Genetic Counseling Delivery Model for Metastatic Breast Cancer
(EPOST MBC Trial)
Recruiting in Palo Alto (17 mi)
Overseen byLauren Nye, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Kansas Medical Center
Disqualifiers: BRCA testing after 2013, Psychiatric illness, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This study will assess the efficacy of an innovative point of service cancer genetics counseling delivery model for metastatic breast cancer (MBC) patients whom have received a referral for hereditary cancer genetic counseling and testing.
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 Point of Service Delivery Model, Lynparza, for metastatic breast cancer?
The research highlights that alternative service delivery models, like group counseling, can improve patient understanding and satisfaction in genetic counseling for breast cancer, suggesting that flexible and patient-centered approaches may enhance the effectiveness of treatments like Lynparza when integrated into oncology care.
12345Is the genetic counseling delivery model for metastatic breast cancer safe?
The research on genetic counseling delivery models, such as telephone and group counseling, suggests they are generally safe and well-received by patients, improving access to care without significant safety concerns.
23678How does the drug Lynparza differ from other treatments for metastatic breast cancer?
Lynparza is unique because it is a targeted therapy that works by inhibiting a specific enzyme called PARP (poly ADP ribose polymerase), which helps repair DNA damage in cancer cells. This mechanism is different from traditional chemotherapy, which attacks rapidly dividing cells in general, making Lynparza a more precise treatment option for certain patients with metastatic breast cancer.
23459Eligibility Criteria
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.
+1 more
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.
Trial Timeline
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Point of service delivery modelExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of Kansas Cancer Center, Westwood CampusKansas City, KS
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Who Is Running the Clinical Trial?
University of Kansas Medical CenterLead Sponsor
References
Genetic consultation embedded in a gynecologic oncology clinic improves compliance with guideline-based care. [2017]Analyze the impact of embedding genetic counseling services in gynecologic oncology on clinician referral and patient uptake of cancer genetics services.
Alternate Service Delivery Models in Cancer Genetic Counseling: A Mini-Review. [2022]Demand for cancer genetic counseling has grown rapidly in recent years as germline genomic information has become increasingly incorporated into cancer care, and the field has entered the public consciousness through high-profile celebrity publications. Increased demand and existing variability in the availability of trained cancer genetics clinicians place a priority on developing and evaluating alternate service delivery models for genetic counseling. This mini-review summarizes the state of science regarding service delivery models, such as telephone counseling, telegenetics, and group counseling. Research on comparative effectiveness of these models in traditional individual, in-person genetic counseling has been promising for improving access to care in a manner acceptable to patients. Yet, it has not fully evaluated the short- and long-term patient- and system-level outcomes that will help answer the question of whether these models achieve the same beneficial psychosocial and behavioral outcomes as traditional cancer genetic counseling. We propose a research agenda focused on comparative effectiveness of available service delivery models and how to match models to patients and practice settings. Only through this rigorous research can clinicians and systems find the optimal balance of clinical quality, ready and secure access to care, and financial sustainability. Such research will be integral to achieving the promise of genomic medicine in oncology.
A Collaborative Model to Implement Flexible, Accessible and Efficient Oncogenetic Services for Hereditary Breast and Ovarian Cancer: The C-MOnGene Study. [2021]Medical genetic services are facing an unprecedented demand for counseling and testing for hereditary breast and ovarian cancer (HBOC) in a context of limited resources. To help resolve this issue, a collaborative oncogenetic model was recently developed and implemented at the CHU de Québec-Université Laval; Quebec; Canada. Here, we present the protocol of the C-MOnGene (Collaborative Model in OncoGenetics) study, funded to examine the context in which the model was implemented and document the lessons that can be learned to optimize the delivery of oncogenetic services. Within three years of implementation, the model allowed researchers to double the annual number of patients seen in genetic counseling. The average number of days between genetic counseling and disclosure of test results significantly decreased. Group counseling sessions improved participants' understanding of breast cancer risk and increased knowledge of breast cancer and genetics and a large majority of them reported to be overwhelmingly satisfied with the process. These quality and performance indicators suggest this oncogenetic model offers a flexible, patient-centered and efficient genetic counseling and testing for HBOC. By identifying the critical facilitating factors and barriers, our study will provide an evidence base for organizations interested in transitioning to an oncogenetic model integrated into oncology care; including teams that are not specialized but are trained in genetics.
Alternate delivery models for genetic counseling: clinical and implementation considerations. [2020]The demand for genetic counseling services and the need for alternate service delivery models to meet this demand in cancer care is continually growing. Models exist, however, there is little evidence on which models work best for which individuals or healthcare systems. Implementation science offers the tools to address this gap and evaluate such models in context for broader impact to integrate these models into cancer care delivery.
