A Decision Support Tool for Pancreatic Cancer Screening -Aim 2
2026年9月1日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
40
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Trevor Barlowe, MD
- 電話番号：919-984-0000
- メール：trevor_barlowe@med.unc.edu
研究場所
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North Carolina
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Chapel Hill、North Carolina、アメリカ、27599
- University of North Carolina at Chapel Hill, Department of Gastroenterology and Hepatology
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コンタクト：
- Trevor Barlowe, MD
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主任研究者：
- Trevor Barlowe, MD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Acceptability of the decision support tool
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in score on 5 question knowledge assessment
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Trevor Barlowe, MD、UNC Lineberger Comprehensive Cancer Center
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月8日
一次修了 (推定)
2027年9月8日
研究の完了 (推定)
2027年9月8日
試験登録日
最初に提出
2026年8月25日
QC基準を満たした最初の提出物
2026年9月1日
最初の投稿 (実際)
2026年9月9日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月9日
QC基準を満たした最後の更新が送信されました
2026年9月1日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 25-3036AIM2
- K12TR004416 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
One year after publication
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。