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Promoting CT Engagement for Pancreatic Cancer With App


2024-02-02


2027-02-01


2027-02-01


26

Study Overview

Promoting CT Engagement for Pancreatic Cancer With App

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.

N/A

  • Pancreas Cancer
  • BEHAVIORAL: semistructured interviews
  • BEHAVIORAL: feedback
  • LCCC2234

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 Registration Dates Results Reporting Dates Study Record Updates

2024-02-01  

N/A  

2025-05-09  

2024-02-01  

N/A  

2025-05-13  

2024-02-09  

N/A  

2025-05  

Study Plan

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

Design Details

Primary Purpose:
Health Services Research


Allocation:
Non Randomized


Interventional Model:
Parallel


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
OTHER: Interview Group

Subjects with pancreatic carcinoma who joined the interview group.

BEHAVIORAL: semistructured interviews

  • 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

BEHAVIORAL: feedback

  • Black subjects with pancreatic cancer will provide feedback on mHealth app prototype.
Primary Outcome MeasuresMeasure DescriptionTime Frame
The clinical trial education and communication needsThe 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
Secondary Outcome MeasuresMeasure DescriptionTime Frame

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

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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.

Collaborators and Investigators

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

  • Lustgarten Foundation

  • PRINCIPAL_INVESTIGATOR: Jen J Yeh, MD, UNC Lineberger Comprehensive Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available