NCT06252545

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Feb 2024Feb 2027

First Submitted

Initial submission to the registry

February 1, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

February 2, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 9, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

3 years

First QC Date

February 1, 2024

Last Update Submit

May 9, 2025

Conditions

Pancreas Cancer

Keywords

ethnicityblackapplication

Outcome Measures

Primary Outcomes (1)

  • The clinical trial education and communication needs

    The 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

Study Arms (2)

Interview Group

OTHER

Subjects with pancreatic carcinoma who joined the interview group.

Behavioral: semistructured interviews

User Testing Group

OTHER

Subjects with pancreatic carcinoma who joined the user testing group

Behavioral: feedback

Interventions

semistructured interviewsBEHAVIORAL

Black subjects with pancreatic cancer will provide insight on their experience discussing clinical trials and preferences for communicating clinical trial information

Interview Group
feedbackBEHAVIORAL

Black subjects with pancreatic cancer will provide feedback on mHealth app prototype.

User Testing Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent obtained to participate in the study
  • years or older
  • English speaking
  • Able and willing to participate in a 1-hour interview
  • History of pancreatic cancer diagnosis
  • Identify as Black

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Medical College Of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Jen J Yeh, MD

    UNC Lineberger Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lori Stravers

CONTACT

1 919-966-4432lori_stravers@med.unc.edu

Maddy Ledenyi

CONTACT

(919) 843-4699Madeleine_Ledenyi@med.unc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: There will be 2 groups: 20 subjects with pancreas carcinoma for phone interviews and 6 for user testing the first version of the application..
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2024

First Posted

February 9, 2024

Study Start

February 2, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

May 13, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)