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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-74
SponsorTrustees of Dartmouth College

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 volunteers

Qualifiers

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

Design model

Factorial

Treatments tested in this trial

  • Test Performance Information: High Detail

    Behavioral

    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.

  • Test Performance Information: Low Detail

    Behavioral

    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.

  • Diagnostic Workup Information: High Detail

    Behavioral

    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.

  • Diagnostic Workup Information: Low Detail

    Behavioral

    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.

  • Test and Workup Cost Information: High Detail

    Behavioral

    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.

  • Test and Workup Cost Information: Low Detail

    Behavioral

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

Treatment groups

3,000 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Arm 1: High, High, HighExperimental treatment 3 interventions
Group B: Arm 2: High, High, LowExperimental treatment 3 interventions
Group C: Arm 3: High, Low, LowExperimental treatment 3 interventions
Group D: Arm 4: High, Low, HighExperimental treatment 3 interventions
Group E: Arm 5: Low, High, HighExperimental treatment 3 interventions
Group F: Arm 6: Low, Low, HighExperimental treatment 3 interventions
Group G: Arm 7: Low, High, LowExperimental treatment 3 interventions
Group H: Arm 8: Low, Low, LowExperimental treatment 3 interventions

Trial outcomes

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).

Time frame
24 hours

Secondary outcomes

1

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).

Time frame
24 hours
2

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).

Time frame
24 hours
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).

Time frame
24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Trustees of Dartmouth College

Lead sponsor

National Cancer Institute (NCI)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: