CancerNCT06671704
GC-PRO Intervention
A study testing Genetic counseling months 4-15, Genetic counseling months 6-15 and Genetic counseling months 8-15 in people with Cancer and Cardiovascular Diseases, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Cardiovascular Diseases, Prenatal Condition
- What is being tested?
- Genetic counseling months 4-15, Genetic counseling months 6-15 and Genetic counseling months 8-15
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,094 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
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
- Being tested
- Genetic counseling months 4-15, Genetic counseling months 6-15, Genetic counseling months 8-15, Genetic counseling at months 10-15, Genetic counseling at months 12-15
- Keywords
- genetic counseling, cancer, heart disease, reproductive, prenatal, genetic
- Medical subject headings
- Neoplasms, Cardiovascular Diseases, Genetic Diseases, Inborn, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic counseling months 4-15Other
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.
Genetic counseling months 6-15Other
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.
Genetic counseling months 8-15Other
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.
Genetic counseling at months 10-15Other
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.
Genetic counseling at months 12-15Other
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.
Genetic counseling at months 14-15Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Cluster 1 | Experimental | Patients recruited and randomized to transfer from standard of care to genetic counselling in months 4-15 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: Genetic counseling at months 14-15 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (8)
patient perception of overall GC quality
Overall perception of quality of the genetic counseling session
Measured: 1 month
patient-centered communication
An assessment of the patient's experience with their healthcare provider
Measured: 1 month
patient empowerment
A process through which patients gain control over decisions and actions affecting their health
Measured: 1 month
patient activation
A patient's ability to manage their own health and take an active role in their care
Measured: 1 month
patient information needs met / information overload
Assessment of how much information the patient desired and was provided
Measured: 1 month
patients' perceived trust in GC
Measure of patients' trust in their provider
Measured: 1 month
working alliance
Relationship between patient and provider
Measured: 1 month
GC verbal dominance
Measurement of the amount of time the patient, genetic counselor, and other individuals spend talking in the session
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start3 Jan 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped wedge randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,094 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Florida
- Responsible party
- Sponsor
- Investigators
- Heather Zierhut, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671704
- Sponsor's protocol ID
- CBS-2024-33212
- Status last verified
- Apr 2026
- First submitted
- 21 Oct 2024
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GC-PRO Intervention
- ClinicalTrials.gov ID
- NCT06671704
- Acronym / sponsor ID
- CBS-2024-33212
- Conditions
- Cancer, Cardiovascular Diseases, Prenatal Condition, Reproductive Condition, Genetic Condition
- Keywords
- genetic counseling, cancer, heart disease, reproductive, prenatal, genetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,094 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- University of South Florida
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
- Model description
- Stepped wedge randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Cluster 1 | Experimental | Other: Genetic counseling months 4-15Patients recruited and randomized to transfer from standard of care to genetic counselling in months 4-15 |
| Cluster 2 | Experimental | Other: Genetic counseling months 6-15Patients recruited and randomized to transfer from standard of care to genetic counselling in months 6-15 |
| Cluster 3 | Experimental | Other: Genetic counseling months 8-15Patients recruited and randomized to transfer from standard of care to genetic counselling in months 8-15 |
| Cluster 4 | Experimental | Other: Genetic counseling at months 10-15Patients recruited and randomized to transfer from standard of care to genetic counselling in months 10-15 |
| Cluster 5 | Experimental | Other: Genetic counseling at months 12-15Patients recruited and randomized to transfer from standard of care to genetic counselling in months 12-15 |
| Cluster 6 | Experimental | Other: Genetic counseling at months 14-15Patients recruited and randomized to transfer from standard of care to genetic counselling in months 14-15 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic counseling months 4-15all 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. | Other | Cluster 1 |
| Genetic counseling months 6-15all 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. | Other | Cluster 2 |
| Genetic counseling months 8-15all 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. | Other | Cluster 3 |
| Genetic counseling at months 10-15all 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. | Other | Cluster 4 |
| Genetic counseling at months 12-15all 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. | Other | Cluster 5 |
| Genetic counseling at months 14-15all 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. | Other | Cluster 6 |
Primary outcome
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
8 secondary outcomes
patient perception of overall GC quality
Time frame: 1 month
patient-centered communication
Time frame: 1 month
patient empowerment
Time frame: 1 month
patient activation
Time frame: 1 month
patient information needs met / information overload
Time frame: 1 month
patients' perceived trust in GC
Time frame: 1 month
working alliance
Time frame: 1 month
GC verbal dominance
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Zierhut principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genetic counseling months 4-15, Genetic counseling months 6-15 and Genetic counseling months 8-15 in people with Cancer and Cardiovascular Diseases, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effectiveness of a genetic counseling skills training intervention (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.