GC-PRO Intervention

University of Minnesota (UMN)

Status: Enrolling

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

Treatments: Other: Genetic counseling at months 10-15; Other: Genetic counseling months 4-15; Other: Genetic counseling months 8-15; Other: Genetic counseling at months 12-15; Other: Genetic counseling months 6-15; Other: Genetic counseling at months 14-15

Study type: Interventional

Funder types: Other

Identifiers

NCT06671704

CBS-2024-33212

Details and patient eligibility

About

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.

Enrollment: 994 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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994 participants in 6 patient groups

Cluster 1

Experimental group

Description:

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

Treatment:

Other: Genetic counseling months 4-15

Cluster 2

Experimental group

Description:

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

Treatment:

Other: Genetic counseling months 6-15

Cluster 3

Experimental group

Description:

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

Treatment:

Other: Genetic counseling months 8-15

Cluster 4

Experimental group

Description:

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

Treatment:

Other: Genetic counseling at months 10-15

Cluster 5

Experimental group

Description:

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

Treatment:

Other: Genetic counseling at months 12-15

Cluster 6

Experimental group

Description:

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

Treatment:

Other: Genetic counseling at months 14-15