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Improving Utilization of Lung Cancer Screening in Underserved PA Populations

Primary Purpose

Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Materials and Decision Counseling
Sponsored by
American College of Radiology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Lung Cancer focused on measuring Screening Utilization

Eligibility Criteria

50 Years - 77 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Have an upcoming office visit with a primary care physician in one of the study practices
  • Between the ages of 55 and 77 (inclusive)
  • History of smoking (current or former) in the electronic medical record (EMR)

Exclusion Criteria:

  • Chest CT performed in the last 12 months before study initiation according to EMR
  • Diagnosis of lung cancer indicated in the problem list in the EMR
  • Primary language is not English
  • Current cancer treatment or other qualifying diagnoses that would make outreach inappropriate (e.g., dementia, hearing disability)

Sites / Locations

  • Lehigh Valley Health Network
  • Jefferson Health SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Usual Care Control Group

Outreach Contact with Decision Counseling Group

Arm Description

Outcomes

Primary Outcome Measures

Assess impact of a centralized outreach intervention that includes shared decision-making (SDM) on lung cancer screening rates compared to usual care.
Implement a centralized outreach intervention that includes shared decision-making (SDM) about lung cancer screening (LCS) (screening eligibility assessment, education, and decision support) in LCS-eligible primary care patients. The study's ultimate goal is to increase LCS rates compared to usual care and thus reduce lung cancer deaths.

Secondary Outcome Measures

Full Information

First Posted
January 8, 2021
Last Updated
April 10, 2023
Sponsor
American College of Radiology
Collaborators
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT04806399
Brief Title
Improving Utilization of Lung Cancer Screening in Underserved PA Populations
Official Title
Improving Utilization of Lung Cancer Screening in Underserved PA Populations
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American College of Radiology
Collaborators
Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Screening Utilization

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care Control Group
Arm Type
No Intervention
Arm Title
Outreach Contact with Decision Counseling Group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Educational Materials and Decision Counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assess impact of a centralized outreach intervention that includes shared decision-making (SDM) on lung cancer screening rates compared to usual care.
Description
Implement a centralized outreach intervention that includes shared decision-making (SDM) about lung cancer screening (LCS) (screening eligibility assessment, education, and decision support) in LCS-eligible primary care patients. The study's ultimate goal is to increase LCS rates compared to usual care and thus reduce lung cancer deaths.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
77 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irene Mahon
Phone
215-574-3249
Email
imahon@acr.org
First Name & Middle Initial & Last Name or Official Title & Degree
Donna Hartfeil
Phone
215-717-2765
Email
dhartfeil@acr.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Etta Pisano, MD
Organizational Affiliation
American College of Radiology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ronald Myers, PhD
Organizational Affiliation
Jefferson Health System
Official's Role
Study Chair
Facility Information:
Facility Name
Lehigh Valley Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18105
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Johnson, MPA
Phone
484-862-3073
Email
melanie_bjohnson@lvhn.org
Facility Name
Jefferson Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa DiCarlo, MPH, MS
Phone
215-503-9348
Email
melissa.dicarlo@jefferson.edu
First Name & Middle Initial & Last Name & Degree
Ronald Myers, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Improving Utilization of Lung Cancer Screening in Underserved PA Populations

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