Evaluating the Impact of Centralized Interventions on Lung Cancer Screening Adherence in Community Settings, ACCELL Trial

NCT ID: NCT06324110

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 6772 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2027-09-30

Brief 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. 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.

Conditions

Lung Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Screening (LCS coordination)

Patients receive lung cancer screening follow-up care coordination services, delivered by a lung cancer screening care coordinator at their care site.

Group Type: EXPERIMENTAL

Electronic Health Record Review

Intervention Type: OTHER

Ancillary studies

Interview

Intervention Type: OTHER

Ancillary studies

Patient Navigation

Intervention Type: BEHAVIORAL

Receive lung cancer screening care coordination services

Interventions

Electronic Health Record Review

Ancillary studies

Intervention Type: OTHER

Interview

Ancillary studies

Intervention Type: OTHER

Patient Navigation

Receive lung cancer screening care coordination services

Intervention Type: BEHAVIORAL

Other Intervention Names

Patient Navigator Program

Eligibility Criteria

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

• 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

• 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Triplette

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Countries

United States

References

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 Oct 10;159:108106. doi: 10.1016/j.cct.2025.108106. Online ahead of print.

Reference Type: DERIVED

PMID: 41076116 (View on PubMed)

Other Identifiers

NCI-2024-01763

Identifier Type: REGISTRY

Identifier Source: secondary_id

20250

Identifier Type: OTHER

Identifier Source: secondary_id

R01CA284032

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RG1124119

Identifier Type: -

Identifier Source: org_study_id