A Decision Support Tool for Pancreatic Cancer Screening -Aim 2
1 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
40
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Trevor Barlowe, MD
- Numéro de téléphone: 919-984-0000
- E-mail: trevor_barlowe@med.unc.edu
Lieux d'étude
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27599
- University of North Carolina at Chapel Hill, Department of Gastroenterology and Hepatology
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Contact:
- Trevor Barlowe, MD
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Chercheur principal:
- Trevor Barlowe, MD
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
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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.
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Aucune intervention: Standard of Care
Patients eligible for pancreatic cancer screening will receive usual clinical care without use of the electronic decision support tool.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Acceptability of the decision support tool
Délai: Up to 3 months
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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").
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Up to 3 months
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Feasibility, Barriers, and Facilitators of Implementing the Decision Support Tool - Recruitment Rate
Délai: Up to 3 months
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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.
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Up to 3 months
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Feasibility, barriers, and facilitators of implementing the decision support tool - retention rate
Délai: Up to 3 months
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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.
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Up to 3 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in score on 5 question knowledge assessment
Délai: Up to 3 months
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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.
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Up to 3 months
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Rate of Decision-Concordant Care
Délai: Up to 3 months
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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
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Up to 3 months
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Duration of the clinic visit
Délai: Up to 3 months
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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.
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Up to 3 months
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Patient-reported assessment of shared decision-making quality -1
Délai: Up to 3 months
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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.
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Up to 3 months
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Patient-reported assessment of shared decision-making quality -2
Délai: Up to 3 months
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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.
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Up to 3 months
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Patient-reported assessment of decisional conflict
Délai: Up to 3 months
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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.
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Up to 3 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Les enquêteurs
- Chercheur principal: Trevor Barlowe, MD, UNC Lineberger Comprehensive Cancer Center
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
8 septembre 2026
Achèvement primaire (Estimé)
8 septembre 2027
Achèvement de l'étude (Estimé)
8 septembre 2027
Dates d'inscription aux études
Première soumission
25 août 2026
Première soumission répondant aux critères de contrôle qualité
1 septembre 2026
Première publication (Réel)
9 septembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
9 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
1 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 25-3036AIM2
- K12TR004416 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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Description du régime IPD
De-identified individual participant data (IPD) underlying published results will be made available to qualified researchers upon reasonable request, beginning one year after publication.
Délai de partage IPD
One year after publication
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .