Lung Cancer Screening Protocol

NCT ID: NCT03958253

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

193 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-22

Study Completion Date

2021-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Cancer Screening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Lung Cancer Screening Toolbox

* 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.

Group Type EXPERIMENTAL

Toolbox for Lung Cancer Screening

Intervention Type 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

Interventions

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Toolbox for Lung Cancer Screening

-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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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BJC HealthCare, Barnes-Jewish St. Peters Hospital

UNKNOWN

Sponsor Role collaborator

Decatur Memorial Hospital

UNKNOWN

Sponsor Role collaborator

Memorial Health System

OTHER

Sponsor Role collaborator

Sarah Bush Lincoln Health System

UNKNOWN

Sponsor Role collaborator

Southern Illinois Healthcare

UNKNOWN

Sponsor Role collaborator

Cox Health Systems

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aimee S James, Ph.D., MPH

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Graham A Colditz, M.D., DrPH

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Southern Illinois Healthcare

Carbondale, Illinois, United States

Site Status

Decatur Memorial Hospital

Decatur, Illinois, United States

Site Status

Sarah Bush Lincoln Health System

Mattoon, Illinois, United States

Site Status

Memorial Health System

Springfield, Illinois, United States

Site Status

BJC HealthCare, Barnes-Jewish St. Peters Hospital

City of Saint Peters, Missouri, United States

Site Status

CoxHealth

Springfield, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32184197 (View on PubMed)

Related Links

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http://www.siteman.wustl.edu

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

Other Identifiers

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201811093

Identifier Type: -

Identifier Source: org_study_id

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