Improving Utilization of Lung Cancer Screening in Underserved PA Populations

NCT ID: NCT04806399

Last Updated: 2024-10-15

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

2500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-30

Study Completion Date

2024-11-30

Brief Summary

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This study is an interventional study intended to assess the impact of a centralized outreach intervention that includes shared decision-making about lung cancer screening (LCS) in LCS-eligible primary care patients. The study's goal is to increase LCS rates compared to usual care and thus reduce lung cancer deaths.

Detailed Description

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The research team will select primary care practices included in areas where lung cancer mortality is high. An outreach registry of primary care patients obtaining care at participating practices who meet study eligibility criteria will be created from the electronic medical record. 500 primary care patients will be randomly selected for the Outreach Contact with Decision Counseling (OCDC) Group from this outreach registry. Patients targeted for inclusion in the study will have a scheduled primary care appointment 18-23 days after initial outreach contact.

Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly selected for assignment to the Outreach Contact with Decision Counseling Group or randomly selected for assignment to a Usual Care Control Group
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Usual Care Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Outreach Contact with Decision Counseling Group

Group Type ACTIVE_COMPARATOR

Educational Materials and Decision Counseling

Intervention Type OTHER

Participants in the active comparator arm will receive an introductory letter and lung cancer screening educational materials. A site care coordinator will contact each participant post receiving materials.

Interventions

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Educational Materials and Decision Counseling

Participants in the active comparator arm will receive an introductory letter and lung cancer screening educational materials. A site care coordinator will contact each participant post receiving materials.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Have an upcoming office visit with a primary care physician in one of the study practices
* Between the ages of 50 and 77 (inclusive)
* History of smoking (current or former) in the electronic medical record (EMR)

Exclusion Criteria

* Chest CT performed in the last 10 months before study initiation according to EMR
* Diagnosis of lung cancer indicated in the problem list in the EMR
* Current cancer treatment or other qualifying diagnoses that would make outreach inappropriate (e.g., dementia, hearing disability)
Minimum Eligible Age

50 Years

Maximum Eligible Age

77 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Thomas Jefferson University

OTHER

Sponsor Role collaborator

American College of Radiology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Etta Pisano, MD

Role: PRINCIPAL_INVESTIGATOR

American College of Radiology

Ronald Myers, PhD

Role: STUDY_CHAIR

Jefferson Health System

Locations

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Lehigh Valley Health Network

Allentown, Pennsylvania, United States

Site Status

Jefferson Health System

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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Cure 16

Identifier Type: -

Identifier Source: org_study_id

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