Understanding Information Preferences, Risk Perceptions, and Tradeoffs When Making Decisions About Multi-cancer Early Detection Tests
26. August 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
- Verhalten: Test Performance Information: High Detail
- Verhalten: Diagnostic Workup Information: High Detail
- Verhalten: Test and Workup Cost Information: High Detail
- Verhalten: Test and Workup Cost Information: Low Detail
- Verhalten: Diagnostic Workup Information: Low Detail
- Verhalten: Test Performance Information: Low Detail
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
3000
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Christine M Gunn, PhD
- Telefonnummer: 603-646-5430
- E-Mail: Christine.M.Gunn@dartmouth.edu
Studienorte
-
-
New Hampshire
-
Lebanon, New Hampshire, Vereinigte Staaten, 03756
- Dartmouth College
-
Kontakt:
- Christine M Gunn, PhD
- Telefonnummer: 603-646-5430
- E-Mail: Christine.M.Gunn@dartmouth.edu
-
Kontakt:
- Laura B Beidler, MPH
- Telefonnummer: 603-646-5611
- E-Mail: laura.beidler@dartmouth.edu
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Fakultätszuweisung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Decisional Conflict
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Screening Intentions
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. September 2027
Primärer Abschluss (Geschätzt)
1. Juli 2028
Studienabschluss (Geschätzt)
1. Juli 2029
Studienanmeldedaten
Zuerst eingereicht
14. August 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
26. August 2026
Zuerst gepostet (Tatsächlich)
28. August 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
28. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
26. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- STUDY00033796
- 1R01CA317672 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
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-Sharing-Zeitrahmen
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-Sharing-Zugriffskriterien
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.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- ANALYTIC_CODE
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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