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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Lung Carcinoma
• Intervention / Treatment: Other: Interview; Other: Electronic Health Record Review; Behavioral: Patient Navigation

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 Type: Interventional
• Enrollment (Estimated): 6772
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Interview; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Behavioral: Patient Navigation; Receive lung cancer screening care coordination services; Other Names: Patient Navigator Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	Up to 48 months

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Matthew Triplette, Fred Hutch/University of Washington Cancer Consortium

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: March 15, 2024
• First Submitted That Met QC Criteria: March 15, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Patient Care Management; Comprehensive Health Care; Patient-Centered Care; Primary Health Care; Interviews as Topic; Patient Navigation
• Other Study ID Numbers: RG1124119; 20250 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); NCI-2024-01763 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R01CA284032 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No