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

NCT06324110 | Enrolling By Invitation DMC

• 4 other identifiers: RG1124119NCI-2024-0176320250R01CA284032
• Study Type: interventional
• Target: 6,772
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Characteristics associated with adherence to follow up

  Up to 48 months

Study Arms (1)

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.

Other: Electronic Health Record Review; Other: Interview; Behavioral: Patient Navigation

Interventions

Electronic Health Record Review OTHER

Ancillary studies

Screening (LCS coordination)

Interview OTHER

Ancillary studies

Screening (LCS coordination)

Patient Navigation BEHAVIORAL

Receive lung cancer screening care coordination services

Also known as: Patient Navigator Program

Screening (LCS coordination)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• 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.

  PMID: 41076116 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Interviews as Topic; Patient Navigation

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Matthew Triplette

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 21, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)