Clinical trial NCT06252545: Promoting CT Engagement for Pancreatic Cancer With App
Official title: PROmoting CLinicAl TrIal EngageMent for Pancreatic Cancer App Study (PROCLAIM Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreas Cancer
Keywords: ethnicity
black
application
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Lustgarten Foundation
First posted: 2024-02-09
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be 2 groups: 20 subjects with pancreas carcinoma for phone interviews and 6 for user testing the first version of the application..
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The clinical trial education and communication needs
timeFrame: Up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Lineberger Comprehensive Cancer Center
state: North Carolina
city: Milwaukee
country: United States
facility: Medical College Of Wisconsin
state: Wisconsin
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Jen J Yeh, MD
role: PRINCIPAL_INVESTIGATOR
References: