Genetic Counseling for Breast Cancer

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Overseen ByThe Ohio State University Comprehensive Cancer Center
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Ohio State University Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of genetic counseling for women at higher risk of breast cancer. One group will receive a new form of counseling through educational videos via the MyChart patient portal, known as the Genetic Counseling Patient Preference Intervention. The other group will receive traditional in-person counseling, referred to as Conventional Genetic Counseling. The trial aims to determine if the video-based approach is as effective in helping women understand their risk and make informed decisions. Women who are patients at Ohio State University, use MyChart, and are undergoing routine breast cancer screening may be eligible to participate. This trial could lead to more accessible and personalized genetic counseling options in the future. As an unphased trial, it offers a unique opportunity to contribute to innovative approaches in genetic counseling.

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 prior data suggests that this genetic counseling approach is safe?

Research has shown that genetic counseling is generally safe for patients. This counseling helps individuals understand their breast cancer risk based on genetic factors. Studies have found that tools like educational videos can simplify the process and may reduce stress related to genetic risk.

Regarding safety, no direct evidence indicates harm from these counseling methods. Genetic counseling is not a drug or physical treatment, so it lacks side effects typical of medications. Instead, it focuses on sharing information and supporting personal choices. The Genetic Counseling Patient Preference (GCPP) intervention, which uses videos instead of traditional face-to-face counseling, has not been shown to pose any additional risks.

Overall, genetic counseling—whether conducted in person or through the GCPP intervention—is well-received and can empower individuals with knowledge about their breast cancer risk.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to deliver genetic counseling for breast cancer patients. Unlike traditional genetic counseling, which involves in-person sessions, the Genetic Counseling Patient Preference (GCPP) intervention uses a series of educational videos to provide pre-genetic test information. This approach could make genetic counseling more accessible and convenient for patients, potentially leading to better understanding and engagement. By comparing this method with conventional counseling, researchers hope to find out if the video-based intervention can effectively meet patients' needs while also being more efficient.

What evidence suggests that this trial's genetic counseling interventions could be effective for breast cancer risk management?

Research has shown that genetic counseling helps people understand their breast cancer risk and receive personalized advice. In this trial, participants will join one of two arms. Arm I involves the Genetic Counseling Patient Preference (GCPP) program, which uses educational videos for counseling. This method aims to match the effectiveness of traditional face-to-face counseling, offered in Arm II as conventional genetic counseling. The goal is to increase genetic knowledge, provide an accurate risk assessment, and reduce breast cancer-related worry. Studies suggest that this video-based approach could make genetic counseling more accessible and convenient. It may also benefit healthcare systems by offering a flexible and patient-friendly option.12678

Who Is on the Research Team?

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Kevin Sweet, MS, LGC

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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.
See 4 more

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.
See 1 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (GCPP intervention)Experimental Treatment2 Interventions
Group II: Arm II (conventional genetic counseling)Active Control2 Interventions

Find a Clinic Near You

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+

Published Research Related to This Trial

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

Citations

Study Details | NCT05325151 | Genetic Counseling Patient ...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 ...
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/37661005/
Genetic counseling and testing for females at elevated risk for ...The objective of this 2-arm randomized controlled trial is to determine the efficacy of Know Your Risk (KYR), a genetic counseling patient preference ...
Genetic Counseling Patient Preference Intervention versus ...This early stage I trial compares a genetic counseling patient preference intervention to conventional genetic counseling for women at elevated risk for breast ...
Genetic Counseling Patient Preference Intervention via ...The study results may change how genetic counseling is delivered to women with elevated breast cancer risk and address the increasing burden on the genetic ...
Genetic Counseling Patient Preference Intervention via ...The study results may change how genetic counseling is delivered to women with elevated breast cancer risk and address the increasing burden on the genetic ...
Genetic counseling and testing for females at elevated risk for ...Genetic counseling and testing for females at elevated risk for breast cancer: Protocol for the randomized controlled trial of the Know Your Risk intervention.
Division of Cancer Control & Population Sciences - Grant DetailsPROJECT SUMMARY Women at elevated risk for breast cancer should complete genetic counseling and may require more frequent screening or additional tests ...
Implementing interventions to increase genetic testing for ...Pretest counseling is generally aimed at providing information about hereditary breast cancer and the risks associated with being heterozygous for a ...
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