Understanding Information Preferences, Risk Perceptions, and Tradeoffs When Making Decisions About Multi-cancer Early Detection Tests
26 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
- Comportemental: Test Performance Information: High Detail
- Comportemental: Diagnostic Workup Information: High Detail
- Comportemental: Test and Workup Cost Information: High Detail
- Comportemental: Test and Workup Cost Information: Low Detail
- Comportemental: Diagnostic Workup Information: Low Detail
- Comportemental: Test Performance Information: Low Detail
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
3000
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Christine M Gunn, PhD
- Numéro de téléphone: 603-646-5430
- E-mail: Christine.M.Gunn@dartmouth.edu
Lieux d'étude
-
-
New Hampshire
-
Lebanon, New Hampshire, États-Unis, 03756
- Dartmouth College
-
Contact:
- Christine M Gunn, PhD
- Numéro de téléphone: 603-646-5430
- E-mail: Christine.M.Gunn@dartmouth.edu
-
Contact:
- Laura B Beidler, MPH
- Numéro de téléphone: 603-646-5611
- E-mail: laura.beidler@dartmouth.edu
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Decisional Conflict
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Screening Intentions
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 septembre 2027
Achèvement primaire (Estimé)
1 juillet 2028
Achèvement de l'étude (Estimé)
1 juillet 2029
Dates d'inscription aux études
Première soumission
14 août 2026
Première soumission répondant aux critères de contrôle qualité
26 août 2026
Première publication (Réel)
28 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
28 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- STUDY00033796
- 1R01CA317672 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
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.
Délai de partage IPD
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.
Critères d'accès au partage IPD
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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .