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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
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This is a West Philadelphia based community project to improve adherence to lung cancer screening. The overall objective of this project is to demonstrate the impact of a community support program (CSP) on improve adherence to LCS follow-up guidelines in an urban environment. The study will target individuals in the Penn Medicine healthcare system residing in Philadelphia with an upcoming or missed follow-up screening or orders placed but who have not yet scheduled their screenings by offering free transportation coordination to and from the appointment. The study team will also offer to connect those with placed but unscheduled low dose CT orders to connect with Penn Medicine's scheduling staff.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| West Philadelphia | Experimental | Eligible patient population lives in West Philadelphia |
|
| Southwest Philadelphia | No Intervention | Eligible patient population lives in Southwest Philadelphia |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transportation | Behavioral | Participants with ordered low dose CT and participants with scheduled low dose CT are offered free transportation to and from appointment. Participants with ordered low dose CT are also offered assistance in connecting with scheduling staff. |
| Measure | Description | Time Frame |
|---|---|---|
| Scheduled Lung Cancer Screening Appointments Attended by Participants | The Primary Outcome measures appointment attendance across three groups: West Philadelphia CSP Participants (eligible West Philadelphia residents who opted into the CSP), West Philadelphia Non CSP Participants (eligible West Philadelphia residents who did not opt into the CSP), and Southwest Philadelphia Residents (patients who did not receive an option to participate in the CSP). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| CSP Enrollment | The Secondary outcome is a measurement of the how many eligible participants (West Philadelphia residents) chose to opt into the CSP (as opposed to eligible participants who did not). | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Farouk Dako, MD | farouk.dako@pennmedicine.upenn.edu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univeristy of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1. West Philadelphia CSP Participants | 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. This group opted into the CSP. |
| FG001 | 2. West Philadelphia Non CSP Participants | 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. This group did not opt into the CSP. |
| FG002 | 3. Southwest 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1. West Philadelphia CSP Participants | 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. This group opted into the CSP. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Scheduled Lung Cancer Screening Appointments Attended by Participants | The Primary Outcome measures appointment attendance across three groups: West Philadelphia CSP Participants (eligible West Philadelphia residents who opted into the CSP), West Philadelphia Non CSP Participants (eligible West Philadelphia residents who did not opt into the CSP), and Southwest Philadelphia Residents (patients who did not receive an option to participate in the CSP). | Posted | Count of Participants | Participants | 12 months |
|
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Adverse events were not assessed. The only intervention provided was assistance with scheduling and optional transportation for a clinical scan already scheduled by the patient's care team.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1. West Philadelphia CSP Participants | 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. This group opted into the CSP. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Farouk Dako | University of Pennsylvania | 2673091241 | farouk.dako@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 2, 2024 | Mar 3, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 21, 2024 | Aug 26, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D014186 | Transportation |
| D001071 | Appointments and Schedules |
| ID | Term |
|---|---|
| D013676 | Technology, Industry, and Agriculture |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| Scheduling | Behavioral | Participants with ordered low dose CT are offered assistance in connecting with scheduling staff. |
|
| BG001 | 2. West Philadelphia Non CSP Participants | 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. This group did not opt into the CSP. |
| BG002 | 3. Southwest 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Scheduled Lung Cancer Screening | Count of Participants | Participants |
|
| OG001 | 2. West Philadelphia Non CSP Participants | 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. This group did not opt into the CSP. |
| OG002 | 3. Southwest 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. |
|
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| Secondary | CSP Enrollment | The Secondary outcome is a measurement of the how many eligible participants (West Philadelphia residents) chose to opt into the CSP (as opposed to eligible participants who did not). | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 2. West Philadelphia Non CSP Participants | 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. This group did not opt into the CSP. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 3. Southwest 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |