Improving Utilization of Lung Cancer Screening in Underserved PA Populations

NCT04806399 | Active Not Recruiting

• 1 other identifier: Cure 16
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Cancer

Keywords

Screening Utilization

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Study Arms (2)

Usual Care Control Group

NO INTERVENTION

Outreach Contact with Decision Counseling Group

ACTIVE COMPARATOR

Other: Educational Materials and Decision Counseling

Interventions

Educational Materials and Decision Counseling 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.

Outreach Contact with Decision Counseling Group

Eligibility Criteria

• Age: 50 Years - 77 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• American College of Radiology: lead
• Thomas Jefferson University: collaborator

Study Sites (2)

Lehigh Valley Health Network

Allentown, Pennsylvania, 18105, United States

Location

Jefferson Health System

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Etta Pisano, MD

  American College of Radiology

  PRINCIPAL INVESTIGATOR

• Ronald Myers, PhD

  Jefferson Health System

  STUDY CHAIR

Study Design

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

Model Details: 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

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: March 19, 2021
• Study Start: March 30, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)