Understanding Information Preferences, Risk Perceptions, and Tradeoffs When Making Decisions About Multi-cancer Early Detection Tests
keskiviikko 26. elokuuta 2026 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Ei vielä rekrytointia
Interventio / Hoito
- Käyttäytyminen: Test Performance Information: High Detail
- Käyttäytyminen: Diagnostic Workup Information: High Detail
- Käyttäytyminen: Test and Workup Cost Information: High Detail
- Käyttäytyminen: Test and Workup Cost Information: Low Detail
- Käyttäytyminen: Diagnostic Workup Information: Low Detail
- Käyttäytyminen: Test Performance Information: Low Detail
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
3000
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Christine M Gunn, PhD
- Puhelinnumero: 603-646-5430
- Sähköposti: Christine.M.Gunn@dartmouth.edu
Opiskelupaikat
-
-
New Hampshire
-
Lebanon, New Hampshire, Yhdysvallat, 03756
- Dartmouth College
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Ottaa yhteyttä:
- Christine M Gunn, PhD
- Puhelinnumero: 603-646-5430
- Sähköposti: Christine.M.Gunn@dartmouth.edu
-
Ottaa yhteyttä:
- Laura B Beidler, MPH
- Puhelinnumero: 603-646-5611
- Sähköposti: laura.beidler@dartmouth.edu
-
-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Terveyspalvelututkimus
- Jako: Satunnaistettu
- Inventiomalli: Tehtävätehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
|
|
Kokeellinen: 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.
|
|
Kokeellinen: 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.
|
|
Kokeellinen: 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.
|
|
Kokeellinen: 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.
|
|
Kokeellinen: 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.
|
|
Kokeellinen: 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.
|
|
Kokeellinen: 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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Decisional Conflict
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Screening Intentions
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Yhteistyökumppanit
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Keskiviikko 1. syyskuuta 2027
Ensisijainen valmistuminen (Arvioitu)
Lauantai 1. heinäkuuta 2028
Opintojen valmistuminen (Arvioitu)
Sunnuntai 1. heinäkuuta 2029
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Perjantai 14. elokuuta 2026
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Keskiviikko 26. elokuuta 2026
Ensimmäinen Lähetetty (Todellinen)
Perjantai 28. elokuuta 2026
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Perjantai 28. elokuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Keskiviikko 26. elokuuta 2026
Viimeksi vahvistettu
Lauantai 1. elokuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muut tutkimustunnusnumerot
- STUDY00033796
- 1R01CA317672 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
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-jaon aikakehys
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-jaon käyttöoikeuskriteerit
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-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- ANALYTIC_CODE
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Ei
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
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