Trial Summary
What is the purpose of this trial?This is a community-based study requiring participant-self-enrollment, that can help to increase the rates of genetic testing among the family members of people who have been diagnosed with a hereditary cancer syndrome. The two main factors in this study are the IGNITE-TX intervention (website and navigator) and the free genetic counseling and testing.
The IGNITE-TX Intervention is an innovative multi-modal intervention, with two components: a) interactive web "IGNITE-TX Hub" and b) genetic family navigators.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on genetic testing and counseling, so it's unlikely that your current medications would be affected.
What data supports the effectiveness of the treatment Free genetic testing and counseling group, IGNITE-TX and free genetic testing and counseling group, IGNITE-TX Group?
Research shows that genetic counseling and testing can help identify individuals at risk for hereditary cancers, like breast and ovarian cancer, allowing for better prevention and treatment strategies. Additionally, studies suggest that telephone genetic counseling is as effective as in-person counseling for reducing cancer-related stress and improving genetic knowledge.
12345Is genetic testing and counseling for hereditary cancer safe for humans?
The research does not provide specific safety data for genetic testing and counseling, but these services are generally considered safe as they involve analyzing genetic information and providing guidance based on the results.
678910How does the treatment 'Free genetic testing and counseling group, IGNITE-TX' differ from other treatments for hereditary cancer?
This treatment is unique because it offers free genetic testing and counseling, which helps identify individuals at risk for hereditary cancer before they develop the disease, allowing for preventive measures and personalized risk management strategies. Unlike standard treatments that focus on managing cancer after diagnosis, this approach emphasizes early detection and prevention.
611121314Eligibility Criteria
This trial is for adults in the U.S. who speak English or Spanish, have internet access, and a known genetic mutation linked to certain cancers (like BRCA1/2 or Lynch Syndrome) in their family. They should have at least one relative also at risk but can't join if they've already been tested negative for these mutations or don't have any relatives who could be affected.Inclusion Criteria
I have a close family member who also meets the trial's requirements.
I am 18 years old or older.
I can show that a close family member has a harmful gene variant linked to cancer.
+4 more
Exclusion Criteria
My family members do not qualify for this clinical trial.
You have already been listed as an affected relative for another person in the study.
I have been tested for the same genetic variant found in my family member.
+3 more
Participant Groups
The study tests an intervention called IGNITE-TX which includes a web platform and personal navigators to increase genetic testing rates among families with hereditary cancer syndromes. It compares the effectiveness of this approach with free genetic counseling and testing services.
4Treatment groups
Experimental Treatment
Active Control
Group I: Group 4 (IGNITE-TX and free genetic testing and counseling group)Experimental Treatment3 Interventions
Relatives randomized to this arm will receive a family letter after enrollment and baseline survey with their personal access codes (not to be shared) to the IGNITE-TX "Hub" (access online educational material through a platform) and information to contact the tele genetics company. This arm will receive both the IGNITE-TX Intervention and access to free genetic testing and counseling services, as well as access to assistance from family genetic navigator
Group II: Group 3 (IGNITE-TX Group)Experimental Treatment3 Interventions
Relatives of probands randomized to the IGNITE-TX intervention will receive a family letter after enrollment and baseline survey with their personal access codes (not to be shared) to the IGNITE-TX "Hub" (access online educational material through a platform). Relatives will have also access services of a family genetic navigator. Study investigators and navigators will not directly provide genetic counseling and/or testing in this arm
Group III: Group 2 (Free genetic testing and counseling group)Experimental Treatment3 Interventions
Enrolled relatives will receive a letter and baseline survey with information to contact the tele-genetics company to arrange free genetic counseling and testing. This letter will be given to the relatives directly by the study
Group IV: Group 1 (Standard of Care Group)Active Control1 Intervention
Participants (probands, those with a hereditary cancer syndrome) are sent a family letter to share with relatives. The letter contains information about hereditary cancer syndromes and encourages relatives to participate in the study and to get genetic testing.
