GC-PRO Intervention

NCT ID: NCT06671704

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 994 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-03
• Study Completion Date: 2026-06-30

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.

Conditions

Cancer; Cardiovascular Diseases; Prenatal Condition; Reproductive Condition; Genetic Condition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Cluster 1

Patients recruited and randomized to transfer from standard of care to genetic counselling in months 4-15

Group Type: EXPERIMENTAL

Genetic counseling months 4-15

Intervention Type: OTHER

all genetic counselors within the same specialty at the same site will cross over from standard of care to the intervention training starting at month 4 to month 15.

Cluster 2

Patients recruited and randomized to transfer from standard of care to genetic counselling in months 6-15

Group Type: EXPERIMENTAL

Genetic counseling months 6-15

Intervention Type: OTHER

all genetic counselors within the same specialty at the same site will cross over from standard of care to the intervention training starting at month 6 to month 15.

Cluster 3

Patients recruited and randomized to transfer from standard of care to genetic counselling in months 8-15

Group Type: EXPERIMENTAL

Genetic counseling months 8-15

Intervention Type: OTHER

all genetic counselors within the same specialty at the same site will cross over from standard of care to the intervention training starting at month 8 to month 15.

Cluster 4

Patients recruited and randomized to transfer from standard of care to genetic counselling in months 10-15

Group Type: EXPERIMENTAL

Genetic counseling at months 10-15

Intervention Type: OTHER

all genetic counselors within the same specialty at the same site will cross over from standard of care to the intervention training starting at month 10 to month 15.

Cluster 5

Patients recruited and randomized to transfer from standard of care to genetic counselling in months 12-15

Group Type: EXPERIMENTAL

Genetic counseling at months 12-15

Intervention Type: OTHER

all genetic counselors within the same specialty at the same site will cross over from standard of care to the intervention training starting at month 12 to month 15.

Cluster 6

Patients recruited and randomized to transfer from standard of care to genetic counselling in months 14-15

Group Type: EXPERIMENTAL

Genetic counseling at months 14-15

Intervention Type: OTHER

all genetic counselors within the same specialty at the same site will cross over from standard of care to the intervention training starting at month 14 to month 15.

Interventions

Genetic counseling months 4-15

all genetic counselors within the same specialty at the same site will cross over from standard of care to the intervention training starting at month 4 to month 15.

Intervention Type: OTHER

Genetic counseling months 6-15

all genetic counselors within the same specialty at the same site will cross over from standard of care to the intervention training starting at month 6 to month 15.

Intervention Type: OTHER

Genetic counseling months 8-15

all genetic counselors within the same specialty at the same site will cross over from standard of care to the intervention training starting at month 8 to month 15.

Intervention Type: OTHER

Genetic counseling at months 10-15

all genetic counselors within the same specialty at the same site will cross over from standard of care to the intervention training starting at month 10 to month 15.

Intervention Type: OTHER

Genetic counseling at months 12-15

all genetic counselors within the same specialty at the same site will cross over from standard of care to the intervention training starting at month 12 to month 15.

Intervention Type: OTHER

Genetic counseling at months 14-15

all genetic counselors within the same specialty at the same site will cross over from standard of care to the intervention training starting at month 14 to month 15.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of South Florida

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heather Zierhut

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elena Fisher

Role: CONTACT

fishe912@umn.edu

612-626-6743

Facility Contacts

Elena Fischer

Role: primary

fishe912@umn.ed

612-626-6743

Other Identifiers

CBS-2024-33212

Identifier Type: -

Identifier Source: org_study_id