Genetic Counseling for Breast Cancer

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Previous genetic counseling, Breast cancer, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 14 months

874 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Genetic Counseling for Breast Cancer?

Research suggests that genetic counseling and testing can play a crucial role in managing breast cancer risk, especially for those at higher risk. The 'Know Your Risk' intervention aims to make genetic counseling more accessible and efficient, potentially improving patient experiences and meeting clinical demands. Additionally, using pre-visit websites and question prompt sheets can enhance communication and patient participation during counseling sessions. ^{1 2 3 4 5}

Is genetic counseling for breast cancer safe for humans?

The research does not provide specific safety data for genetic counseling, but it is generally considered a safe process as it involves providing information and support rather than medical treatment. ^{1 2 3 6 7}

How does the Genetic Counseling Patient Preference Intervention for breast cancer differ from other treatments?

The Genetic Counseling Patient Preference Intervention, also known as the Know Your Risk (KYR) intervention, is unique because it uses a patient-driven approach to genetic counseling and testing, which can increase accessibility and improve patient experience compared to conventional methods. This intervention leverages technology, such as the EHR MyChart patient portal, to facilitate communication and tailor information to individual patient preferences, making it more efficient and scalable. ^{1 2 3 8 9}

What is the purpose of this trial?

This stage I clinical trial compares a genetic counseling patient preference (GCPP) intervention via EHR MyChart patient portal to conventional genetic counseling for women at elevated risk for breast cancer. Women at elevated breast cancer risk may be offered genetic counseling and genetic testing to further define whether they are at high risk (e.g. hereditary risk; BRCA mutation positive); moderate risk (e.g. risk based largely on family history and/or polygenic risk score) or average risk (e.g. general population). Genetic counseling may improve basic genetic knowledge, produce more accurate risk perceptions and tailor recommendations for greater perceived personal control regarding breast cancer risk. A single approach to genetic counseling may not fit the needs for all patients, and genetic counseling models that increase access to genetic testing and are more patient-centered may better serve patients. This trial may help researchers determine if a GCPP intervention can take the place of conventional genetic counseling, while being non-inferior in terms of adherence to screening recommendations, breast cancer genetic knowledge, accurate perception of risk, breast cancer-specific worry, and satisfaction with counseling compared to conventional genetic counseling. Study results will provide the efficacy for using a novel cancer genetic counseling approach via EHR MyChart patient portal that will be readily adaptable to other health care systems in the future, inform best practices, and reduce workforce burden.

Research Team

Kevin Sweet, MS, LGC

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for women aged 30-64 who are patients at Ohio State University, use the MyChart portal, and are undergoing routine mammography. They must be at elevated risk for breast cancer as determined by a specific tool but cannot have had previous genetic counseling or testing for cancer risk genes, nor a personal history of certain breast conditions or cancers.

Inclusion Criteria

Undergoing routine screening mammography

Provide consent

You have a normal breast imaging result.

Exclusion Criteria

I have a known genetic mutation linked to breast cancer.

I have undergone genetic counseling before.

I have had breast or ovarian cancer, LCIS, or breast hyperplasia before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the GCPP intervention or conventional genetic counseling, including educational videos and genetic test results

Up to 14 months

Regular virtual or in-person sessions as per patient preference

Follow-up

Participants are monitored for adherence to NCCN guidelines, breast cancer genetic knowledge, risk perception, and satisfaction with counseling

Up to 14 months

Treatment Details

Interventions

• Conventional Genetic Counseling
• Genetic Counseling Patient Preference Intervention

Trial Overview The study compares a new Genetic Counseling Patient Preference (GCPP) intervention delivered through an electronic health record portal to traditional in-person genetic counseling. It aims to see if GCPP can match conventional methods in terms of adherence to screening recommendations and patient satisfaction without increasing worry.

Participant Groups

Group I: Arm I (GCPP intervention) Experimental Treatment 2 Interventions

Patients receive GCPP intervention consisting of a series of educational videos on pre-genetic test information.

Group II: Arm II (conventional genetic counseling) Active Control 2 Interventions

Patients receive conventional genetic counseling.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The 'Know Your Risk' (KYR) intervention, a patient-driven approach to genetic counseling, is being tested in a study with 1000 women at elevated risk for breast cancer to see if it can improve adherence to recommended cancer screenings compared to traditional counseling methods.

If proven effective, the KYR intervention could enhance patient experiences, increase access to genetic counseling, and alleviate the burden on healthcare providers, potentially transforming the delivery of genetic counseling services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic counseling and testing for females at elevated risk for breast cancer: Protocol for the randomized controlled trial of the Know Your Risk intervention. Sweet, K., Reiter, PL., Schnell, PM., et al.[2023]

Counselees who used a pre-visit website and question prompt sheet (QPS) were able to communicate more assertively during their breast cancer genetic counseling visits, sharing their agenda and directing the conversation more effectively.

