About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 40-74
Speak English or Spanish
Disqualifiers
Prior diagnosis of cancer (with the exception of non-melanoma skin cancers)
Previous use of a Multi-Cancer Early Detection (MCED) test.
Trial design
Factorial
Treatments tested in this trial
Test Performance Information: High Detail
BehavioralThe 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.
Test Performance Information: Low Detail
BehavioralThe 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.
Diagnostic Workup Information: High Detail
BehavioralThe 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.
Diagnostic Workup Information: Low Detail
BehavioralThe 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.
Test and Workup Cost Information: High Detail
BehavioralCost 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.
Test and Workup Cost Information: Low Detail
BehavioralThe low numerical data will provide broad ranges of diagnostic costs, indicating what costs are covered by insurance, and which are not.
Treatment groups
8
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
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).
Secondary outcomes
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).
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).
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).
Sponsors and contacts
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Trustees of Dartmouth College
Lead sponsor
National Cancer Institute (NCI)
Collaborator
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