Relatives of probands randomized to the usual care arm will have access to the family letter if probands decide to share it with them, and will receive study surveys. The letter contains information about hereditary cancer syndromes and encourages relatives to participate in the study and to get genetic testing
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
MD Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
References
Breast cancer genetics and managed care. The Kaiser Permanente experience. [2019]In 1996, with evolution of the science of cancer genetics and the advent of commercially available BRCA1 and later BRCA2 testing, Kaiser Permanente began to apply these advances in clinical practice. Recommendations for referral to genetic counseling were developed in 1997 as the Clinical Practice Guidelines for Referral for Genetic Counseling for Inherited Susceptibility for Breast and Ovarian Cancer. Implementation of these guidelines with associated protocols in Kaiser Permanente's Northern California Region has occupied the ensuing years and includes dissemination of the high-risk guidelines for breast and ovarian cancer, dissemination of patient and physician educational materials on the breast cancer guidelines, monthly classes and taped healthphone messages for patients, interactive videoconferencing for physicians, a training seminar for medical geneticists who will counsel patients at risk, publication of articles on breast cancer and genetic risk in health plan member- and physician-directed magazines, identification and training of clinical specialists and supporting clinicians to care for patients before and after counseling, individual counseling and testing of patients and families, and development of a data registry. Implementing the guidelines helped us communicate the uncertainty surrounding breast cancer testing, and we were obliged to learn more about ethical, legal, societal, and insurance controversies surrounding genetic testing. Given the lack of effective prevention for breast or ovarian cancer and the difficulty of treatment, the appropriate use of genetics in patient care is essential. In the near future, we will see the need for cancer genetics to become an integral part of practice throughout the spectrum of health care. We at Kaiser Permanente feel that the breast cancer guideline project is the first step in this process.
Facilitated referral pathway for genetic testing at the time of ovarian cancer diagnosis: uptake of genetic counseling and testing and impact on patient-reported stress, anxiety and depression. [2020]Timely genetic testing at ovarian cancer diagnosis is essential as results impact front line treatment decisions. Our objective was to determine rates of genetic counseling and testing with an expedited genetics referral pathway wherein women with newly-diagnosed ovarian cancer are contacted by a genetics navigator to facilitate genetic counseling.
[Recommended Extension of Indication Criteria for Genetic Testing of BRCA1 and BRCA2 Mutations in Hereditary Breast and Ovarian Cancer Syndrome]. [2019]Genetic testing for hereditary breast and ovarian cancer syndrome is indicated by a genetic counselor on the basis of personal and family history evaluation, with regards to consensual criteria, reflecting the current knowledge. The latest recommendation accepted by Czech Oncology Society and Society of Medical Genetics was published in the supplement 22 to the Journal of Clinical Oncology in 2009. Since the availability of PARP inhibitors for treatment of ovarian cancer in BRCA1/ 2 mutation carriers, an update of these guidelines is urgently needed. Another reason is a higher incidence of other malignancies in high-risk families, such as prostate or pancreatic cancer. The goal is to refine the detection of mutations in selected families, to improve preventive care and collect data necessary for targeted cancer treatment.
A systematic review and meta-analysis of telephone vs in-person genetic counseling in BRCA1/BRCA2 genetic testing. [2021]Pathogenic variants in the BRCA1 and BRCA2 genes increase the risk of breast and ovarian cancer. Individuals with identified pathogenic variants in the BRCA1 or BRCA2 gene can benefit from cancer risk-reducing strategies. In the recent years, there has been an increase in the demand of genetic services. In light of the ongoing COVID19 pandemic, alternatives to face-to-face consultations have had to be considered and adopted, including telemedicine. Informed consent is necessary for genetic testing. Studies have suggested that increased levels of cancer-specific distress may impair the patient's ability to retain information, therefore, providing informed consent. This systematic review and meta-analysis aimed to answer if telephone genetic counseling for BRCA1 and BRCA2 genetic testing is non-inferior to in-person genetic counseling for the outcomes of cancer-specific distress and genetic knowledge. Databases of Medline, Embase, PsycINFO, CINAHL, SciELO, Web of Science, CENTRAL, ProQuest Dissertation & Theses Database, Clinicaltrials.gov, EU clinical trials register were accessed to identify any published or unpublished relevant literature. Random-effects models were used for the meta-analysis. Four studies were included in the qualitative synthesis of the results. Three studies were included in the quantitative synthesis of the results. Telephone genetic counseling was non-inferior compared to in-person genetic counseling for the outcomes of cancer-specific distress and genetic knowledge. Sensitivity analysis corroborated the main results. Telephone genetic counseling for BRCA1/BRCA2 genetic testing may be an alternative model of delivering genetic services in front of the increased demand/or when required by social context. However, the paucity of the evidence prevents from drawing strong conclusions regarding the generalizability of these results. Further research is needed to strengthen the conclusions.
Hereditary diffuse gastric cancer and lynch syndromes in a BRCA1/2 negative breast cancer patient. [2018]Genetic counseling and testing is recommended for women with a personal and/or family history of breast and other cancers (ovarian, pancreatic, male breast and others). Mutations in the BRCA1 and BRCA2 genes (BRCA1/2) are the most common causes of hereditary breast and ovarian cancer. Additional genetic counseling and testing with a multi-gene panel may be considered in breast cancer patients who tested negative for mutations in these two genes. In about 11% of BRCA1/2-negative patients, further genetic testing reveals pathogenic mutations in other high or moderate cancer risk genes. In 0.2% of cases, an individual may carry pathogenic mutations in more than one high penetrance gene (a double heterozygote). Finding one or more pathogenic mutations is important for cancer prevention in patients and/or their families.
