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

Lung Carcinoma Clinical Trial

Official title:

Evaluating Centralizing Interventions to Address Low Adherence to Lung Cancer Screening Follow-Up in Decentralized Settings (The ACCELL Interventional Trial)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06324110
• Other study ID #: RG1124119
• Secondary ID: NCI-2024-0176320
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: March 2024
• Source: Fred Hutchinson Cancer Center
• Contact: Tinnie Louie
• Phone: 206-667-3323
• Email: tlouie[@]fredhutch.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Description:

OUTLINE:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8658
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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: Death during the follow-up period

• AIM II: Documented move out of healthcare system

• 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

Related Conditions & MeSH terms

• Lung Carcinoma
• Lung Neoplasms

Intervention

Other:
• Electronic Health Record Review
Ancillary studies
• Interview
Ancillary studies

Behavioral:
• Patient Navigation
Receive lung cancer screening care coordination services

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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