Pancreas CancerPROCLAIMNCT06252545
Promoting CT Engagement for Pancreatic Cancer With App
A study testing semistructured interviews and feedback in people with Pancreas Cancer, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- semistructured interviews and feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Feb 2024to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Lori Stravers, +1 919-966-4432, lori_stravers@med.unc.edu
Maddy Ledenyi, +1 919-843-4699, Madeleine_Ledenyi@med.unc.edu
- Recruiting
Medical College Of Wisconsin
Milwaukee, Wisconsin, 53226
Christian Campbell, +1 414-955-1423, ccampbell@mcw.edu
Ugwuji Maduekwe, MD, MMSc, MPH
About this study
Official title: PROmoting CLinicAl TrIal EngageMent for Pancreatic Cancer App Study (PROCLAIM Study
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.
Read more
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.
- Conditions
- Pancreas Cancer
- Being tested
- semistructured interviews, feedback
- Keywords
- ethnicity, black, application
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semistructured interviewsBehavioural
Black subjects with pancreatic cancer will provide insight on their experience discussing clinical trials and preferences for communicating clinical trial information
feedbackBehavioural
Black subjects with pancreatic cancer will provide feedback on mHealth app prototype.
| Study group | Role | What they receive |
|---|---|---|
| Interview Group | Other | Subjects with pancreatic carcinoma who joined the interview group. Receives: Behavioral: semistructured interviews |
| User Testing Group | Other | Subjects with pancreatic carcinoma who joined the user testing group Receives: Behavioral: feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start2 Feb 2024
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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..
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Lustgarten Foundation
- Responsible party
- Sponsor
- Investigators
- Ashwin J omasundaram, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252545
- Sponsor's protocol ID
- LCCC2234
- Acronym
- PROCLAIM
- Status last verified
- Sep 2026
- First submitted
- 1 Feb 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROmoting CLinicAl TrIal EngageMent for Pancreatic Cancer App Study (PROCLAIM Study
- ClinicalTrials.gov ID
- NCT06252545
- Acronym / sponsor ID
- PROCLAIM / LCCC2234
- Conditions
- Pancreas Cancer
- Keywords
- ethnicity, black, application
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Lustgarten Foundation
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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..
| Arm | Type | Receives |
|---|---|---|
| Interview Group | Other | Behavioral: semistructured interviewsSubjects with pancreatic carcinoma who joined the interview group. |
| User Testing Group | Other | Behavioral: feedbackSubjects with pancreatic carcinoma who joined the user testing group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| semistructured interviewsBlack subjects with pancreatic cancer will provide insight on their experience discussing clinical trials and preferences for communicating clinical trial information | Behavioural | Interview Group |
| feedbackBlack subjects with pancreatic cancer will provide feedback on mHealth app prototype. | Behavioural | User Testing Group |
Primary outcome
The clinical trial education and communication needs
Time frame: Up to 1 month
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashwin J omasundaram, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing semistructured interviews and feedback in people with Pancreas Cancer, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lori Stravers (1 919-966-4432, lori_stravers@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The clinical trial education and communication needs (time frame: Up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.