- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06252545
Promoting CT Engagement for Pancreatic Cancer With App (PROCLAIM)
PROmoting CLinicAl TrIal EngageMent for Pancreatic Cancer App Study (PROCLAIM Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lori Stravers
- Phone Number: 1 919-966-4432
- Email: lori_stravers@med.unc.edu
Study Contact Backup
- Name: Maddy Ledenyi
- Phone Number: (919) 843-4699
- Email: Madeleine_Ledenyi@med.unc.edu
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- Recruiting
- UNC Lineberger Comprehensive Cancer Center
-
Contact:
- Lori Stravers
- Phone Number: 919-966-4432
- Email: Lori_Stravers@med.unc.edu
-
Principal Investigator:
- Jen Jen Yeh, MD
-
Contact:
- Maddy Ledenyi
- Phone Number: +1 919-843-4699
- Email: Madeleine_Ledenyi@med.unc.edu
-
-
Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Recruiting
- Medical College of Wisconsin
-
Contact:
- Christian Campbell
- Phone Number: +1 414-955-1423
- Email: ccampbell@mcw.edu
-
Principal Investigator:
- Ugwuji Maduekwe, MD, MMSc, MPH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
Participants must meet the following inclusion criteria in order to participate in communication & education interview component of the study:
- Informed consent obtained to participate in the study
- 18 years or older
- English speaking
- Able and willing to participate in a 1-hour interview
- History of pancreatic cancer diagnosis
- Identify as Black
Exclusion Criteria:
All participants meeting any of the following exclusion criteria will be excluded from the study:
- Inability to read and speak English
- Dementia altered mental status, or any psychiatric condition that would prohibit understanding or rendering of informed consent as determined by the study physician.
Study Plan
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 |
|---|---|
|
Other: Interview Group
Subjects with pancreatic carcinoma who joined the interview group.
|
Black subjects with pancreatic cancer will provide insight on their experience discussing clinical trials and preferences for communicating clinical trial information
|
|
Other: User Testing Group
Subjects with pancreatic carcinoma who joined the user testing group
|
Black subjects with pancreatic cancer will provide feedback on mHealth app prototype.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The clinical trial education and communication needs
Time Frame: Up to 1 month
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jen J Yeh, MD, UNC Lineberger Comprehensive Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCCC2234
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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