Models of service delivery for cancer genetic risk assessment and counseling. [2022]Increasing awareness of and the potentially concomitant increasing demand for cancer genetic services is driving the need to explore more efficient models of service delivery. The aims of this study were to determine which service delivery models are most commonly used by genetic counselors, assess how often they are used, compare the efficiency of each model as well as impact on access to services, and investigate the perceived benefits and barriers of each. Full members of the NSGC Familial Cancer Special Interest Group who subscribe to its listserv were invited to participate in a web-based survey. Eligible respondents were asked which of ten defined service delivery models they use and specific questions related to aspects of model use. One-hundred ninety-two of the approximately 450 members of the listserv responded (42.7%); 177 (92.2%) had provided clinical service in the last year and were eligible to complete all sections of the survey. The four direct care models most commonly used were the (traditional) face-to-face pre- and post-test model (92.2%), the face-to-face pretest without face-to-face post-test model (86.5%), the post-test counseling only for complex results model (36.2%), and the post test counseling for all results model (18.3%). Those using the face-to-face pretest only, post-test all, and post-test complex models reported seeing more new patients than when they used the traditional model and these differences were statistically significantly. There were no significant differences in appointment wait times or distances traveled by patients when comparing use of the traditional model to the other three models. Respondents recognize that a benefit of using alternative service delivery models is increased access to services; however, some are concerned that this may affect quality of care.
Patient Perceptions of Telephone vs. In-Person BRCA1/BRCA2 Genetic Counseling. [2018]Telephone genetic counseling (TC) for hereditary breast/ovarian cancer risk has been associated with positive outcomes in high risk women. However, little is known about how patients perceive TC. As part of a randomized trial of TC versus usual care (UC; in-person genetic counseling), we compared high risk women's perceptions of: (1) overall satisfaction with genetic counseling; (2) convenience; (3) attentiveness during the session; (4) counselor effectiveness in providing support; and (5) counselor ability to recognize emotional responses during the session. Among the 554 participants (TC, N = 272; UC, N = 282), delivery mode was not associated with self-reported satisfaction. However, TC participants found counseling significantly more convenient than UC participants (OR = 4.78, 95 % CI = 3.32, 6.89) while also perceiving lower levels of support (OR = 0.56, 95 % CI = 0.40-0.80) and emotional recognition (OR = 0.53, 95 % CI = 0.37-0.76). In exploratory analyses, we found that non-Hispanic white participants reported higher counselor support in UC than in TC (69.4 % vs. 52.8 %; OR = 3.06, 95 % CI = 1.39-6.74), while minority women perceived less support in UC vs. TC (58.3 % vs. 38.7 %; OR = 0.80, 95 % CI = 0.39-1.65). We discuss potential research and practice implications of these findings which may further improve the effectiveness and utilization of TC.
Does the diagnosis of breast or ovarian cancer trigger referral to genetic counseling? [2018]Kaiser Permanente Northern California is a large integrated health care delivery system in the United States that has guidelines for referring women with newly diagnosed BRCA1-and BRCA2-associated cancers for genetic counseling. This study assesses adherence to genetic counseling referral guidelines within this health system.
Oncologists' perspectives of telephone genetic counseling to facilitate germline BRCA1/2 testing for their patients with high-grade serous ovarian cancer. [2021]Poly ADP ribose polymerase (PARP) inhibitors offer a survival advantage to women with high-grade serous ovarian cancer who have a germline BRCA1/2 pathogenic variant (PV). Yet, rates of genetic testing among this population have remained persistently low. A national, centralized telephone genetic counseling service was established in January 2016 in Australia to improve access to genetic services and facilitate BRCA1/2 testing for this population to inform treatment. Medical oncologists can refer their patients with high-grade serous ovarian cancer to this service for genetic testing. This study aimed to explore oncologists' experiences of using this telephone genetic counseling service for their patients with high-grade serous ovarian cancer. A qualitative approach using semi-structured telephone interviews was undertaken with Australian oncologists who had referred patients to the telephone genetic counseling service. Sixteen oncologists participated and described referring patients to the telephone genetic counseling service due to the timeliness of obtaining a genetic counseling appointment and BRCA1/2 test results. They also reported this service offered convenience for patients living in regional or rural areas who then did not have to travel for an appointment with a clinical genetics service. Many oncologists noted the importance of in-person genetic counseling for patients who received positive BRCA1/2 results. Areas for improvement identified by the oncologists related to communication issues between the service and the patient. Overall, findings suggest that oncologists perceived telephone genetic counseling as an acceptable and useful healthcare service for patients with high-grade serous ovarian cancer. Moreover, they perceived telephone genetic counseling to be efficient, delivering convenient genetic counseling to patients.
Modified panel-based genetic counseling for ovarian cancer susceptibility: A randomized non-inferiority study. [2019]Genetic testing identifies cancer patients who may benefit from targeted treatment and allows for enhanced cancer screening and risk-reduction in their at-risk relatives. Traditional models of genetic counseling (GC) cannot meet the increasing demand and urgency for genetic testing. The objective of this study was to evaluate a new model of service delivery to improve the efficiency of pre-test GC for panel-based genetic testing.