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Recruiting NCT06252545

Promoting CT Engagement for Pancreatic Cancer With App

No phase Interventional Pancreas Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: semistructured interviews, feedback.
Who it may be relevant to
Registry conditions: Pancreas Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

PROmoting CLinicAl TrIal EngageMent for Pancreatic Cancer App Study (PROCLAIM Study

Overview

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.

Interventions

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

Primary outcome measures

  • The clinical trial education and communication needs [Time frame: Up to 1 month]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 2 centers
  • UNC Lineberger Comprehensive Cancer Center — Chapel Hill
  • Medical College Of Wisconsin — Milwaukee

Identifiers

NCT: NCT06252545 · LCCC2234

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