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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06207435
Other study ID # 852598
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 10, 2023
Est. completion date August 29, 2024

Study information

Verified date March 2024
Source University of Pennsylvania
Contact Kathleen Thomas, MSOD
Phone 2157460352
Email kathleen.thomas@pennmedicine.upenn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The research study aims to create a program for lung cancer screening attendance


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date August 29, 2024
Est. primary completion date August 10, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 89 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Transportation
Eligible patients are contacted and offered free transportation to and from their upcoming appointment.

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Develop a community support program for lung cancer screening adherence 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 Measure the impact of the community support program in improving adherence to lung cancer screening follow-up 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
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