Mobile App for Pancreatic Cancer

(PROCLAIM Trial)

Recruiting at 1 trial location

Overseen By Maddy Ledenyi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Dementia, Psychiatric condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

26 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on using a mobile app to increase involvement in clinical trial discussions for Black individuals with pancreatic cancer. The app facilitates conversations between patients and their care team about joining clinical trials. By tailoring the app to cultural needs, researchers aim to empower more Black patients to participate in these discussions, addressing a current gap in trial participation. This trial specifically targets Black individuals diagnosed with pancreatic cancer who can engage in a one-hour interview. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance communication and participation in clinical trials for Black patients.

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 prior data suggests that this mobile app is safe for use in clinical trial discussions?

Research has shown that digital health tools, like mobile apps, can be safe and helpful for patients. For example, E-health tools that allow patients to report their feelings have encouraged participation in cancer care. This enables patients to easily share their emotions, helping them receive necessary support.

One study found that supportive apps with patient interaction offer important benefits. These tools are user-friendly and effective. Nurses have also reported positive experiences using these systems, suggesting they can provide personalized care.

While these studies don't specifically test the safety of this mobile app, they demonstrate that similar tools are generally safe and beneficial. This app aims to help Black pancreatic cancer patients engage in clinical trial discussions, drawing insights from these digital health tools. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how a mobile app can enhance the engagement of pancreatic cancer patients with their computed tomography (CT) scans. Unlike traditional treatments like chemotherapy or targeted drug therapy, this approach uses technology to potentially improve the patient experience and engagement with their ongoing care. By promoting better communication and understanding through the app, researchers hope to empower patients with more information and support, which could lead to improved outcomes and satisfaction with their treatment process.

What evidence suggests that this mobile app is effective for increasing clinical trial participation among Black pancreatic cancer patients?

Research has shown that mobile apps can help patients manage their health and stay organized, potentially improving communication with their doctors. These tools have increased involvement in various health situations, suggesting benefits for pancreatic cancer patients. In this trial, participants will join either the Interview Group or the User Testing Group. A mobile app designed specifically for Black pancreatic cancer patients could help overcome obstacles to joining clinical trials. By improving communication and offering culturally relevant information, this app aims to encourage patients to discuss clinical trials more with their healthcare team. Early evidence in similar areas suggests that digital tools can empower patients to take an active role in their healthcare decisions. ^{6 7 8 9 10}

Who Is on the Research Team?

Jen J. Yeh

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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

I have been diagnosed with pancreatic cancer.

Identify as Black

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: User Testing Group Experimental Treatment 1 Intervention

Subjects with pancreatic carcinoma who joined the user testing group

Group II: Interview Group Experimental Treatment 1 Intervention

Subjects with pancreatic carcinoma who joined the interview group.

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Multidetector CT (MD-CT) demonstrated 100% sensitivity in assessing the irresectability of nonresectable pancreatic carcinoma in a study of 26 patients, making it a reliable imaging tool during therapy.

After treatment, 54% of tumors showed a decrease in size, while the invasion score (IS) indicated significant changes in vascular invasion, highlighting MD-CT's effectiveness in monitoring tumor progression and vascular involvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidetector CT evaluation of the course of nonresectable pancreatic carcinomas with neoadjuvant therapy. Klauss, M., Alt, CD., Welzel, T., et al.[2016]

Structured reporting of multiphasic CT scans for pancreatic cancer staging included significantly more key features (10.6) compared to nonstructured reports (7.3), enhancing the clarity and completeness of the information provided for surgical planning.

Surgeons were more confident in assessing tumor resectability when using structured reports, leading to a higher likelihood of definitive decisions compared to nonstructured reports, indicating that structured reporting improves the evaluation process for pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Structured reporting of multiphasic CT for pancreatic cancer: potential effect on staging and surgical planning. Brook, OR., Brook, A., Vollmer, CM., et al.[2022]

In a study of 346 rectal cancer patients, 26.8% did not receive initial staging imaging (MRI or endoscopic ultrasound), highlighting a significant gap in care.

Demographic factors such as Hispanic ethnicity, Medicaid or no insurance, and low-income residency were linked to lower rates of receiving timely imaging, indicating disparities in access to quality care for rectal cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disparities in Diagnostic Imaging for Initial Local Staging for Rectal Cancer. Lo, A., Le, B., Colin-Escobar, J., et al.[2023]

In a study of 17 patients with unresectable pancreatic cancer, it was found that pancreatic tumors move significantly more than previously anticipated during respiration, necessitating larger margins (up to 20 mm) for effective radiotherapy coverage.

The study revealed that tumor motion does not correlate well with the movement of the diaphragm or abdominal wall, indicating that current motion management strategies may be inadequate and could lead to underdosing the tumor and overdosing surrounding healthy tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of pancreatic tumor motion using cine MRI: surrogates for tumor position should be used with caution. Feng, M., Balter, JM., Normolle, D., et al.[2021]

There is significant interobserver variation in delineating pancreatic tumors, with the largest discrepancies observed in 4DCT imaging compared to 3DCT, indicating challenges in consistent tumor identification.

The internal gross tumor volume (iGTV) was generally larger than the gross tumor volume (GTV) due to accounting for respiratory motion, but this also led to greater observer variation, particularly near biliary stents and enlarged lymph nodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Considerable interobserver variation in delineation of pancreatic cancer on 3DCT and 4DCT: a multi-institutional study. Versteijne, E., Gurney-Champion, OJ., van der Horst, A., et al.[2022]

An innovative tool for 3D reconstruction of Pancreatic Ductal AdenoCarcinoma from Multi-Detector-Computed Tomography has been developed, allowing for clear differentiation between tumor mass and healthy tissue.

In a preliminary evaluation of ten cases, the tool demonstrated high effectiveness, with expert radiologists accepting the 3D reconstructions without modification in 70% of cases, indicating its potential for accurate tumor visualization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An innovative strategy for the identification and 3D reconstruction of pancreatic cancer from CT images. Marconi, S., Pugliese, L., Del Chiaro, M., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-institutional survey on imaging practice patterns in pancreatic ductal adenocarcinoma. Kambadakone, AR., Zaheer, A., Le, O., et al.[2023]

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