A Decision Support Tool for Pancreatic Cancer Screening -Aim 2
1 september 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
40
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Trevor Barlowe, MD
- Telefonnummer: 919-984-0000
- E-post: trevor_barlowe@med.unc.edu
Studieorter
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North Carolina
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Chapel Hill, North Carolina, Förenta staterna, 27599
- University of North Carolina at Chapel Hill, Department of Gastroenterology and Hepatology
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Kontakt:
- Trevor Barlowe, MD
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Huvudutredare:
- Trevor Barlowe, MD
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Inget ingripande: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Acceptability of the decision support tool
Tidsram: 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
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in score on 5 question knowledge assessment
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Trevor Barlowe, MD, UNC Lineberger Comprehensive Cancer Center
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
8 september 2026
Primärt slutförande (Beräknad)
8 september 2027
Avslutad studie (Beräknad)
8 september 2027
Studieregistreringsdatum
Först inskickad
25 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
1 september 2026
Första postat (Faktisk)
9 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
1 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 25-3036AIM2
- K12TR004416 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
De-identified individual participant data (IPD) underlying published results will be made available to qualified researchers upon reasonable request, beginning one year after publication.
Tidsram för IPD-delning
One year after publication
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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