A Decision Support Tool for Pancreatic Cancer Screening -Aim 2

Brief summary public domain (ClinicalTrials.gov)

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.

Intervention public domain (ClinicalTrials.gov)

Behavioral: Electronic Decision Support Tool. 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.

Arm public domain (ClinicalTrials.gov)

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.

Arm public domain (ClinicalTrials.gov)

Standard of Care (no intervention): Patients eligible for pancreatic cancer screening will receive usual clinical care without use of the electronic decision support tool.

Primary outcome public domain (ClinicalTrials.gov)

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"). Time frame: Up to 3 months.

Primary outcome public domain (ClinicalTrials.gov)

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. Time frame: Up to 3 months.

Primary outcome public domain (ClinicalTrials.gov)

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. Time frame: Up to 3 months.

Secondary outcome public domain (ClinicalTrials.gov)

Change in score on 5 question knowledge assessment. Time frame: Up to 3 months.

Secondary outcome public domain (ClinicalTrials.gov)

Rate of Decision-Concordant Care. Time frame: Up to 3 months.

Secondary outcome public domain (ClinicalTrials.gov)

Duration of the clinic visit. Time frame: Up to 3 months.

Secondary outcome public domain (ClinicalTrials.gov)

Patient-reported assessment of shared decision-making quality -1. Time frame: Up to 3 months.

Secondary outcome public domain (ClinicalTrials.gov)

Patient-reported assessment of shared decision-making quality -2. Time frame: Up to 3 months.

Secondary outcome public domain (ClinicalTrials.gov)

Patient-reported assessment of decisional conflict. Time frame: Up to 3 months.

Eligibility public domain (ClinicalTrials.gov)

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 40 participants (estimated).