Overcoming Barriers to Uptake of Cascade Screening

NCT07304063 | Not Yet Recruiting DMC

• 2 other identifiers: LCCC2516-AIM2R21HG013417
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Lynch syndrome is a genetic condition that increases cancer risk. The public health impact of genetic testing for disease prevention hinges on cascade screening, which is the systematic identification and testing of blood relatives after a family member has been diagnosed with a genetic condition. Despite its importance in disease prevention, only half of first-degree relatives of individuals with Lynch syndrome undergo cascade screening. To address this gap, the study will pilot test an online version of Let's Talk, a novel intervention designed to support and promote cascade screening. This intervention tool is designed to support and encourage more family members to get screened. The purpose of this study aim is to assess the feasibility of the online Let's Talk tool in clinical use by examining implementation and effectiveness outcomes related to the use of the planning tool across three clinics at a large academic-affiliated medical center with patients (n=15) seen by one of five genetic counselors (n=5).

Conditions

Lynch Syndrome

Keywords

Screening; cascade screening

Outcome Measures

Primary Outcomes (1)

• Change in patient knowledge

  Change in patient knowledge will be measured by an online survey prior to and after the intervention. Knowledge will be measured using a 12-item knowledge scale developed by Bannon et al. (2014) covering topics such as hereditary basis of Lynch syndrome (LS), transmission pattern, risks of LS-related cancers, surveillance strategies, and prophylactic options. All items on the survey are of multiple-choice format and will be scored from 0-100% based on the proportion of correct answers. Change in patient knowledge across timepoints will be analyzed using a Wilcoxon signed rank test.

  2 months

Secondary Outcomes (5)

• Let's Talk reach

  8 months

• Let's Talk provider adoption

  8 months

• Let's Talk patient acceptability

  8 months

• Let's Talk provider feasibility

  8 months

• Let's Talk maintenance

  8 months

Study Arms (2)

Genetic Counselor participants

EXPERIMENTAL

Participants who are practicing genetic counselor at a medical institution.

Behavioral: Let's Talk Genetics Providers

Patient participants

EXPERIMENTAL

Participants who are with diagnosis of Lynch syndrome.

Behavioral: Let's Talk Patients

Interventions

Let's Talk Patients BEHAVIORAL

Patients will complete a brief pre-intervention survey and receive access to the online Let's Talk toolkit for two months. The toolkit addresses key barriers to cascade screening for Lynch syndrome by building knowledge, confidence, and communication skills through simple, evidence-based activities. After two months, patients will complete a post-intervention survey and participate in a qualitative interview.

Patient participants

Let's Talk Genetics Providers BEHAVIORAL

Providers will complete a brief pre-intervention survey and a short training on the Let's Talk tool. They will then help recruit eligible patients from genetics clinics who need cascade screening for Lynch syndrome. After the intervention, providers will complete post-intervention surveys and interviews.

Genetic Counselor participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent obtained to participate in the study.
• Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
• Age ≥ 18 years at the time of consent.
• Written informed consent obtained to participate in the study.
• Self-reported Lynch syndrome diagnosis.
• Written informed consent obtained to participate in the study.
• Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
• Age ≥ 18 years at the time of consent.
• Written informed consent obtained to participate in the study.
• Self-reported employment as a practicing genetic counselor at a medical institution.

You may not qualify if:

• The patient has already notified all relatives about their diagnosis with Lynch syndrome.
• Genetic Counselor is not employed.

Sponsors & Collaborators

• National Human Genome Research Institute (NHGRI): collaborator
• National Institutes of Health (NIH): collaborator
• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; 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

Study Officials

• Megan Roberts, PhD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Becca Bosch

CONTACT

919-984-0000; Rebecca_Bosch@med.unc.edu

Cason E Whitcomb

CONTACT

919-984-0000; Cason_Whitcomb@med.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 15 patients and 5 Genetic Counselor
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: December 26, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)