Pancreas CancerNCT07808671
A Decision Support Tool for Pancreatic Cancer Screening -Aim 2
A study testing Electronic Decision Support Tool in people with Pancreas Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
Pancreatic cancer has a rising incidence and poor survival. Early detection in high-risk individuals may substantially improve outcomes. Although guidelines recommend screening for individuals with hereditary cancer syndromes or certain genetic variants, pancreatic cancer screening remains uncertain due to limited… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- Electronic Decision Support Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2026to 8 Sep 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults who are eligible for pancreatic cancer screening according to current National Comprehensive Cancer Network guidelines.
- Not currently enrolled in a pancreatic cancer screening program.
- Referred to or previously seen at the UNC High Risk GI Cancer Clinic.
- English-speaking.
- Able and willing to provide informed consent.
Who cannot join
- Currently enrolled in a pancreatic cancer screening program.
- Does not meet pancreatic cancer screening eligibility criteria according to National Comprehensive Cancer Network guidelines.
- Unable or unwilling to provide informed consent.
- Non-English speaking.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of North Carolina at Chapel Hill, Department of Gastroenterology and Hepatology
Chapel Hill, North Carolina, 27599
Trevor Barlowe, MD
Trevor Barlowe, MD
About this study
Pancreatic cancer has a rising incidence and poor survival. Early detection in high-risk individuals may substantially improve outcomes. Although guidelines recommend screening for individuals with hereditary cancer syndromes or certain genetic variants, pancreatic cancer screening remains uncertain due to limited evidence of mortality benefit, unclear screening strategies, potential harms, resource requirements, and low adherence. Shared decision-making between patients and providers is therefore essential, but no decision aid currently exists to support pancreatic cancer screening decisions. This record covers Aim 2, which will evaluate the acceptability, feasibility, and implementation of an electronic decision support tool designed to improve shared decision-making, value-concordant care, and screening adherence. The pilot study will also provide training in clinical trial methodology and support development toward an independent research career.
- Conditions
- Pancreas Cancer
- Being tested
- Electronic Decision Support Tool
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Decision Support ToolBehavioural
Participants will use an electronic decision support tool designed to facilitate shared decision-making about pancreatic cancer screening. The pilot study will evaluate the tool's acceptability, feasibility, and implementation in clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Electronic Decision Support Tool | Experimental | Patients eligible for pancreatic cancer screening will use an electronic decision support tool during clinical care to support shared decision-making regarding pancreatic cancer screening. Receives: Behavioral: Electronic Decision Support Tool |
| Standard of Care | No intervention | Patients eligible for pancreatic cancer screening will receive usual clinical care without use of the electronic decision support tool. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the decision support tool
Participant-reported acceptability of the electronic decision support tool, assessed using a validated acceptability measures: acceptability of intervention measure (AIM) and intervention appropriateness measure (IAM). The minimum score for both measures is 4 (all items rated "1 - Completely Disagree") and the maximum score is 20 (all items rated "5 - Completely Agree").
Measured: Up to 3 months
Feasibility, Barriers, and Facilitators of Implementing the Decision Support Tool - Recruitment Rate
Recruitment rate, defined as the proportion and number of eligible participants who enroll in the study, will be used to assess the feasibility of integrating and implementing the electronic decision support tool in clinical practice.
Measured: Up to 3 months
Feasibility, barriers, and facilitators of implementing the decision support tool - retention rate
Retention rate, defined as the number and proportion of enrolled participants who complete use of the electronic decision support tool and all study-related assessments, will be used to assess the feasibility of integrating and implementing the tool in clinical practice.
Measured: Up to 3 months
Secondary outcomes (6)
Change in score on 5 question knowledge assessment
Difference between participants' post-visit and pre-visit knowledge scores regarding the screening decision. Change in knowledge will be defined as the difference between participants' post-visit and pre-visit knowledge scores on a five-item knowledge assessment, calculated as the post-knowledge score minus the pre-knowledge score. Pre- and post-knowledge scores will be calculated by summing correct answers (equal to 1) and incorrect or incomplete responses (equal to 0). The assessment will be administered immediately before and after the clinic visit.
