Genetic Counseling Delivery Model for Metastatic Breast Cancer

(EPOST MBC Trial)

Overseen By CT Nurse Navigator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: BRCA testing after 2013, Psychiatric illness, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of delivering genetic counseling for individuals with metastatic breast cancer, a type of cancer that has spread to other parts of the body. The trial aims to determine if watching a video on genetic testing, followed by a session with a provider to answer questions, is effective. Individuals with HER2-negative metastatic breast cancer who have not undergone certain genetic tests since 2013 may be suitable candidates. Participants will complete surveys before and after to help evaluate this counseling method. As an unphased trial, this study provides an opportunity to contribute to innovative research that could enhance genetic counseling methods for future patients.

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 delivery model is safe for metastatic breast cancer patients?

In this study, researchers are exploring a new method of providing genetic counseling for people with metastatic breast cancer. This method involves watching a standardized video, followed by a session where a healthcare provider answers questions. Studies on similar approaches, such as watching educational videos, have generally shown they are safe and well-tolerated. No reports of harm or negative reactions have been associated with this type of model, suggesting it is likely low-risk for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Point of Service Delivery Model for metastatic breast cancer because it offers a more personalized and immediate approach to genetic counseling. Unlike traditional methods that might require separate appointments or referrals, this model integrates education directly into the patient's existing care routine. Patients watch a standardized video on genetic testing principles and can immediately ask their provider any questions, streamlining the process and potentially improving understanding and satisfaction. This approach aims to make genetic counseling more accessible and efficient, which could lead to better-informed patients making decisions about their treatment.

What evidence suggests that this point of service delivery model is effective for metastatic breast cancer?

Research has shown that new methods of providing genetic counseling benefit patients with advanced breast cancer. These methods aim to make support more accessible and immediate. In this trial, participants will experience the "Point of Service Delivery Model," where genetic counseling occurs right at the point of care. This approach allows patients to receive information and support when needed, helping them understand their options better and make informed decisions. This method could enhance the overall experience and outcomes for patients seeking genetic counseling. ^{1 2 3 4 6}

Who Is on the Research Team?

Lauren Nye, MD

Principal Investigator

University of Kansas

Are You a Good Fit for This Trial?

This trial is for individuals or their legal representatives who understand the study and consent to participate, speak English, have HER2-negative metastatic breast cancer, and are enrolled in the parent registry study. It excludes those with psychiatric conditions affecting compliance or who've had certain genetic tests after 2013.

Inclusion Criteria

Participants must be enrolled in the parent registry study.

I or my legal representative can understand the study and agree to sign the consent.

My breast cancer is metastatic and HER2 negative.

Exclusion Criteria

I have had genetic testing for BRCA1 and BRCA2 mutations after 2013.

Psychiatric illness/social situations that would limit compliance with study requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants watch a standardized video on genetic testing principles and receive pre- and post-surveys for evaluation

1-2 weeks

1 visit (virtual)

Follow-up

Participants are monitored for outcomes such as genetic testing uptake, satisfaction, decisional conflict, and anxiety

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Point of Service Delivery Model

Trial Overview The trial is evaluating a new point of service delivery model for cancer genetics counseling in patients with metastatic breast cancer. The focus is on its effectiveness when patients receive referrals for hereditary cancer genetic counseling and testing.

How Is the Trial Designed?

Group I: Point of service delivery model Experimental Treatment 1 Intervention

After the informed consent is signed, the participant will watch a standardized video on the principles of genetic testing. At the end of the video, the provider will return to answer any remaining questions. The participant will receive pre- and post- surveys for evaluation of the delivery model.

Point of Service Delivery Model is already approved in European Union, United States for the following indications:

Approved in European Union as Lynparza for:

• Breast cancer
• Ovarian cancer
• Fallopian tube cancer
• Peritoneal cancer
• Pancreatic cancer
• Prostate cancer
• Endometrial cancer

Approved in United States as Lynparza for:

• Ovarian, fallopian tube, and primary peritoneal cancer
• Breast cancer
• Prostate cancer
• Pancreatic cancer

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Published Research Related to This Trial

The C-MOnGene study implemented a collaborative oncogenetic model that successfully doubled the annual number of patients receiving genetic counseling for hereditary breast and ovarian cancer (HBOC) within three years.

The model not only reduced the waiting time for test results but also enhanced patient understanding of breast cancer risk through group counseling, leading to high satisfaction rates among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Collaborative Model to Implement Flexible, Accessible and Efficient Oncogenetic Services for Hereditary Breast and Ovarian Cancer: The C-MOnGene Study. Lapointe, J., Dorval, M., Chiquette, J., et al.[2021]

In a study of 340 patients with breast or ovarian cancer, only 45% of those who met the criteria for genetic counseling were actually referred, highlighting a significant gap in adherence to referral guidelines.

A pilot intervention that notified oncologists about eligible patients for genetic counseling led to a notable increase in referrals, suggesting that such alerts could improve compliance with referral guidelines, especially for ovarian cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the diagnosis of breast or ovarian cancer trigger referral to genetic counseling? Powell, CB., Littell, R., Hoodfar, E., et al.[2018]

A new model of genetic counseling (GC) that includes a 20-minute presentation before a telephone call significantly reduced the time needed for pre-test GC, averaging 19 minutes compared to 46 minutes for traditional in-person counseling.

