Understanding Information Preferences, Risk Perceptions, and Tradeoffs When Making Decisions About Multi-cancer Early Detection Tests
2026年8月26日 更新者：Christine M. Gunn、Trustees of Dartmouth College
Investigating Information Preferences, Risk Perceptions, and Tradeoffs in Multi-Cancer Early Detection Decisions: A Randomized Vignette Trial
The goal of this clinical trial is to learn what people's informational preferences and risk perceptions are in regards to the use of multi-cancer early detection (MCED) tests.
Participants will be asked to review three informational factors about MCED tests and complete a survey about their intentions to use an MCED test.
Some participants will also be asked to complete an interview.
調査の概要
状態
まだ募集していません
条件
詳細な説明
This is a clinical trial using a randomized vignette design where the vignette sequentially introduces 3 information factors to participants.
This allows for the effect of each informational factor to be tested in the context of the preceding sequence of factors.
In this study, the investigators will deliver the vignette in three phases, varying the level of detail of one factor in each phase, resulting in 8 combinations of study conditions.
Participants will be randomly assigned to these conditions and repeated measures of outcomes of interest will be derived from survey assessments conducted after each informational factor is presented.
At the end of trial participation, respondents will be invited to participate in one qualitative interview lasting 30-45 minutes.
研究の種類
介入
入学 (推定)
3000
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：Christine M Gunn, PhD
- 電話番号：603-646-5430
- メール：Christine.M.Gunn@dartmouth.edu
研究場所
-
-
New Hampshire
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Lebanon、New Hampshire、アメリカ、03756
- Dartmouth College
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コンタクト：
- Christine M Gunn, PhD
- 電話番号：603-646-5430
- メール：Christine.M.Gunn@dartmouth.edu
-
コンタクト：
- Laura B Beidler, MPH
- 電話番号：603-646-5611
- メール：laura.beidler@dartmouth.edu
-
-
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
いいえ
説明
Inclusion Criteria:
- Aged 40-74
- Speak English or Spanish
Exclusion Criteria:
- Prior diagnosis of cancer (with the exception of non-melanoma skin cancers)
- Previous use of a Multi-Cancer Early Detection (MCED) test.
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：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Arm 1: High, High, High
|
The test performance data presented in the vignette will focus on established evidentiary standards for the evaluation of screening tests: Sensitivity, specificity, positive and negative predictive values, and the ability of tests to find specific cancers and more early-stage cancers.
The high numerical detail condition will utilize these numbers and present them according to the decision aid criteria for presenting treatment option data and addressing health literacy.
The high numerical data will use diagnostic workup data from the most up-to-date findings at the time of survey fielding.
Data will be presented on the number of positive tests, follow up included (type and properties of tests), likelihood of receiving each type of test upon a positive findings, and data on median length of time to diagnostic resolution for both true positives and false positives.
Cost estimates will include insurance and out of pocket costs associated with various pathways of diagnostic workup.
The investigators will use test cost estimates based on market rates and insurance coverage mandates at the time of fielding the survey.
The high numerical data condition will provide precise estimates conditioned on level of workup and insurance coverage.
As above, the final content will be informed by new information that may be gleaned from ongoing studies.
|
|
実験的：Arm 2: High, High, Low
|
The test performance data presented in the vignette will focus on established evidentiary standards for the evaluation of screening tests: Sensitivity, specificity, positive and negative predictive values, and the ability of tests to find specific cancers and more early-stage cancers.
The high numerical detail condition will utilize these numbers and present them according to the decision aid criteria for presenting treatment option data and addressing health literacy.
The high numerical data will use diagnostic workup data from the most up-to-date findings at the time of survey fielding.
Data will be presented on the number of positive tests, follow up included (type and properties of tests), likelihood of receiving each type of test upon a positive findings, and data on median length of time to diagnostic resolution for both true positives and false positives.