Measured: Up to 3 months
Rate of Decision-Concordant Care
If the participant undergoes the screening test documented during the clinic visit within 3 months of the visit, this will be considered decision-concordant care. The rate of decision concordant care will be equal to the number of participants who underwent decision-concordant care divided by the total number of participants in the study. Medical record/chart review will be used for measurements
Measured: Up to 3 months
Duration of the clinic visit
Duration of the clinic visit will be measured as the duration of the index clinic visit using available clinical or electronic medical record timestamps. This measure will be used to evaluate whether the intervention affects the amount of time required to complete the clinic visit.
Measured: Up to 3 months
Patient-reported assessment of shared decision-making quality -1
Patient-reported assessment of the quality of the shared decision-making process, including the extent to which patients received information about available options, understood the benefits and risks of those options, and had their preferences considered in the decision. It will be measured using the collaboRATE questionnaire, administered immediately following the clinic visit and using the 9-item Shared Decision-Making Questionnaire (SDM-Q-9). The SDM-Q-9 measures the extent to which patients perceive that key components of shared decision-making occurred during the clinical encounter. The minimum score for the SDM-Q-9 is 0 (all items rated "0 - Completely Disagree") and the maximum score is 45 (all items rated "5 - Completely Agree"). Higher scores indicate a patient perception of better shared decision making. It will be administered immediately following the clinic visit.
Measured: Up to 3 months
Patient-reported assessment of shared decision-making quality -2
Patient-reported perception of the extent to which shared decision-making occurred during the clinic visit will be additionally be assessed using the 3 question collaboRATE questionnaire. The collaboRATE questionnaire measures the extent to which patients received information about available options, understood the benefits and risks of those options, and had their preferences considered. The minimum score for collaborate is 0 (all items rated "0 - No Effort") and the maximum score is 12 (all items rated "4 - Every Effort"). T the collaboRATE questionnaire will be administered immediately following the clinic visit.
Measured: Up to 3 months
Patient-reported assessment of decisional conflict
Patient-reported uncertainty or conflict regarding the screening decision, including factors such as informed choice, will be assessed using the 16 question decisional Conflict Scale (DCS). The minimum score for the DCS is 0 (no decisional conflict) and the maximum score is 100 (extremely high decisional conflict). The DCS will be administered immediately following the clinic visit.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start8 Dec 2026 (estimated)
- Primary completion8 Sep 2027 (estimated)
- Study completion8 Sep 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- block randomization with 3:1 allocation will be used at the time of consent.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Trevor Barlowe, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808671
- Sponsor's protocol ID
- 25-3036AIM2
- Other IDs
- K12TR004416
- Status last verified
- Nov 2026
- First submitted
- 25 Aug 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying published results will be made available to qualified researchers upon reasonable request, beginning one year after publication.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Decision Support Tool for Pancreatic Cancer Screening -Aim 2
- ClinicalTrials.gov ID
- NCT07808671
- Acronym / sponsor ID
- 25-3036AIM2
- Conditions
- Pancreas Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 8 Dec 2026 (estimated)
- Primary completion
- 8 Sep 2027 (estimated)
- Study completion
- 8 Sep 2027 (estimated)
- First posted
- 9 Sep 2026 (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.
