GC-PRO Intervention

April 2, 2026 updated by: University of Minnesota
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1094

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cluster 1
Patients recruited and randomized to transfer from standard of care to genetic counselling in months 4-15
Other: 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.
Experimental: Cluster 2
Patients recruited and randomized to transfer from standard of care to genetic counselling in months 6-15
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.
Experimental: Cluster 3
Patients recruited and randomized to transfer from standard of care to genetic counselling in months 8-15
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.
Experimental: Cluster 4
Patients recruited and randomized to transfer from standard of care to genetic counselling in months 10-15
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.
Experimental: Cluster 5
Patients recruited and randomized to transfer from standard of care to genetic counselling in months 12-15
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.
Experimental: Cluster 6
Patients recruited and randomized to transfer from standard of care to genetic counselling in months 14-15
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

University of South Florida

Investigators

  • Principal Investigator: Heather Zierhut, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2025

Primary Completion (Actual)

March 31, 2026

Study Completion (Actual)

March 31, 2026

Study Registration Dates

First Submitted

October 21, 2024

First Submitted That Met QC Criteria

October 31, 2024

First Posted (Actual)

November 4, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBS-2024-33212

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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