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A Decision Support Tool for Pancreatic Cancer Screening -Aim 2

1. September 2026 aktualisiert von: UNC Lineberger Comprehensive Cancer Center
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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

40

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • North Carolina
      • Chapel Hill, North Carolina, Vereinigte Staaten, 27599
        • University of North Carolina at Chapel Hill, Department of Gastroenterology and Hepatology
        • Kontakt:
          • Trevor Barlowe, MD
        • Hauptermittler:
          • Trevor Barlowe, MD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Electronic Decision Support Tool
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.
Verhalten: 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.
Kein Eingriff: Standard of Care
Patients eligible for pancreatic cancer screening will receive usual clinical care without use of the electronic decision support tool.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Acceptability of the decision support tool
Zeitfenster: 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").
Up to 3 months
Feasibility, Barriers, and Facilitators of Implementing the Decision Support Tool - Recruitment Rate
Zeitfenster: 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.
Up to 3 months
Feasibility, barriers, and facilitators of implementing the decision support tool - retention rate
Zeitfenster: 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.
Up to 3 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in score on 5 question knowledge assessment
Zeitfenster: 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.
Up to 3 months
Rate of Decision-Concordant Care
Zeitfenster: 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
Up to 3 months
Duration of the clinic visit
Zeitfenster: 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.
Up to 3 months
Patient-reported assessment of shared decision-making quality -1
Zeitfenster: 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.
Up to 3 months
Patient-reported assessment of shared decision-making quality -2
Zeitfenster: 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.
Up to 3 months
Patient-reported assessment of decisional conflict
Zeitfenster: 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.
Up to 3 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Mitarbeiter

National Center for Advancing Translational Sciences (NCATS)

Ermittler

  • Hauptermittler: Trevor Barlowe, MD, UNC Lineberger Comprehensive Cancer Center

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

8. September 2026

Primärer Abschluss (Geschätzt)

8. September 2027

Studienabschluss (Geschätzt)

8. September 2027

Studienanmeldedaten

Zuerst eingereicht

25. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. September 2026

Zuerst gepostet (Tatsächlich)

9. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 25-3036AIM2
  • K12TR004416 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

De-identified individual participant data (IPD) underlying published results will be made available to qualified researchers upon reasonable request, beginning one year after publication.

IPD-Sharing-Zeitrahmen

One year after publication

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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