Pancreatic cancer has a rising incidence and poor survival. Early detection in high-risk individuals may substantially improve outcomes. Although guidelines recommend screening for individuals with hereditary cancer syndromes or certain genetic variants, pancreatic cancer screening remains uncertain due to limited evidence of mortality benefit, unclear screening strategies, potential harms, resource requirements, and low adherence. Shared decision-making between patients and providers is therefore essential, but no decision aid currently exists to support pancreatic cancer screening decisions. This record covers Aim 2, which will evaluate the acceptability, feasibility, and implementation of an electronic decision support tool designed to improve shared decision-making, value-concordant care, and screening adherence. The pilot study will also provide training in clinical trial methodology and support development toward an independent research career.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- block randomization with 3:1 allocation will be used at the time of consent.
| Arm | Type | Receives |
|---|---|---|
| Electronic Decision Support Tool | Experimental | Behavioral: Electronic Decision Support ToolPatients eligible for pancreatic cancer screening will use an electronic decision support tool during clinical care to support shared decision-making regarding pancreatic cancer screening. |
| Standard of Care | No intervention | –Patients eligible for pancreatic cancer screening will receive usual clinical care without use of the electronic decision support tool. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults who are eligible for pancreatic cancer screening according to current National Comprehensive Cancer Network guidelines.
- Not currently enrolled in a pancreatic cancer screening program.
- Referred to or previously seen at the UNC High Risk GI Cancer Clinic.
- English-speaking.
- Able and willing to provide informed consent.
Key exclusion criteria (4 listed)
- Currently enrolled in a pancreatic cancer screening program.
- Does not meet pancreatic cancer screening eligibility criteria according to National Comprehensive Cancer Network guidelines.
- Unable or unwilling to provide informed consent.
- Non-English speaking.
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 |
|---|---|---|
| Electronic Decision Support ToolParticipants will use an electronic decision support tool designed to facilitate shared decision-making about pancreatic cancer screening. The pilot study will evaluate the tool's acceptability, feasibility, and implementation in clinical practice. | Behavioural | Electronic Decision Support Tool |
Primary outcome
Acceptability of the decision support tool
Time frame: Up to 3 months
Participant-reported acceptability of the electronic decision support tool, assessed using a validated acceptability measures: acceptability of intervention measure (AIM) and intervention appropriateness measure (IAM). The minimum score for both measures is 4 (all items rated "1 - Completely Disagree") and the maximum score is 20 (all items rated "5 - Completely Agree").
Feasibility, Barriers, and Facilitators of Implementing the Decision Support Tool - Recruitment Rate
Time frame: Up to 3 months
Recruitment rate, defined as the proportion and number of eligible participants who enroll in the study, will be used to assess the feasibility of integrating and implementing the electronic decision support tool in clinical practice.
Feasibility, barriers, and facilitators of implementing the decision support tool - retention rate
Time frame: Up to 3 months
Retention rate, defined as the number and proportion of enrolled participants who complete use of the electronic decision support tool and all study-related assessments, will be used to assess the feasibility of integrating and implementing the tool in clinical practice.
6 secondary outcomes
Change in score on 5 question knowledge assessment
Time frame: Up to 3 months
Rate of Decision-Concordant Care
Time frame: Up to 3 months
Duration of the clinic visit
Time frame: Up to 3 months
Patient-reported assessment of shared decision-making quality -1
Time frame: Up to 3 months
Patient-reported assessment of shared decision-making quality -2
Time frame: Up to 3 months
Patient-reported assessment of decisional conflict
Time frame: Up to 3 months
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 5 Nov 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying published results will be made available to qualified researchers upon reasonable request, beginning one year after publication.
Related trials for Pancreas Cancer
Recruiting
INtegrating Systematic PatIent-Reported Evaluations in Multi-Disciplinary Tumor Boards: The INSPIRE Study
Breast Cancer, Corpus Uteri Cancer
RecruitingPhase 1/2
A Study of GKL-006 Injection in Patients With Advanced Pancreatic Cancer
Advanced Pancreatic Cancer, Ductal Adenocarcinoma of Pancreas
Active, not recruitingPhase 1
Neoantigen Vaccines in Pancreatic Cancer in the Window Prior to Surgery
Pancreas Cancer, Pancreatic Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
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.
Trevor Barlowe, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Decision Support Tool in people with Pancreas Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site 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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Trevor Barlowe, MD (919-984-0000, trevor_barlowe@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the decision support tool (time frame: Up to 3 months). The study lists 3 primary outcomes in all. 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 5 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.