The low numerical data will provide broad ranges of diagnostic costs, indicating what costs are covered by insurance, and which are not.
|
|
実験的：Arm 3: High, Low, Low
|
The test performance data presented in the vignette will focus on established evidentiary standards for the evaluation of screening tests: Sensitivity, specificity, positive and negative predictive values, and the ability of tests to find specific cancers and more early-stage cancers.
The high numerical detail condition will utilize these numbers and present them according to the decision aid criteria for presenting treatment option data and addressing health literacy.
The low numerical data will provide broad ranges of diagnostic costs, indicating what costs are covered by insurance, and which are not.
The low numerical detail condition will describe the possibility of further testing (more blood tests, imaging, and/or procedures) that may be required if the multi-cancer early detection (MCED) test has a positive finding, in line with prior studies communicating about MCED test workup.
|
|
実験的：Arm 4: High, Low, High
|
The test performance data presented in the vignette will focus on established evidentiary standards for the evaluation of screening tests: Sensitivity, specificity, positive and negative predictive values, and the ability of tests to find specific cancers and more early-stage cancers.
The high numerical detail condition will utilize these numbers and present them according to the decision aid criteria for presenting treatment option data and addressing health literacy.
Cost estimates will include insurance and out of pocket costs associated with various pathways of diagnostic workup.
The investigators will use test cost estimates based on market rates and insurance coverage mandates at the time of fielding the survey.
The high numerical data condition will provide precise estimates conditioned on level of workup and insurance coverage.
As above, the final content will be informed by new information that may be gleaned from ongoing studies.
The low numerical detail condition will describe the possibility of further testing (more blood tests, imaging, and/or procedures) that may be required if the multi-cancer early detection (MCED) test has a positive finding, in line with prior studies communicating about MCED test workup.
|
|
実験的：Arm 5: Low, High, High
|
The high numerical data will use diagnostic workup data from the most up-to-date findings at the time of survey fielding.
Data will be presented on the number of positive tests, follow up included (type and properties of tests), likelihood of receiving each type of test upon a positive findings, and data on median length of time to diagnostic resolution for both true positives and false positives.
Cost estimates will include insurance and out of pocket costs associated with various pathways of diagnostic workup.
The investigators will use test cost estimates based on market rates and insurance coverage mandates at the time of fielding the survey.
The high numerical data condition will provide precise estimates conditioned on level of workup and insurance coverage.
As above, the final content will be informed by new information that may be gleaned from ongoing studies.
The low numerical detail condition will describe the potential for false positives and use descriptions to denote qualitatively performance (high, acceptable, moderate, low).
The test performance data presented in the vignette will focus on established evidentiary standards for the evaluation of screening tests: Sensitivity, specificity, positive and negative predictive values, and the ability of tests to find specific cancers and more early-stage cancers.
|
|
実験的：Arm 6: Low, Low, High
|
Cost estimates will include insurance and out of pocket costs associated with various pathways of diagnostic workup.
The investigators will use test cost estimates based on market rates and insurance coverage mandates at the time of fielding the survey.
The high numerical data condition will provide precise estimates conditioned on level of workup and insurance coverage.
As above, the final content will be informed by new information that may be gleaned from ongoing studies.
The low numerical detail condition will describe the possibility of further testing (more blood tests, imaging, and/or procedures) that may be required if the multi-cancer early detection (MCED) test has a positive finding, in line with prior studies communicating about MCED test workup.
The low numerical detail condition will describe the potential for false positives and use descriptions to denote qualitatively performance (high, acceptable, moderate, low).
The test performance data presented in the vignette will focus on established evidentiary standards for the evaluation of screening tests: Sensitivity, specificity, positive and negative predictive values, and the ability of tests to find specific cancers and more early-stage cancers.
|
|
実験的：Arm 7: Low, High, Low
|
The high numerical data will use diagnostic workup data from the most up-to-date findings at the time of survey fielding.
Data will be presented on the number of positive tests, follow up included (type and properties of tests), likelihood of receiving each type of test upon a positive findings, and data on median length of time to diagnostic resolution for both true positives and false positives.