The use of the QPS led counselors to provide more specific information related to DNA testing, enhancing the relevance of the discussion without increasing the length of the visit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pre-visit website with question prompt sheet for counselees facilitates communication in the first consultation for breast cancer genetic counseling: findings from a randomized controlled trial. Albada, A., van Dulmen, S., Ausems, MG., et al.[2022]

A survey of 243 genetic counselors revealed that 93% use breast cancer risk prediction models in their practice, with the Tyrer-Cuzick model being the most commonly used (95%).

The primary reasons for using these models include determining surveillance levels and eligibility for breast MRI, while time consumption and navigation difficulties are the main barriers to their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of breast cancer risk prediction models by cancer genetic counselors in clinical practice predominantly in the United States. Park, MS., Weissman, SM., Postula, KJV., et al.[2022]

A study of 216 genetic counseling clients revealed significant differences in their background, needs, and expectations (BNE) based on the type of counseling sought, indicating that reproductive, adult-pediatric, and cancer genetic counseling clients have distinct concerns and interests.

The findings suggest that genetic counseling should be tailored to the specific needs of different patient groups, and the BNE Scale is a reliable tool for assessing these differences, supporting the need for comprehensive training in genetic counseling practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of the background, needs, and expectations of patients seeking genetic counseling services. Peters, KF., Petrill, SA.[2020]

In a study involving 51 women undergoing breast cancer genetic counseling, it was found that general risks were primarily communicated during initial visits, while specific risks were discussed later, indicating a structured approach to risk communication.

Despite counselors helping counselees understand the information, the way risks were presented (mostly numerically or qualitatively) did not significantly influence counselees' risk perception or satisfaction, suggesting a need for more personalized communication strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk communication in completed series of breast cancer genetic counseling visits. Pieterse, AH., van Dulmen, S., van Dijk, S., et al.[2022]

Among 488 young breast cancer survivors surveyed, 42.2% reported receiving genetic counseling, primarily to help their family's future health, highlighting the importance of familial considerations in seeking genetic services.

Barriers to receiving genetic counseling included a lack of recommendations from healthcare providers and issues with medical insurance coverage, indicating a need for improved awareness and education about genetic counseling options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and facilitators for utilization of genetic counseling and risk assessment services in young female breast cancer survivors. Anderson, B., McLosky, J., Wasilevich, E., et al.[2021]

iKNOW is the first evidence-based digital tool designed to provide personalized counseling for women in Germany with hereditary cancer risks, specifically targeting those with pathogenic gBRCA variants that increase breast and ovarian cancer risks.

The tool is built on five key design principles aimed at standardizing and personalizing the counseling process, ensuring data privacy, and facilitating user-friendly access to complex information, which could serve as a model for future digital innovations in personalized cancer medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paradigmatic Approach to Support Personalized Counseling With Digital Health (iKNOW). Speiser, D., Heibges, M., Besch, L., et al.[2023]

Genetic counseling significantly increased the rates of breast self-examination, clinical breast examination, and mammography among 293 women attending Cancer Family Clinics, indicating improved management of breast cancer risk (p < 0.001).

Despite increased screening rates, women under 35 faced limited access to screening, and there was no evidence that anxiety about breast cancer hindered the uptake of health surveillance methods, suggesting that genetic counseling positively influences risk management without increasing anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does genetic counseling have any impact on management of breast cancer risk? Watson, M., Kash, KM., Homewood, J., et al.[2018]

Cancer genetic counseling is evolving to include more abbreviated pretest counseling, allowing for quicker informed consent processes for patients.

Genetic information is increasingly being integrated into oncology care, influencing decisions on surgery and chemotherapy, while direct-to-consumer testing options empower individuals to manage their genetic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer Genetic Counseling-Current Practice and Future Challenges. Schienda, J., Stopfer, J.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Genetic counseling and testing for females at elevated risk for breast cancer: Protocol for the randomized controlled trial of the Know Your Risk intervention. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A pre-visit website with question prompt sheet for counselees facilitates communication in the first consultation for breast cancer genetic counseling: findings from a randomized controlled trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Utilization of breast cancer risk prediction models by cancer genetic counselors in clinical practice predominantly in the United States. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A comparison of the background, needs, and expectations of patients seeking genetic counseling services. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Risk communication in completed series of breast cancer genetic counseling visits. [2022]

6. Egypt pubmed.ncbi.nlm.nih.gov

Barriers and facilitators for utilization of genetic counseling and risk assessment services in young female breast cancer survivors. [2021]

7. Canada pubmed.ncbi.nlm.nih.gov

Paradigmatic Approach to Support Personalized Counseling With Digital Health (iKNOW). [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Does genetic counseling have any impact on management of breast cancer risk? [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Cancer Genetic Counseling-Current Practice and Future Challenges. [2022]