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Trial Title:
Evaluating the Impact of Centralized Interventions on Lung Cancer Screening Adherence in Community Settings, ACCELL Trial
NCT ID:
NCT06324110
Condition:
Lung Carcinoma
Conditions: Official terms:
Lung Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Ancillary studies
Arm group label:
Screening (LCS coordination)
Intervention type:
Other
Intervention name:
Interview
Description:
Ancillary studies
Arm group label:
Screening (LCS coordination)
Intervention type:
Behavioral
Intervention name:
Patient Navigation
Description:
Receive lung cancer screening care coordination services
Arm group label:
Screening (LCS coordination)
Other name:
Patient Navigator Program
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.
Criteria for 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 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Fred Hutch/University of Washington Cancer Consortium
Address:
City:
Seattle
Zip:
98109
Country:
United States
Start date:
February 1, 2025
Completion date:
June 30, 2027
Lead sponsor:
Agency:
Fred Hutchinson Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Fred Hutchinson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06324110