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NCT Number: NCT07808671

A Decision Support Tool for Pancreatic Cancer Screening -Aim 2

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Chapel Hill, North Carolina, 27599, United States

Location contact

Trevor Barlowe, MD

CONTACT

Trevor Barlowe, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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").

  2. 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.

  3. 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.

Secondary outcomes

  1. Change in score on 5 question knowledge assessment

    Time frame: Up to 3 months

    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.

  2. Rate of Decision-Concordant Care

    Time frame: Up to 3 months

    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

  3. Duration of the clinic visit

    Time frame: Up to 3 months

    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.

  4. Patient-reported assessment of shared decision-making quality -1

    Time frame: Up to 3 months

    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.

  5. Patient-reported assessment of shared decision-making quality -2

    Time frame: Up to 3 months

    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.

  6. Patient-reported assessment of decisional conflict

    Time frame: Up to 3 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Trevor Barlowe, MD

CONTACT

[email protected]

919-984-0000

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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