NCT07793539

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
22mo left

Started Sep 2027

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 28, 2026

Completed
1 year until next milestone

Study Start

First participant enrolled

September 1, 2027

Expected
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

August 28, 2026

Status Verified

August 1, 2026

Enrollment Period

10 months

First QC Date

August 14, 2026

Last Update Submit

August 26, 2026

Conditions

Keywords

Cancer screeningmulti-cancer early screeningdecision makinginformational preferencesrandomized clinical trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Screening Intentions

    24 hours

  • Informed Subscale of the Decisional Conflict Scale

    24 hours

  • Uncertainty Subscale of the Decisional Conflict Scale

    24 hours

Study Arms (8)

Arm 1: High, High, High

EXPERIMENTAL
Behavioral: Test Performance Information: High DetailBehavioral: Diagnostic Workup Information: High DetailBehavioral: Test and Workup Cost Information: High Detail

Arm 2: High, High, Low

EXPERIMENTAL
Behavioral: Test Performance Information: High DetailBehavioral: Diagnostic Workup Information: High DetailBehavioral: Test and Workup Cost Information: Low Detail

Arm 3: High, Low, Low

EXPERIMENTAL
Behavioral: Test Performance Information: High DetailBehavioral: Diagnostic Workup Information: Low DetailBehavioral: Test and Workup Cost Information: Low Detail

Arm 4: High, Low, High

EXPERIMENTAL
Behavioral: Test Performance Information: High DetailBehavioral: Diagnostic Workup Information: Low DetailBehavioral: Test and Workup Cost Information: High Detail

Arm 5: Low, High, High

EXPERIMENTAL
Behavioral: Test Performance Information: Low DetailBehavioral: Diagnostic Workup Information: High DetailBehavioral: Test and Workup Cost Information: High Detail

Arm 6: Low, Low, High

EXPERIMENTAL
Behavioral: Test Performance Information: Low DetailBehavioral: Diagnostic Workup Information: Low DetailBehavioral: Test and Workup Cost Information: High Detail

Arm 7: Low, High, Low

EXPERIMENTAL
Behavioral: Test Performance Information: Low DetailBehavioral: Diagnostic Workup Information: High DetailBehavioral: Test and Workup Cost Information: Low Detail

Arm 8: Low, Low, Low

EXPERIMENTAL
Behavioral: Test Performance Information: Low DetailBehavioral: Diagnostic Workup Information: Low DetailBehavioral: Test and Workup Cost Information: Low Detail

Interventions

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.

Arm 1: High, High, HighArm 2: High, High, LowArm 3: High, Low, LowArm 4: High, Low, High

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.

Arm 5: Low, High, HighArm 6: Low, Low, HighArm 7: Low, High, LowArm 8: Low, Low, 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.

Arm 1: High, High, HighArm 2: High, High, LowArm 5: Low, High, HighArm 7: Low, High, Low

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.

Arm 3: High, Low, LowArm 4: High, Low, HighArm 6: Low, Low, HighArm 8: Low, Low, Low

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.

Arm 1: High, High, HighArm 4: High, Low, HighArm 5: Low, High, HighArm 6: Low, Low, High

The low numerical data will provide broad ranges of diagnostic costs, indicating what costs are covered by insurance, and which are not.

Arm 2: High, High, LowArm 3: High, Low, LowArm 7: Low, High, LowArm 8: Low, Low, Low

Eligibility Criteria

Age40 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 40-74
  • Speak English or Spanish

You may not qualify if:

  • Prior diagnosis of cancer (with the exception of non-melanoma skin cancers)
  • Previous use of a Multi-Cancer Early Detection (MCED) test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth College

Lebanon, New Hampshire, 03756, United States

Location

Central Study Contacts

Christine M Gunn, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Health Policy and Clinical Practice

Study Record Dates

First Submitted

August 14, 2026

First Posted

August 28, 2026

Study Start (Estimated)

September 1, 2027

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2029

Last Updated

August 28, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
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.
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.

Locations