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

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: Not yet recruiting
• Conditions: Early Detection of Cancer
• Intervention / Treatment: Behavioral: Test Performance Information: High Detail; Behavioral: Diagnostic Workup Information: High Detail; Behavioral: Test and Workup Cost Information: High Detail; Behavioral: Test and Workup Cost Information: Low Detail; Behavioral: Diagnostic Workup Information: Low Detail; Behavioral: Test Performance Information: Low Detail

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: Interventional
• Enrollment (Estimated): 3000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christine M Gunn, PhD; Phone Number: 603-646-5430; Email: Christine.M.Gunn@dartmouth.edu

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth College
      • Contact: Christine M Gunn, PhD; Phone Number: 603-646-5430; Email: Christine.M.Gunn@dartmouth.edu
      • Contact: Laura B Beidler, MPH; Phone Number: 603-646-5611; Email: laura.beidler@dartmouth.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Decisional Conflict	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

Outcome Measure	Measure Description	Time Frame
Screening Intentions	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	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	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

• Sponsor: Trustees of Dartmouth College
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2027
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: August 14, 2026
• First Submitted That Met QC Criteria: August 26, 2026
• First Posted (Actual): August 28, 2026

Study Record Updates

• Last Update Posted (Actual): August 28, 2026
• Last Update Submitted That Met QC Criteria: August 26, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: randomized clinical trial; decision making; Cancer screening; multi-cancer early screening; informational preferences
• Other Study ID 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