Decision AidNCT06994832
Using Visual Arrays to Support Understanding of Genetic Risk
A study testing Visual Array, Narrative Visual Array and Choice in people with Decision Aid, run by Stephanie B. Seminara, MD at 1 site in United States.
Trial summary
The goal of this study is to understand how people understand risk from genetic testing. The investigators want to understand what visual aid best helps people accurately assess risk. The investigators also want to understand how people relate risk to their health. The main questions the study aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Decision Aid
- What is being tested?
- Visual Array, Narrative Visual Array and Choice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,045 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2025to 18 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ability to read and understand English
- opt-in consent
Who cannot join
- incorrect responses to validation questions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining Genetic Literacy and Numeracy in the General Population
The goal of this study is to understand how people understand risk from genetic testing. The investigators want to understand what visual aid best helps people accurately assess risk. The investigators also want to understand how people relate risk to their health. The main questions the study aims to answer are:
- Which visual aid most accurately show genetic risk?
- How do people perceive risk related to genetic test results?
- What factors are associated with people discussing their results with family?
Participants will:
- receive of of two visual aids showing risk
- state their estimation of risk
- answer questions about how they feel about risk and sharing information with family
Read the detailed description
This study aims to determine what visual aid helps people most accurately interpret risk from genetic test results. The study also examines how people perceive risk using the Tripartite Risk Model. Last, the study examines factors that are associated with intention to share genetic test results with family members.
Participants will provide brief sociodemographic information, complete brief health literacy and numeracy assessments, and questions about how they perceive risk. Participants will be informed of a genetic testing scenario and will receive one of two visual aids. After reviewing the visual aid, participants will state the risk shown in the visual aid and will answer questions about their perceived risk and sharing results with family members (blood relatives).
- Conditions
- Decision Aid
- Being tested
- Visual Array, Narrative Visual Array, Choice, Enhanced Choice
- Keywords
- Lynch syndrome, colorectal cancer, colon cancer, genetic testing
- Medical subject headings
- Colorectal Neoplasms, Hereditary Nonpolyposis, Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual ArrayBehavioural
Single side-by-side visual array
Narrative Visual ArrayBehavioural
Evolving narrative with sequential visual arrays
ChoiceBehavioural
Non-directive decision frame
Enhanced ChoiceBehavioural
Decision frame with subjective norms nudge
| Study group | Role | What they receive |
|---|---|---|
| Visual Array & Choice | Experimental | Single, side-by-side visual array and non-directive decision frame Receives: Behavioral: Visual Array; Behavioral: Choice |
| Visual Array and Enhanced Choice | Experimental | Single, side-by-side visual array and decision frame with subjective norms nudge Receives: Behavioral: Visual Array; Behavioral: Enhanced Choice |
| Narrative Visual Array and Choice | Experimental | Evolving narrative showing sequential visual arrays and non-directive decision frame Receives: Behavioral: Narrative Visual Array; Behavioral: Choice |
| Narrative Visual Array and Enhanced Choice | Experimental | Evolving narrative showing sequential visual arrays and decision frame with subjective norms nudge Receives: Behavioral: Narrative Visual Array; Behavioral: Enhanced Choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Overall Accuracy of General Population Risk for Colorectal Cancer Prior to Seeing Array
Differences between closest approximation to risk percentage depicted in the visual array that depicted risk with Lynch Syndrome (LS) minus risk without LS
Measured: immediately after the intervention
Secondary outcomes (5)
Accuracy of Risk for Colorectal Cancer for Someone Without Lynch Syndrome (Without Gene Mutation) From the Array
Percent (%) estimated colorectal cancer risk for people like the general population. Closest approximation to risk percentage depicted in the visual array.
Measured: immediately after the intervention
Accuracy of Risk for Colorectal Cancer for Someone With Lynch Syndrome From the Array
Percent (%) estimated colorectal cancer risk for people with Lynch Syndrome. Closest approximation to risk percentage depicted in the visual array showing the population of people with Lynch Syndrome
Measured: immediately after the intervention
Risk Perceptions - Percent
Percent (%) estimated own lifetime risk for getting colorectal cancer. Perceptions of deliberative risk using 0-100 scale.
Measured: baseline
Risk Perceptions - 7-point Likert-type Scale
Perceptions of affective and experiential risk using 7-point Likert-type scales
- Strongly agree
- Agree
- Somewhat agree
- Neither agree nor disagree
- Somewhat disagree
- Disagree
- Strongly disagree Higher scores indicate greater affective and experiential perceived personal colorectal cancer risk.
Measured: baseline
Communication Intent
Intent to communicate risk to blood relatives using 7-point Likert-type scale
- Extremely unlikely
- Unlikely
- Somewhat unlikely
- Neutral
- Somewhat likely
- Likely
- Extremely likely Higher scores indicate greater expressed likelihood of communicating genetic risk to family members.
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start28 Jul 2025
- Primary completion18 Aug 2025
- Study completion18 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Decision AidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One-to-one randomization into two parallel groups (Array Period); One-to-one randomization into two additional parallel groups (Family Communication Period)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,045 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephanie B. Seminara, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Boston College
- Responsible party
- Sponsor-investigator, Stephanie B. Seminara, MD, Massachusetts General Hospital
- Investigators
- Andrew A Dwyer, PhD, Principal investigator, Boston College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994832
- Sponsor's protocol ID
- 2025P000889
- Other IDs
- P50HD104224
- Status last verified
- Sep 2025
- First submitted
- 22 Apr 2025
- Last updated
- 24 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data will be shared via the HarvardDataverse platform.
Publications
Keels JN, Babicheva V, McDonald IR, Witt JK, Dwyer AA. Optimizing Risk Communication for Lynch Syndrome: Results of a Randomized Controlled Trial of Visual Arrays for Genetic Testing. Cancers (Basel). 2026 Apr 25;18(9):1369. doi: 10.3390/cancers18091369.
PubMed 42122165
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Genetic Literacy and Numeracy in the General Population
- ClinicalTrials.gov ID
- NCT06994832
- Acronym / sponsor ID
- 2025P000889
- Conditions
- Decision Aid
- Keywords
- Lynch syndrome, colorectal cancer, colon cancer, genetic testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,045 participants (actual)
- Lead sponsor
- Stephanie B. Seminara, MDUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Boston College
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 18 Aug 2025 (actual)
- Study completion
- 18 Aug 2025 (actual)
- First posted
- 29 May 2025 (actual)
- Results
- Posted 24 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to understand how people understand risk from genetic testing. The investigators want to understand what visual aid best helps people accurately assess risk. The investigators also want to understand how people relate risk to their health. The main questions the study aims to answer are:
- Which visual aid most accurately show genetic risk?
- How do people perceive risk related to genetic test results?
- What factors are associated with people discussing their results with family?
Participants will:
- receive of of two visual aids showing risk
- state their estimation of risk
- answer questions about how they feel about risk and sharing information with family
Detailed description
This study aims to determine what visual aid helps people most accurately interpret risk from genetic test results. The study also examines how people perceive risk using the Tripartite Risk Model. Last, the study examines factors that are associated with intention to share genetic test results with family members.
Participants will provide brief sociodemographic information, complete brief health literacy and numeracy assessments, and questions about how they perceive risk. Participants will be informed of a genetic testing scenario and will receive one of two visual aids. After reviewing the visual aid, participants will state the risk shown in the visual aid and will answer questions about their perceived risk and sharing results with family members (blood relatives).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- One-to-one randomization into two parallel groups (Array Period); One-to-one randomization into two additional parallel groups (Family Communication Period)
| Arm | Type | Receives |
|---|---|---|
| Visual Array & Choice | Experimental | Behavioral: Visual Array, Behavioral: ChoiceSingle, side-by-side visual array and non-directive decision frame |
| Visual Array and Enhanced Choice | Experimental | Behavioral: Visual Array, Behavioral: Enhanced ChoiceSingle, side-by-side visual array and decision frame with subjective norms nudge |
| Narrative Visual Array and Choice | Experimental | Behavioral: Narrative Visual Array, Behavioral: ChoiceEvolving narrative showing sequential visual arrays and non-directive decision frame |
| Narrative Visual Array and Enhanced Choice | Experimental | Behavioral: Narrative Visual Array, Behavioral: Enhanced ChoiceEvolving narrative showing sequential visual arrays and decision frame with subjective norms nudge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ability to read and understand English
- opt-in consent
Key exclusion criteria (1 listed)
- incorrect responses to validation questions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual ArraySingle side-by-side visual array | Behavioural | Visual Array & Choice, Visual Array and Enhanced Choice |
| Narrative Visual ArrayEvolving narrative with sequential visual arrays | Behavioural | Narrative Visual Array and Choice, Narrative Visual Array and Enhanced Choice |
| ChoiceNon-directive decision frame | Behavioural | Narrative Visual Array and Choice, Visual Array & Choice |
| Enhanced ChoiceDecision frame with subjective norms nudge | Behavioural | Narrative Visual Array and Enhanced Choice, Visual Array and Enhanced Choice |
Primary outcome
Perceived Overall Accuracy of General Population Risk for Colorectal Cancer Prior to Seeing Array
Time frame: immediately after the intervention
Differences between closest approximation to risk percentage depicted in the visual array that depicted risk with Lynch Syndrome (LS) minus risk without LS
5 secondary outcomes
Accuracy of Risk for Colorectal Cancer for Someone Without Lynch Syndrome (Without Gene Mutation) From the Array
Time frame: immediately after the intervention
Accuracy of Risk for Colorectal Cancer for Someone With Lynch Syndrome From the Array
Time frame: immediately after the intervention
Risk Perceptions - Percent
Time frame: baseline
Risk Perceptions - 7-point Likert-type Scale
Time frame: baseline
Communication Intent
Time frame: immediately after the intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42122165Keels JN, Babicheva V, McDonald IR, Witt JK, Dwyer AA. Optimizing Risk Communication for Lynch Syndrome: Results of a Randomized Controlled Trial of Visual Arrays for Genetic Testing. Cancers (Basel). 2026 Apr 25;18(9):1369. doi: 10.3390/cancers18091369.
- Individual participant dataSharing planned: Yes. Anonymized data will be shared via the HarvardDataverse platform.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew A Dwyer, PhD principal investigator
Boston College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual Array, Narrative Visual Array and Choice in people with Decision Aid, run by Stephanie B. Seminara, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Overall Accuracy of General Population Risk for Colorectal Cancer Prior to Seeing Array (time frame: immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06994832, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.