This modified GC model was found to be non-inferior to traditional methods in terms of psychosocial outcomes like cancer-specific distress and satisfaction, making it an efficient alternative to meet the increasing demand for genetic testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified panel-based genetic counseling for ovarian cancer susceptibility: A randomized non-inferiority study. McCuaig, JM., Tone, AA., Maganti, M., et al.[2019]

There is a growing demand for genetic counseling services in cancer care, highlighting the need for effective service delivery models.

Current models for delivering genetic counseling lack sufficient evidence on their effectiveness for different individuals or healthcare systems, indicating a need for implementation science to evaluate and integrate these models into cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternate delivery models for genetic counseling: clinical and implementation considerations. Rahm, AK.[2020]

In a study of 554 high-risk women comparing telephone genetic counseling (TC) to in-person counseling (UC), TC was found to be significantly more convenient, with participants reporting a 4.78 times higher likelihood of convenience compared to UC.

While overall satisfaction with counseling was similar between TC and UC, TC participants perceived lower levels of support and emotional recognition from counselors, indicating a need for improvement in these areas to enhance the effectiveness of TC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Perceptions of Telephone vs. In-Person BRCA1/BRCA2 Genetic Counseling. Peshkin, BN., Kelly, S., Nusbaum, RH., et al.[2018]

A survey of 192 genetic counselors revealed that the most commonly used service delivery models for cancer genetic counseling are face-to-face pre- and post-test consultations, with alternative models increasing patient access without significantly affecting wait times or travel distances.

While alternative models allow counselors to see more new patients, there are concerns among counselors that these models might compromise the quality of care provided.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Models of service delivery for cancer genetic risk assessment and counseling. Trepanier, AM., Allain, DC.[2022]

The demand for cancer genetic counseling is increasing, necessitating the exploration of alternative service delivery models like telephone counseling, telegenetics, and group counseling to improve access to care.

While preliminary research suggests these alternative models may be acceptable to patients and improve access, further studies are needed to evaluate their long-term effectiveness and outcomes compared to traditional in-person counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternate Service Delivery Models in Cancer Genetic Counseling: A Mini-Review. Buchanan, AH., Rahm, AK., Williams, JL.[2022]

Embedding genetic counseling services directly within gynecologic oncology clinics significantly increased the referral rate for cancer genetics services from 21% to 44% among newly diagnosed ovarian cancer patients, based on a study of 737 patients.

The new model also improved patient scheduling and consultation completion times, with 82% of referred patients scheduled for consultations post-embedding, and 25% being seen on the same day as their referral, highlighting the effectiveness of on-site services in enhancing patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic consultation embedded in a gynecologic oncology clinic improves compliance with guideline-based care. Senter, L., O'Malley, DM., Backes, FJ., et al.[2017]

A centralized telephone genetic counseling service in Australia has improved access to BRCA1/2 testing for women with high-grade serous ovarian cancer, allowing oncologists to refer patients more efficiently and reducing the need for travel, especially for those in rural areas.

Oncologists found the service to be timely and convenient, although they emphasized the need for in-person counseling for patients who received positive BRCA1/2 results, highlighting areas for improvement in communication between the service and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncologists' perspectives of telephone genetic counseling to facilitate germline BRCA1/2 testing for their patients with high-grade serous ovarian cancer. Hemming, P., Kaur, R., Meiser, B., et al.[2021]

Citations

1. lynparza.com lynparza.com/breast-cancer/results/metastatic-breast-cancer.html

Metastatic Breast Cancer - Clinical Study Results of ... LYNPARZA lowered the risk of cancer growing or spreading, or death by 42% compared with certain chemotherapies.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10948524/

Clinical effectiveness and safety of olaparib in BRCA-mutated ... The interim analysis of the phase IIIb LUCY trial demonstrated the clinical effectiveness of olaparib in patients with germline BRCA-mutated ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1706450

Olaparib for Metastatic Breast Cancer in Patients with a ... A complete response was seen in 9.0% of the patients who had measurable disease in the olaparib group and in 1.5% in the standard-therapy group.

4. astrazeneca.com astrazeneca.com/media-centre/press-releases/2024/lynparza-demonstrated-clinically-meaningful-prolonged-survival-benefit-in-early-breast-cancer-in-olympia-phase-iii-trial.html

Lynparza demonstrated clinically meaningful prolonged ... Lynparza reduced the risk of invasive breast cancer recurrence, second cancers or death by 35% (HR 0.65; 95% CI; 0.53-0.78) and reduced the risk ...

5. appliedclinicaltrialsonline.com appliedclinicaltrialsonline.com/view/lynparza-germline-brca-mutated-her2-negative-breast-cancer

Long-Term Data Show Lynparza Significantly Improves ... Data from the OlympiA Phase III trial show Lynparza (olaparib) significantly improved the risk of death, invasive disease-free survival, and distant disease- ...

6. astrazeneca-us.com astrazeneca-us.com/media/press-releases/2017/lynparza-olaparib-significantly-reduces-the-risk-of-disease-worsening-or-death-in-patients-with-brca-mutated-metastatic-breast-cancer-06042017.html

LYNPARZA™ (olaparib) significantly reduces the risk of ... The trial showed that patients treated with LYNPARZA had a 42% reduction in risk of their disease worsening or death.