Genetic Counseling for Inherited Disorders

Overseen By Elena Fisher

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Unable to provide consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

994 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to improve genetic counseling by exploring methods to enhance patient experiences. Participants will complete two surveys and allow audio recordings of their genetic counseling sessions. The study focuses on benefiting underserved communities, including Somali, Latino/Hispanic, Black/African American, and Hmong groups. Potential participants include those referred to genetic counseling for hereditary cancer, heart conditions, or reproductive issues, who can communicate in English. The trial includes the GC-PRO Intervention, designed to enhance the genetic counseling process. As an unphased trial, it offers participants the opportunity to contribute to improving genetic counseling methods for diverse communities.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems unlikely that you would need to stop, as the study focuses on genetic counseling rather than medication use.

What prior data suggests that this genetic counseling method is safe?

Research has shown that genetic counseling is generally safe. Most studies have found it helps people understand their genetic risks without causing harm. A few negative outcomes have occurred, typically when unqualified individuals provide the counseling. When trained professionals conduct genetic counseling, it is usually well-received. Participants in past studies did not report any major problems. Therefore, if considering joining a study that includes genetic counseling, the risks are usually low. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GC-PRO intervention because it offers a fresh approach to genetic counseling for inherited disorders. Unlike traditional methods that may involve basic counseling at diagnosis, this intervention emphasizes a structured and timed transition from standard care to comprehensive genetic counseling over specific intervals. This allows for more personalized and targeted support throughout the patient's journey. The hope is that this tailored approach will lead to better understanding and management of the condition, empowering patients with critical knowledge about their genetic risks and options.

What evidence suggests that this trial's genetic counseling methods could be effective?

Research has shown that genetic counseling can greatly improve patient outcomes. Studies have found that it enhances patient experiences, reduces worry, and increases understanding of inherited disorders. In this trial, participants will be randomized into different clusters to transition from standard care to genetic counseling at various times. These benefits appear in people from various backgrounds, making genetic counseling a promising option for many. Effective communication plays a key role in these positive results. Overall, genetic counseling has demonstrated clear benefits for those dealing with inherited disorders. ^{1 2 3 4 6}

Who Is on the Research Team?

Heather Zierhut

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

The GC-PRO study is for adults 18 or older who, or whose child, have been referred for genetic counseling due to a family/personal history of hereditary cancer, heart issues, general genetic conditions, or reproductive concerns. Participants must understand English to complete forms and surveys.

Inclusion Criteria

Understand and be able to provide information for study forms and surveys in English.

I or my child have been referred for genetic counseling due to a family history of hereditary conditions.

Exclusion Criteria

For pediatric genetic counseling referrals, individuals who are not the parent or legal guardian of the child will be excluded from participating.

I am unable to understand and give consent for treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Genetic Counseling Intervention

Participants receive genetic counseling and complete two surveys, with audio recording of the session

1 month

1 visit (in-person)

Follow-up

Participants are monitored for outcomes such as patient empowerment, activation, and perception of genetic counseling quality

1 month

What Are the Treatments Tested in This Trial?

Interventions

• GC-PRO Intervention

Trial Overview

This trial aims to improve genetic counseling experiences by comparing different approaches over several months (4-15). Participants will fill out two surveys and have their counseling sessions recorded. The study focuses on inclusivity across diverse communities.

How Is the Trial Designed?

Group I: Cluster 6 Experimental Treatment 1 Intervention

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

Group II: Cluster 5 Experimental Treatment 1 Intervention

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

Group III: Cluster 4 Experimental Treatment 1 Intervention

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

Group IV: Cluster 3 Experimental Treatment 1 Intervention

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

Group V: Cluster 2 Experimental Treatment 1 Intervention

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

Group VI: Cluster 1 Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

University of South Florida

Collaborator

Trials

433

Recruited

198,000+

Published Research Related to This Trial

Pre-test genetic counseling significantly reduced worry and increased knowledge about genetic risks, but it did not have a notable impact on anxiety, depression, or the intent to pursue genetic testing, based on a systematic review of 25 studies.

The evidence regarding the overall effectiveness of genetic counseling in improving health outcomes, such as cancer prevention behaviors and accurate risk assessment, is of very low quality, indicating a need for further research to establish its true impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic evidence review and meta-analysis of outcomes associated with cancer genetic counseling. Culver, JO., Bertsch, NL., Kurz, RN., et al.[2023]

Genetic counseling (GC) is a vital communication process that addresses the human issues arising from genetic diseases, emphasizing the need for health professionals to understand and manage the psychological impacts on families.

The review highlights a gap in current practices, where technical aspects of genetics overshadow the emotional and adaptive responses of families, suggesting a need for more humanized care and non-directive psychological techniques in GC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic counseling. Pina-Neto, JM.[2020]

Genetic counseling is a comprehensive process that supports individuals from the initial referral through diagnosis and treatment options, ensuring they understand their genetic information and its implications.

