26 Participants Needed

Mobile App for Pancreatic Cancer

(PROCLAIM Trial)

Recruiting at 1 trial location
BH
LS
ML
Overseen ByMaddy Ledenyi
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: UNC Lineberger Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Promoting CT Engagement for Pancreatic Cancer With App?

The research does not directly address the effectiveness of the app treatment, but studies show that structured reporting of CT scans can improve the quality of staging for pancreatic cancer, which might indirectly support the app's goal of promoting better CT engagement.12345

How does the mobile app treatment for pancreatic cancer differ from other treatments?

The mobile app for pancreatic cancer is unique because it likely involves a digital approach to managing the condition, which is different from traditional treatments like surgery, chemotherapy, or radiation. This app might offer innovative ways to monitor symptoms, provide patient education, or support treatment adherence, which are not typically features of standard medical treatments.46789

What is the purpose of this trial?

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.

Research Team

JJ

Jen J. Yeh

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria

This clinical trial is specifically for Black individuals who have been diagnosed with pancreatic cancer. It aims to address the low participation of this group in clinical trials by using a mobile health application designed to encourage discussions about trials with their healthcare team.

Inclusion Criteria

Informed consent obtained to participate in the study
English speaking
Identify as Black
See 2 more

Exclusion Criteria

Dementia altered mental status, or any psychiatric condition that would prohibit understanding or rendering of informed consent as determined by the study physician.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Interview and User Testing

Subjects with pancreatic carcinoma participate in interviews and user testing to determine clinical trial education and communication needs

Up to 1 month

Follow-up

Participants are monitored for feedback and effectiveness of the mHealth application

4 weeks

Treatment Details

Interventions

  • Promoting CT Engagement for Pancreatic Cancer With App
Trial Overview The intervention being tested is a culturally tailored informational mobile app, which will be used as an educational and communication tool. The goal is to see if this app increases engagement between Black pancreatic cancer patients and their care teams regarding clinical trial opportunities.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: User Testing GroupExperimental Treatment1 Intervention
Subjects with pancreatic carcinoma who joined the user testing group
Group II: Interview GroupExperimental Treatment1 Intervention
Subjects with pancreatic carcinoma who joined the interview group.

Find a Clinic Near You

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials
377
Recruited
95,900+

Lustgarten Foundation

Collaborator

Trials
27
Recruited
5,500+

Findings from Research

A study involving 27 patients with pancreatic ductal adenocarcinoma showed that structured radiology reports significantly improved the completeness of preoperative CT staging by capturing more morphological and vascular features compared to conventional free-text reports.
The use of structured reports enhanced inter-reader agreement on key vascular features, indicating that this reporting method can lead to more consistent and reliable staging of pancreatic cancer.
Impact of structured report on the quality of preoperative CT staging of pancreatic ductal adenocarcinoma: assessment of intra- and inter-reader variability.Dimarco, M., Cannella, R., Pellegrino, S., et al.[2021]
The Animated Pancreas Patient (APP) educational modules reached over 4.5 million views globally, with 60% of unique visitors from the U.S., indicating a strong interest in pancreatic cancer education among patients, families, and healthcare providers.
The most viewed content included topics like 'Understanding Clinical Trials,' suggesting that these resources effectively enhance health literacy and understanding of pancreatic cancer, which may lead to better health outcomes.
Helping Patients Understand Pancreatic Cancer Using Animated Pancreas Patient Education With Visual Formats of Learning.Munigala, S., Gardner, TB., O'Reilly, EM., et al.[2023]
A survey of 43 abdominal radiologists revealed that while 86% use structured reporting templates, only 60.5% utilize PDAC-specific templates, despite recognizing their benefits for accuracy and uniformity.
Dynamic multiphasic pancreatic protocol CT is the most commonly performed imaging study for diagnosing and staging pancreatic ductal adenocarcinoma (PDAC), with 92.7% of respondents employing this method.
Multi-institutional survey on imaging practice patterns in pancreatic ductal adenocarcinoma.Kambadakone, AR., Zaheer, A., Le, O., et al.[2023]

References

Impact of structured report on the quality of preoperative CT staging of pancreatic ductal adenocarcinoma: assessment of intra- and inter-reader variability. [2021]
Helping Patients Understand Pancreatic Cancer Using Animated Pancreas Patient Education With Visual Formats of Learning. [2023]
Multi-institutional survey on imaging practice patterns in pancreatic ductal adenocarcinoma. [2023]
Structured reporting of multiphasic CT for pancreatic cancer: potential effect on staging and surgical planning. [2022]
Disparities in Diagnostic Imaging for Initial Local Staging for Rectal Cancer. [2023]
Multidetector CT evaluation of the course of nonresectable pancreatic carcinomas with neoadjuvant therapy. [2016]
Characterization of pancreatic tumor motion using cine MRI: surrogates for tumor position should be used with caution. [2021]
Considerable interobserver variation in delineation of pancreatic cancer on 3DCT and 4DCT: a multi-institutional study. [2022]
An innovative strategy for the identification and 3D reconstruction of pancreatic cancer from CT images. [2018]
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