Early Detection of Cancer
Conditions
Keywords
Cancer screening, multi-cancer early screening, decision making, informational preferences, randomized clinical trial
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.
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.
Interventions
BEHAVIORALTest 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.
BEHAVIORALTest 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.
BEHAVIORALDiagnostic 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.
BEHAVIORALDiagnostic 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.
BEHAVIORALTest 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.
BEHAVIORALTest 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.
Sponsors
Trustees of Dartmouth College
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 74 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decisional Conflict | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Screening Intentions | 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). |
| Informed Subscale of the Decisional Conflict Scale | 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). |
| Uncertainty Subscale of the Decisional Conflict Scale | 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). |
Countries
United States
Contacts
CONTACTChristine M Gunn, PhD
Outcome results
None listed