Using Visual Arrays to Support Understanding of Genetic Risk

NCT06994832 | Completed Results

• 2 other identifiers: 2025P000889P50HD104224
• Study Type: interventional
• Target: 1,045
• Locations: 1 country
• Sites: 1

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:

1. 1.Which visual aid most accurately show genetic risk?
2. 2.How do people perceive risk related to genetic test results?
3. 3.What factors are associated with people discussing their results with family?
4. 4.receive of of two visual aids showing risk
5. 5.state their estimation of risk
6. 6.answer questions about how they feel about risk and sharing information with family

Conditions

Decision Aid

Keywords

Lynch syndrome; colorectal cancer; colon cancer; genetic testing

Outcome Measures

Primary Outcomes (1)

• 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

  immediately after the intervention

Secondary Outcomes (5)

• Accuracy of Risk for Colorectal Cancer for Someone Without Lynch Syndrome (Without Gene Mutation) From the Array

  immediately after the intervention

• Accuracy of Risk for Colorectal Cancer for Someone With Lynch Syndrome From the Array

  immediately after the intervention

• Risk Perceptions - Percent

  baseline

• Risk Perceptions - 7-point Likert-type Scale

  baseline

• Communication Intent

  immediately after the intervention

Study Arms (4)

Visual Array & Choice

EXPERIMENTAL

Single, side-by-side visual array and non-directive decision frame

Behavioral: Visual Array; Behavioral: Choice

Visual Array and Enhanced Choice

EXPERIMENTAL

Single, side-by-side visual array and decision frame with subjective norms nudge

Behavioral: Visual Array; Behavioral: Enhanced Choice

Narrative Visual Array and Choice

EXPERIMENTAL

Evolving narrative showing sequential visual arrays and non-directive decision frame

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

Behavioral: Narrative Visual Array; Behavioral: Enhanced Choice

Interventions

Visual Array BEHAVIORAL

Single side-by-side visual array

Visual Array & Choice; Visual Array and Enhanced Choice

Narrative Visual Array BEHAVIORAL

Evolving narrative with sequential visual arrays

Narrative Visual Array and Choice; Narrative Visual Array and Enhanced Choice

Choice BEHAVIORAL

Non-directive decision frame

Narrative Visual Array and Choice; Visual Array & Choice

Enhanced Choice BEHAVIORAL

Decision frame with subjective norms nudge

Narrative Visual Array and Enhanced Choice; Visual Array and Enhanced Choice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ability to read and understand English
• opt-in consent

You may not qualify if:

• incorrect responses to validation questions

Sponsors & Collaborators

• Stephanie B. Seminara, MD: lead
• Boston College: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Boston College

Boston, Massachusetts, 02467, United States

Location

Related Publications (1)

• 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.

  PMID: 42122165 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis; Colorectal Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Rectal Diseases

Results Point of Contact

• Title: Stephanie Seminara
• Organization: Massachusetts General Hospital

MGHReproEndoResearch@mgb.org

617-726-1309

Study Officials

• Andrew A Dwyer, PhD

  Boston College

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine

Model Details: One-to-one randomization into two parallel groups (Array Period); One-to-one randomization into two additional parallel groups (Family Communication Period)

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 29, 2025
• Study Start: July 28, 2025
• Primary Completion: August 18, 2025
• Study Completion: August 18, 2025
• Last Updated: September 24, 2026
• Results First Posted: September 24, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Start date: within one month of the publication of study results. End date: one year after posting.
• Access Criteria: HarvardDataverse platform

Locations

US (1)