GC-PRO Intervention

Not Applicable

Recruiting

• Conditions: Cancer; Cardiovascular Diseases; Prenatal Condition; Reproductive Condition; Genetic Condition

• Registration Number: NCT06671704
• Lead Sponsor: University of Minnesota

Brief Summary

The goal of the GC-PRO study is to try to make genetic counseling better for people of all backgrounds. We are asking participants to complete two surveys and to allow audio recording of their genetic counseling visit. The purpose of the study is to understand whether trying different ways of doing genetic counseling will lead to better experiences for patients. The research team is also working with partners from the Somali, Latino/Hispanic, Black/African American, and Hmong communities to make sure the research is being done in a way that will benefit underserved communities.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-21
• Study First Submitted QC: 2024-10-31
• Study First Posted: 2024-11-04
• Status Verified: 2025-01
• Study Start: 2025-01-03
• Last Update Submitted: 2025-01-04
• Last Update Posted: 2025-01-07
• Primary Completion: 2026-03-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 994

Inclusion Criteria

• Aged 18 years or older
• individual OR their child has been referred to genetic counseling for family and/or personal history of hereditary cancer, cardiology condition, general genetics indication, or reproductive/prenatal indication at a participating study site
• understand and be able to provide information for study forms and surveys in English.

Exclusion Criteria

• Unable to provide informed consent
• For pediatric genetic counseling referrals, individuals who are not the parent or legal guardian of the child will be excluded from participating.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
effectiveness of a genetic counseling skills training intervention	1 month	The exact measure of effectiveness has been omitted to ensure no bias is created and that research integrity is preserved

Secondary Outcome Measures

Name	Time	Method
patient perception of overall GC quality	1 month	Overall perception of quality of the genetic counseling session
patient-centered communication	1 month	An assessment of the patient's experience with their healthcare provider
patient empowerment	1 month	A process through which patients gain control over decisions and actions affecting their health
patient activation	1 month	A patient's ability to manage their own health and take an active role in their care
patient information needs met / information overload	1 month	Assessment of how much information the patient desired and was provided
patients' perceived trust in GC	1 month	Measure of patients' trust in their provider
working alliance	1 month	Relationship between patient and provider
GC verbal dominance	1 month	Measurement of the amount of time the patient, genetic counselor, and other individuals spend talking in the session

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States