Understanding Information Preferences, Risk Perceptions, and Tradeoffs When Making Decisions About Multi-cancer Early Detection Tests
26 sierpnia 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Warunki
Interwencja / Leczenie
- Behawioralne: Test Performance Information: High Detail
- Behawioralne: Diagnostic Workup Information: High Detail
- Behawioralne: Test and Workup Cost Information: High Detail
- Behawioralne: Test and Workup Cost Information: Low Detail
- Behawioralne: Diagnostic Workup Information: Low Detail
- Behawioralne: Test Performance Information: Low Detail
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
3000
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Christine M Gunn, PhD
- Numer telefonu: 603-646-5430
- E-mail: Christine.M.Gunn@dartmouth.edu
Lokalizacje studiów
-
-
New Hampshire
-
Lebanon, New Hampshire, Stany Zjednoczone, 03756
- Dartmouth College
-
Kontakt:
- Christine M Gunn, PhD
- Numer telefonu: 603-646-5430
- E-mail: Christine.M.Gunn@dartmouth.edu
-
Kontakt:
- Laura B Beidler, MPH
- Numer telefonu: 603-646-5611
- E-mail: laura.beidler@dartmouth.edu
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przypisanie czynnikowe
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Decisional Conflict
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Screening Intentions
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
1 września 2027
Zakończenie podstawowe (Szacowany)
1 lipca 2028
Ukończenie studiów (Szacowany)
1 lipca 2029
Daty rejestracji na studia
Pierwszy przesłany
14 sierpnia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
26 sierpnia 2026
Pierwszy wysłany (Rzeczywisty)
28 sierpnia 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
28 sierpnia 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
26 sierpnia 2026
Ostatnia weryfikacja
1 sierpnia 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- STUDY00033796
- 1R01CA317672 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu 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.
Ramy czasowe udostępniania 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.
Kryteria dostępu do udostępniania 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.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- ANALITYCZNY_KOD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .