Improving Utilization of Lung Cancer Screening in Underserved PA Populations

Sponsor

American College of Radiology (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04806399

Collaborator

Thomas Jefferson University (Other)

2,500

Enrollment

Locations

Arms

Anticipated Duration (Months)

1250

Patients Per Site

48.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Other: Educational Materials and Decision Counseling	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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 GroupParticipants 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)

Primary Purpose:

Screening

Official Title:

Improving Utilization of Lung Cancer Screening in Underserved PA Populations

Anticipated Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual Care Control Group
Active Comparator: Outreach Contact with Decision Counseling Group	Other: 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.

Arm

Intervention/Treatment

No Intervention: Usual Care Control Group

Active Comparator: Outreach Contact with Decision Counseling Group

Other: 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.

Outcome Measures

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. [24 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 77 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lehigh Valley Health Network	Allentown	Pennsylvania	United States	18105
2	Jefferson Health System	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

American College of Radiology
Thomas Jefferson University

Investigators

Principal Investigator: Etta Pisano, MD, American College of Radiology
Study Chair: Ronald Myers, PhD, Jefferson Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

American College of Radiology

ClinicalTrials.gov Identifier:

NCT04806399

Other Study ID Numbers:

Cure 16

First Posted:

Mar 19, 2021

Last Update Posted:

Mar 19, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by American College of Radiology

Screening Utilization

Additional relevant MeSH terms:

Lung Neoplasms

Study Results

No Results Posted as of Mar 19, 2021