Understanding Information Preferences, Risk Perceptions, and Tradeoffs When Making Decisions About Multi-cancer Early Detection Tests

August 26, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1: High, High, High
Behavioral: Test Performance Information: High Detail
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.
Behavioral: Diagnostic Workup Information: High Detail
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.
Behavioral: Test and Workup Cost Information: High Detail
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
Behavioral: Test Performance Information: High Detail
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.
Behavioral: Diagnostic Workup Information: High Detail
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.
Behavioral: Test and Workup Cost Information: Low Detail
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
Behavioral: Test Performance Information: High Detail
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.
Behavioral: Test and Workup Cost Information: Low Detail
The low numerical data will provide broad ranges of diagnostic costs, indicating what costs are covered by insurance, and which are not.
Behavioral: Diagnostic Workup Information: Low Detail
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
Behavioral: Test Performance Information: High Detail
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.
Behavioral: Test and Workup Cost Information: High Detail
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.
Behavioral: Diagnostic Workup Information: Low Detail
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
Behavioral: Diagnostic Workup Information: High Detail
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.
Behavioral: Test and Workup Cost Information: High Detail
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.
Behavioral: Test Performance Information: Low Detail
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
Behavioral: Test and Workup Cost Information: High Detail
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.
Behavioral: Diagnostic Workup Information: Low Detail
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.
Behavioral: Test Performance Information: Low Detail
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
Behavioral: Diagnostic Workup Information: High Detail
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.
Behavioral: Test and Workup Cost Information: Low Detail
The low numerical data will provide broad ranges of diagnostic costs, indicating what costs are covered by insurance, and which are not.
Behavioral: Test Performance Information: Low Detail
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
Behavioral: Test and Workup Cost Information: Low Detail
The low numerical data will provide broad ranges of diagnostic costs, indicating what costs are covered by insurance, and which are not.
Behavioral: Diagnostic Workup Information: Low Detail
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.
Behavioral: Test Performance Information: Low Detail
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Decisional Conflict
Time Frame: 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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Screening Intentions
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Trustees of Dartmouth College

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00033796
  • 1R01CA317672 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Time Frame

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 Access Criteria

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 Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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