A Decision Support Tool for Pancreatic Cancer Screening -Aim 2

NCT07808671 | Not Yet Recruiting DMC

• 2 other identifiers: 25-3036AIM2K12TR004416
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (3)

• 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").

  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.

  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.

  Up to 3 months

Secondary Outcomes (6)

• Change in score on 5 question knowledge assessment

  Up to 3 months

• Rate of Decision-Concordant Care

  Up to 3 months

• Duration of the clinic visit

  Up to 3 months

• Patient-reported assessment of shared decision-making quality -1

  Up to 3 months

• Patient-reported assessment of shared decision-making quality -2

  Up to 3 months

Study Arms (2)

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.

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.

Interventions

Electronic Decision Support Tool BEHAVIORAL

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.

Electronic Decision Support Tool

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill, Department of Gastroenterology and Hepatology

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Trevor Barlowe, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trevor Barlowe, MD

CONTACT

919-984-0000; trevor_barlowe@med.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: block randomization with 3:1 allocation will be used at the time of consent.

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: September 9, 2026
• Study Start: September 8, 2026
• Primary Completion (Estimated): September 8, 2027
• Study Completion (Estimated): September 8, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: One year after publication

Locations

US (1)