Using Visual Arrays to Support Understanding of Genetic Risk

NCT06994832 | Completed

• 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)

• Risk Accuracy

  closest approximation to risk percentage depicted in the visual array

  immediately after the intervention

Secondary Outcomes (2)

• Risk Perceptions

  baseline

• Communication Intent

  immediately after the intervention

Study Arms (2)

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

Visual Array BEHAVIORAL

Single side-by-side visual array

Visual Array

Narrative Visual Array BEHAVIORAL

Evolving narrative with sequential visual arrays

Narrative Visual Array

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
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Boston College: collaborator

Study Sites (1)

Boston College

Boston, Massachusetts, 02467, United States

Location

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

Study Officials

• Andrew A Dwyer, PhD

  Boston College

  PRINCIPAL INVESTIGATOR

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

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: February 18, 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)