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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06252545
Other study ID # LCCC2234
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 2, 2024
Est. completion date October 31, 2025

Study information

Verified date June 2024
Source UNC Lineberger Comprehensive Cancer Center
Contact Lori Stravers
Phone 1 919-966-4432
Email lori_stravers@med.unc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To develop a culturally tailored informational mobile application and test whether it will increase participation among Black pancreatic cancer subjects in clinical trial discussions with their care team. This project aims to identify and address barriers to enrollment of Black subjects in pancreatic cancer clinical trials using a culturally informed mobile health application to promote participation. The clinical trial education and communication needs of Black people with pancreatic cancer will be determined. A new mHealth application for clinical trial education and communication tailored to subject needs will be developed. It was hypothesized that a culturally tailored informational mobile application will increase the participation of Black subjects in clinical trial discussions with their care team among the target population. This study focuses on Black pancreatic cancer subjects, who experience higher mortality rates and lower clinical trial participation than White subjects. Research shows that the disparity between clinical trial participation is in part due to inequitable recruitment practices. This study will use mobile application technology (mHealth app) as an educational, communication, audit, and feedback tool to promote patient-initiated clinical trial discussions among Black people with pancreatic cancer and their cancer care team.


Recruitment information / eligibility

Status Recruiting
Enrollment 26
Est. completion date October 31, 2025
Est. primary completion date October 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria Participants must meet the following inclusion criteria in order to participate in communication & education interview component of the study: 1. Informed consent obtained to participate in the study 2. 18 years or older 3. English speaking 4. Able and willing to participate in a 1-hour interview 5. History of pancreatic cancer diagnosis 6. Identify as Black Exclusion Criteria: All participants meeting any of the following exclusion criteria will be excluded from the study: 1. Inability to read and speak English 2. Dementia altered mental status, or any psychiatric condition that would prohibit understanding or rendering of informed consent as determined by the study physician.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
semistructured interviews
Black subjects with pancreatic cancer will provide insight on their experience discussing clinical trials and preferences for communicating clinical trial information
feedback
Black subjects with pancreatic cancer will provide feedback on mHealth app prototype.

Locations

Country Name City State
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States Medical College Of Wisconsin Milwaukee Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
UNC Lineberger Comprehensive Cancer Center Lustgarten Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The clinical trial education and communication needs The clinical trial education and communication needs of Black people with pancreatic cancer will be determined with feedback and qualitative analysis of findings from semi-structured interviews to develop an mHealth application. Up to 1 month
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