The low numerical data will provide broad ranges of diagnostic costs, indicating what costs are covered by insurance, and which are not.
The low numerical detail condition will describe the potential for false positives and use descriptions to denote qualitatively performance (high, acceptable, moderate, low).
The test performance data presented in the vignette will focus on established evidentiary standards for the evaluation of screening tests: Sensitivity, specificity, positive and negative predictive values, and the ability of tests to find specific cancers and more early-stage cancers.
|
|
実験的：Arm 8: Low, Low, Low
|
The low numerical data will provide broad ranges of diagnostic costs, indicating what costs are covered by insurance, and which are not.
The low numerical detail condition will describe the possibility of further testing (more blood tests, imaging, and/or procedures) that may be required if the multi-cancer early detection (MCED) test has a positive finding, in line with prior studies communicating about MCED test workup.
The low numerical detail condition will describe the potential for false positives and use descriptions to denote qualitatively performance (high, acceptable, moderate, low).
The test performance data presented in the vignette will focus on established evidentiary standards for the evaluation of screening tests: Sensitivity, specificity, positive and negative predictive values, and the ability of tests to find specific cancers and more early-stage cancers.
|
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 |
|---|---|---|
|
Decisional Conflict
時間枠：24 hours
|
A validated 10-item scale scored 0-100 that assesses decisional conflict using a 3-point Likert for each item; Includes 4 subscales: informed, uncertainty, values clarity, and support.
The full scale will be administered after the third vignette is presented (Time 3).
|
24 hours
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Screening Intentions
時間枠：24 hours
|
Validated 2 item measure including 1-item measuring intentions on 100 point scale and 1 decision question (yes/no/unsure).
This will be assessed at the end of each vignette (Time 1, 2, 3).
|
24 hours
|
|
Informed Subscale of the Decisional Conflict Scale
時間枠：24 hours
|
3 Items from the Decisional Conflict Scale will measure how informed participants feel about available options for MCED testing, benefits of MCED testing, and risks of MCED testing.
Each is rated on the 3-point scale (yes/no/unsure).
This will be assessed at the end of each vignette (Time 1, 2, 3).
|
24 hours
|
|
Uncertainty Subscale of the Decisional Conflict Scale
時間枠：24 hours
|
Two items from the Decisional Conflict Scale will measure uncertainty about the decision to use MCED tests.
This will include feeling clear about the best choice for the participant, and feeling sure about what to choose.
Each is rated on the 3-point scale (yes/no/unsure).
This will be assessed at the end of each vignette (Time 1, 2, 3).
|
24 hours
|
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。
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)
2027年9月1日
一次修了 (推定)
2028年7月1日
研究の完了 (推定)
2029年7月1日
試験登録日
最初に提出
2026年8月14日
QC基準を満たした最初の提出物
2026年8月26日
最初の投稿 (実際)
2026年8月28日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月28日
QC基準を満たした最後の更新が送信されました
2026年8月26日
最終確認日
2026年8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
- STUDY00033796
- 1R01CA317672 (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
Based on ethical considerations related to the protection of human subjects, the following data produced during the project will be preserved and shared:
- Survey responses
- Survey weights
- Qualitative interview data, deidentified and without any participant identifiers beyond assigned study group, state, and limited sociodemographic characteristics
The investigators will seek to share as much data as possible while maintaining a de-identified dataset without protected health information. Thus, the final shared data set will not include geographic subdivisions smaller than the state level, dates, birth dates, contact information, or other identification numbers.
Data available to be shared will be archived in the University of Michigan ICPSR data repository, which was chosen for its focus on social and behavioral data that align with the nature of data collected in this project.
IPD 共有時間枠
Data will be made available no later than time of an associated publication or end of the performance period, whichever comes first.
Data will be available for 5 years from the end of the study period.
IPD 共有アクセス基準
Requests for access to the data will be managed by the repository.
Requests will indicate intended use of the data, protections to be put in place to ensure secure data transfer, and to formulate a data use agreement, if applicable.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ANALYTIC_CODE
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。