GC-PRO Intervention

NCT06671704 | Completed

• 1 other identifier: CBS-2024-33212
• Study Type: interventional
• Target: 1,094
• Locations: 1 country
• Sites: 1

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

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

Keywords

genetic counseling; cancer; heart disease; reproductive; prenatal; genetic

Outcome Measures

Primary Outcomes (1)

• effectiveness of a genetic counseling skills training intervention

  The exact measure of effectiveness has been omitted to ensure no bias is created and that research integrity is preserved

  1 month

Secondary Outcomes (8)

• patient perception of overall GC quality

  1 month

• patient-centered communication

  1 month

• patient empowerment

  1 month

• patient activation

  1 month

• patient information needs met / information overload

  1 month

Study Arms (6)

Cluster 1

EXPERIMENTAL

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

Other: Genetic counseling months 4-15

Cluster 2

EXPERIMENTAL

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

Other: Genetic counseling months 6-15

Cluster 3

EXPERIMENTAL

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

Other: Genetic counseling months 8-15

Cluster 4

EXPERIMENTAL

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

Other: Genetic counseling at months 10-15

Cluster 5

EXPERIMENTAL

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

Other: Genetic counseling at months 12-15

Cluster 6

EXPERIMENTAL

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

Other: Genetic counseling at months 14-15

Interventions

Genetic counseling months 4-15 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 1

Genetic counseling months 6-15 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 2

Genetic counseling months 8-15 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 3

Genetic counseling at months 10-15 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 4

Genetic counseling at months 12-15 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 5

Genetic counseling at months 14-15 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.

Cluster 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead
• University of South Florida: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Neoplasms; Cardiovascular Diseases; Genetic Diseases, Inborn; Heart Diseases

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Heather Zierhut

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped wedge randomized controlled trial

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: November 4, 2024
• Study Start: January 3, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (1)