Community Support Program for Lung Cancer Screening (LCS)

March 11, 2024 updated by: University of Pennsylvania
The research study aims to create a program for lung cancer screening attendance

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The overall objective of this project is to demonstrate the impact of a community support program (CSP) on improving adherence to LCS follow-up guidelines in an urban environment. The project aims to collaborate with community partners to develop an infrastructure and iterative process to provide social support to community members that facilitates obtaining their follow-up LDCT for LCS. It utilizes novel population level data that includes geospatial analysis of neighborhood-level data of patients residing in Philadelphia who have received a LDCT for LCS. This allows for targeted community level interventions and the ability to evaluate impact on a population level.

A Community Support Program Representative will reach out to eligible patients via telephone. The CSP Representative and Patient Navigator will communicate with consented patient directly, assist with travel and the appointment. The PN will log the date of the appointment, zip code of the patient and the adherence (or lack of) of the appointment completion. We will utilize Lyft transportation vouchers to provide rides to participants from their home location in West Philadelphia to and from the Penn Medicine downtown hospital locations on the day of their LDCT.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Upcoming or missed follow-up LDCT (low dose CT)
  • West Philadelphia resident
  • Between 18-89 years' old

Exclusion Criteria:

  • No upcoming LDCT
  • Lives outside West Philadelphia
  • Outside age range

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: West Philadelphia Residents
For eligible residents of West Philadelphia, patients are contacted by Community Support Program Representative and offered free Lyft transportation to and from appointment. If patient has other questions about their upcoming appointment (location, time, etc.), Patient Navigator assists in answering questions
Behavioral: Transportation
Eligible patients are contacted and offered free transportation to and from their upcoming appointment.
No Intervention: Non West Philadelphia Residents
For patients outside West Philadelphia, no contact is made and no free transportation is provided. Research coordinator logs their appointment attendance after the appointment date in question.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Develop a community support program for lung cancer screening adherence
Time Frame: 12 months
A consortium of representatives chosen by an established community center with a track record of providing social services to their surrounding communities and Penn Medicine multidisciplinary team will be formed and will work to develop rules of operation and decision making for the community support program (CSP). Penn Medicine team members include researchers in radiology, implementation science, and a patient navigator (PN). Representatives from academia and the community will engage in reciprocal learning sessions to create CSP material that is socially and culturally sensitive to the needs of the community. Initial community support will be developed based on preliminary data and evidence that two of the main barriers to utilization of lung cancer screening are transportation cost/availability and limited education about lung cancer screening.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure the impact of the community support program in improving adherence to lung cancer screening follow-up
Time Frame: 12 months
A prospective study would be designed to measure the impact of the CSP on a population level by utilizing aggregated neighborhood level data. The database contains information of patients who received baseline LCS with individual level residential address geocoded to determine neighborhood level characteristics. The West Philadelphia planning district will be chosen as the intervention group because it is within the catchment area of Penn Medicine, has the highest number of LCS patients and is one of the districts noted to have consistent high rates of smoking prevalence and lung cancer mortality. The control group would be individuals residing in the adjacent Southwest Philadelphia planning district which has a similar Yost score - a composite index of socioeconomic status. Patients will be stratified into those with upcoming or missed appointment with primary analysis focused on patients with upcoming appointments.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Farouk Dako, MD, MPH, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2023

Primary Completion (Estimated)

August 10, 2024

Study Completion (Estimated)

August 29, 2024

Study Registration Dates

First Submitted

December 20, 2023

First Submitted That Met QC Criteria

January 4, 2024

First Posted (Actual)

January 17, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 852598

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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