A Decision Support Tool for Pancreatic Cancer Screening -Aim 2
1 de setembro de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
40
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Trevor Barlowe, MD
- Número de telefone: 919-984-0000
- E-mail: trevor_barlowe@med.unc.edu
Locais de estudo
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- University of North Carolina at Chapel Hill, Department of Gastroenterology and Hepatology
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Contato:
- Trevor Barlowe, MD
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Investigador principal:
- Trevor Barlowe, MD
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
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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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Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Acceptability of the decision support tool
Prazo: 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
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in score on 5 question knowledge assessment
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Trevor Barlowe, MD, UNC Lineberger Comprehensive Cancer Center
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
8 de setembro de 2026
Conclusão Primária (Estimado)
8 de setembro de 2027
Conclusão do estudo (Estimado)
8 de setembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
25 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de setembro de 2026
Primeira postagem (Real)
9 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
9 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
1 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 25-3036AIM2
- K12TR004416 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Prazo de Compartilhamento de IPD
One year after publication
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .