Using Visual Arrays to Support Understanding of Genetic Risk | NCT06994832

Studies
Using Visual Arrays to Support Understanding of Genetic Risk

NCT06994832

Sponsor

Stephanie B. Seminara, MD

Status

Completed

Last Update Posted

Feb 18, 2026Actual

Enrollment

1,045Actual

Phase

Not Applicable

Conditions

Decision Aid

Interventions

Visual Array
Narrative Visual Array

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
P50HD104224	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 28, 2025Actual

Primary Completion Date

Aug 18, 2025Actual

Completion Date

Aug 18, 2025Actual

First Submitted Date

Apr 22, 2025

First Submission Date that Met QC Criteria

May 20, 2025

First Posted Date

May 29, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2026

Last Update Posted Date

Feb 18, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stephanie B. Seminara, MD, Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine, Massachusetts General HospitalSponsor-Investigator

Lead Sponsor

Stephanie B. Seminara, MDOTHER

Collaborators

Name	Class
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	NIH
Boston College	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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:

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,045Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Visual Array	Experimental	Single, side-by-side visual array	Behavioral: Visual Array
Narrative Visual Array	Experimental	Evolving narrative showing sequential visual arrays	Behavioral: Narrative Visual Array

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Visual Array	Behavioral	Single side-by-side visual array	Visual Array

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Risk Accuracy	closest approximation to risk percentage depicted in the visual array	immediately after the intervention

Secondary Outcomes

Measure	Description	Time Frame
Risk Perceptions	Perceptions of deliberative, affective, and experiential risk using 7-point Likert-type scales	baseline
Communication Intent	Intent to communicate risk to blood relatives using 7-point Likert-type scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ability to read and understand English
opt-in consent

Exclusion Criteria:

incorrect responses to validation questions

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrew A Dwyer, PhD	Boston College	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Boston College		Boston	Massachusetts	02467	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42122165	Derived	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.

ID	Term
D003123	Colorectal Neoplasms, Hereditary Nonpolyposis
D015179	Colorectal Neoplasms
D003110	Colonic Neoplasms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site