The goal of genetic counseling is to empower individuals to make informed decisions about their health and reproductive choices by providing clear communication and support throughout the process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic counseling. Herrmann, J., Opitz, JM.[2019]

The introduction of a Genetic Counselor (GC)-mandate policy did not lead to an increase in the completion of genetic testing for cancer susceptibility genes (BRCA1 and BRCA2) or in the identification of mutations, indicating that the policy may not enhance patient outcomes.

Low-income individuals faced greater barriers to completing genetic testing, often due to insurance issues and time constraints, suggesting that the GC-mandate policy may inadvertently limit access to testing for those at higher risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a genetic counseling requirement prior to genetic testing. Stenehjem, DD., Au, T., Sainski, AM., et al.[2019]

The National Society of Genetic Counselors (NSGC) has developed 23 consensus standards for reporting genetic counseling interventions to enhance the rigor and clarity of research in this field.

Adopting these Genetic Counseling Intervention Reporting Standards (GCIRS) is recommended for authors and journals to improve the quality and applicability of genetic counseling studies in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standards for the Reporting of Genetic Counseling Interventions in Research and Other Studies (GCIRS): an NSGC Task Force Report. Hooker, GW., Babu, D., Myers, MF., et al.[2018]

A study of 307 patients at a psychiatric genetic counseling clinic found that genetic counseling significantly improved patient outcomes, as indicated by a large increase in Genetic Counseling Outcome Scale (GCOS) scores after sessions.

The effectiveness of genetic counseling was influenced by factors such as the mode of delivery (in-person, telephone, or telehealth) and the primary reason for the appointment, with those starting with lower GCOS scores showing the most benefit, suggesting potential for targeted referrals based on initial scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationships between patient- and session-related variables and outcomes of psychiatric genetic counseling. Gerrard, S., Inglis, A., Morris, E., et al.[2021]

The Genomics Outcome Scale (GOS), a shorter version of the Genetic Counseling Outcome Scale (GCOS-24), effectively measures patient empowerment in genetic counseling, showing significant improvements in scores after clinic attendance among 138 respondents.

The GOS demonstrated good sensitivity to change with a medium-to-large effect size (Cohen's d = 0.73), indicating that genetic counseling services provide measurable benefits to patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing sensitivity to change of the genomics outcome scale (GOS). Ting, MSO., Clarke, A., McAllister, M.[2022]

Genetic counselors in Minnesota reported 37 incidents where patients experienced negative outcomes due to genetics services provided by non-genetics providers, highlighting issues like psychosocial effects and medical mismanagement.

To prevent these negative outcomes, counselors suggested strategies such as educational outreach for healthcare providers, standardized testing processes, and better reporting mechanisms for adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What's the harm? Genetic counselor perceptions of adverse effects of genetics service provision by non-genetics professionals. Bensend, TA., Veach, PM., Niendorf, KB.[2022]

A concise genetic counseling summary letter (1.5 pages) was rated more positively by parents compared to a longer narrative format (4-5 pages), particularly in terms of emotional response, indicating it may help reduce anxiety and improve coping after a new diagnosis.

Parents with diverse educational backgrounds found the shorter letter format more accessible and useful, suggesting that genetic counselors should consider using simplified communication strategies to enhance understanding and emotional support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Long and Short of Genetic Counseling Summary Letters: A Case-control Study. Roggenbuck, J., Temme, R., Pond, D., et al.[2018]

The National Society of Genetic Counselors (NSGC) has defined genetic counseling as a comprehensive process that helps individuals understand and adapt to the implications of genetic factors in diseases, focusing on medical, psychological, and familial aspects.

This definition emphasizes the importance of interpreting family and medical histories, educating patients about genetics, and providing counseling to support informed decision-making and adaptation to genetic risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new definition of Genetic Counseling: National Society of Genetic Counselors' Task Force report. Resta, R., Biesecker, BB., Bennett, RL., et al.[2022]

Genetic counselors prioritize meeting clients' needs through education and psychosocial support, while clients often enter sessions without clear expectations, leading to a positive surprise when counseling occurs.

Both clients and counselors agree that successful genetic counseling is marked by strong interpersonal connections, with clients valuing the time spent and the clear, comprehensive information provided, which enhances communication with family members.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Goals, benefits, and outcomes of genetic counseling: client and genetic counselor assessment. Bernhardt, BA., Biesecker, BB., Mastromarino, CL.[2019]

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Genetic Counseling for Inherited Disorders

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The objective of the Genetic Counseling Processes Result in Outcomes (GC-PRO) study is to characterize GC communication skills using a novel and pragmatic ...

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sciencedirect.com/science/article/pii/S1098360023009966

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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 ...