Lung Cancer Screening Protocol

NCT03958253 | Completed

• 1 other identifier: 201811093
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 7

Brief Summary

The successful implementation of lung cancer screening across diverse setting requires working with the community and primary care practices. Collaborating across diverse community-based sites will employ local knowledge and culture in the understanding of the health problem and identifying and implementing solutions that are appropriate for all partners (patients, primary care, referral centers). Enhanced, culturally-competent communication with patients at high risk for lung cancer can narrow inequities in screening awareness, referral, and utilization, as well as improve lung cancer outcomes across diverse patients and communities. Promoting partnerships among physicians, staff, and patients; creating routines; and tailoring materials to each clinician's situation have been show to increase the proportion of patients receiving screening.

Conditions

Lung Cancer Screening

Outcome Measures

Primary Outcomes (1)

• Number of initial low-dose CT (LDCT) scan screenings per month per screening center

  -Screening will be defined as completed initial screen for lung cancer

  Completion of study (estimated to be 21 months)

Secondary Outcomes (3)

• Number of primary care providers who refer at least two patients per month for LDCT

  Completion of study (estimated to be 21 months)

• Percent of patients referred who are screen-eligible

  Completion of study (estimated to be 21 months)

• Percent of patients referred who complete screening

  Completion of study (estimated to be 21 months)

Study Arms (1)

Lung Cancer Screening Toolbox

EXPERIMENTAL

* WU Staff will train local screening staff using a train-the-trainer model three months prior to the intervention and will provide technical assistance on an ongoing basis. * During the 3 hour train-the-trainer session, the selected staff from the referral sites will learn about the program, receive an orientation to the toolbox elements, and discuss how to adapt the elements of the toolbox to their referral sites.

Other: Toolbox for Lung Cancer Screening

Interventions

Toolbox for Lung Cancer Screening OTHER

-Toolbox of evidence-based elements that a primary care or referral site could implement to address known barriers to screening and referral, as well as required elements for screening. These elements will be designed to be adaptable to the unique needs and screening processes of the participating practices. * Patient education materials * Primary care practice educational materials * Pack-years/eligibility calculator * Local referral process guide * Smoking cessation materials and support * Shared decision-making guide * LDCT best practice guidelines

Lung Cancer Screening Toolbox

Eligibility Criteria

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

You may qualify if:

• To be eligible to participate in the trial, screening centers have to be existing members of the BJC Collaborative.
• Primary Care Providers have to have a referral relationship with the screening center; serve adult patients who may be screening-eligible, and are willing to interact with the referral site to implement referral for LDCT.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• BJC HealthCare, Barnes-Jewish St. Peters Hospital: collaborator
• Decatur Memorial Hospital: collaborator
• Memorial Health System: collaborator
• Sarah Bush Lincoln Health System: collaborator
• Southern Illinois Healthcare: collaborator
• Cox Health Systems: collaborator

Study Sites (7)

Southern Illinois Healthcare

Carbondale, Illinois, 62901, United States

Location

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

Sarah Bush Lincoln Health System

Mattoon, Illinois, 61938, United States

Location

Memorial Health System

Springfield, Illinois, 62702, United States

Location

BJC HealthCare, Barnes-Jewish St. Peters Hospital

City of Saint Peters, Missouri, 63376, United States

Location

CoxHealth

Springfield, Missouri, 65802, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Salazar AS, Sekhon S, Rohatgi KW, Nuako A, Liu J, Harriss C, Brennan E, LaBeau D, Abdalla I, Schulze C, Muenks J, Overlot D, Higgins JA, Jones LS, Swick C, Goings S, Badiu J, Walker J, Colditz GA, James AS. A stepped-wedge randomized trial protocol of a community intervention for increasing lung screening through engaging primary care providers (I-STEP). Contemp Clin Trials. 2020 Apr;91:105991. doi: 10.1016/j.cct.2020.105991. Epub 2020 Mar 14.

  PMID: 32184197 DERIVED

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study Officials

• Aimee S James, Ph.D., MPH

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Graham A Colditz, M.D., DrPH

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: This is a stepped wedge cluster randomized trial in which the intervention condition (toolbox) is sequentially assigned to participating hospitals (screening centers) in 6 clusters at different time-delays and where pre-intervention data serves as the control. By the end of the study, all clusters have been exposed to the intervention and each cluster has provided data for the control and intervention conditions. Independent samples of primary care providers are enrolled at each period within a cluster, thus, it is a repeated cross-sectional study. The order of the entry into the intervention phase is randomized based on levels of readiness

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 21, 2019
• Study Start: April 22, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning in 3 months and ending 5 years following article publication
• Access Criteria: Proposals should be directed to aimeejames@wustl.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (7)