivered by a lung cancer screening care coordinator at their care site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic Health Record Review | Other | Ancillary studies |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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
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
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Triplette | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41076116 | Derived | Louie 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. |
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| Interview |
| Other |
Ancillary studies |
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| Patient Navigation | Behavioral | Receive lung cancer screening care coordination services |
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| Up to 48 months |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| D062526 | Patient Navigation |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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