Testing and counseling adults for heritable cancer risk. [2018]A summary of recommendations from a breakout session of a Workshop on Hereditary Breast, Ovarian and Colon Cancer held in Washington, DC, in April 1994 is presented here. The focus of the session was the provision of testing and counseling services for adults at increased risk for developing cancer. Elements of service provision involving three time-points for counseling (pretest education, risk notification, and follow-up) and suggested areas of research are outlined for discussion.
Communication of BRCA results and family testing in 1,103 high-risk women. [2022]Genetic testing for hereditary cancer risk has implications for individuals and families. This study of women at risk of hereditary breast and ovarian cancer examines communication of BRCA results and subsequent genetic testing in the family.
Women's experiences of undergoing BRCA1 and BRCA2 testing: organisation of the German Hereditary Breast and Ovarian Cancer Consortium Survey and Preliminary Data from Münster. [2017]In order to promote safe and effective testing for BRCA1 and BRCA2 mutations in clinical practice, a network of expert centres in hereditary breast and ovarian cancer ('Verbundprojekt familiärer Brust- und Eierstockkrebs'; German Consortium on Hereditary Breast and Ovarian Cancer) has been established by the Deutsche Krebshilfe (German Cancer Aid). To improve practice, evaluations based upon the views of patients who have undergone testing concerning the impact of the genetic diagnosis and the quality of the services they receive and require are undertaken.
Genetic counselor approaches to BRCA1/2 direct-to-consumer genetic testing results. [2021]The National Comprehensive Cancer Network recommends clinical-grade genetic testing to confirm commercial results from direct-to-consumer genetic testing (DTC-GT) companies and third-party interpretation (TPI) services; however, the type of confirmatory testing that genetic counselors (GCs) recommend remains uncharacterized. Therefore, we aimed to describe GCs testing strategies for patients who have already obtained DTC-GT results (23andMe) or TPI data (Promethease) that reported a BRCA1/2 pathogenic variant. We invited GCs specializing in clinical cancer genetics to complete an online survey distributed to members of the National Society of Genetic Counselors. The survey, completed by 80 respondents, contained case scenarios featuring probands with variable personal and family histories of cancer. Our results show that the majority of participating GCs have counseled patients for their health-related commercial test results; 94% have encountered patient DTC-GT reports (3 per year), and 69% have encountered patient TPI data (2 per year). Most participating GCs would recommend confirmatory clinical-grade testing for probands with a positive 23andMe BRCA1/2 result (77/80, 96%). However, there was strong variability between the type of recommended testing. Approximately 20% recommended single-site analysis, 11%-14% recommended the three Ashkenazi Jewish BRCA1/2 founder mutations, 4% recommended BRCA1/2 testing, and 61%-64% recommended multi-gene panel testing. The most commonly recommended panels were split between a breast and gynecological cancer-focused panel and a broad pan-cancer panel. The majority of participants (98%-100%) would also recommend confirmatory testing for patients with positive TPI data for BRCA1/2. Similarly, results were mixed between those who recommended targeted, single-site analysis (10%-15%) compared to a multi-gene panel (72%-83%). These data show that while most GCs were uniform in their practice of recommending confirmatory testing, they are mixed in their approach to the specific type of testing they would select. These results may help inform counseling approaches and consensus for this expanding group of patients.
Next-generation universal hereditary cancer screening: implementation of an automated hereditary cancer screening program for patients with advanced cancer undergoing tumor sequencing in a large HMO. [2023]Variants in hereditary cancer risk genes are frequently identified following tumor-based DNA sequencing and represent an opportunity to diagnose hereditary cancer. We implemented an automated hereditary cancer screening program in a large HMO for all patients who underwent tumor-based DNA sequencing to identify patients with hereditary cancer and determine if this approach augmented existing genetic counseling approaches driven by personal/family history criteria. Regular automated searches of a centralized tumor DNA variant database were performed for ATM, BRCA1, BRCA2, MLH1, MSH2, MSH6, PALB2, and/or PMS2 variants, and germline hereditary cancer gene panel testing was offered to patients with tumor variants who had never undergone germline testing. Patients completing germline testing due to their tumor DNA test results were considered part of the tumor DNA safety net. Patients previously completing germline testing via traditional genetic counseling and tumor DNA safety net were compared for demographics, tumor type, presence of germline pathogenic/likely pathogenic (P/LP) variant, and whether NCCN criteria were met for hereditary cancer genetic testing. Germline P/LP variants were common in both groups. Patients who received germline testing through traditional genetic counseling were more likely to have cardinal hereditary tumors than the tumor DNA safety net group. Patients identified with hereditary cancer through traditional genetic counseling were more likely to meet NCCN personal/family history criteria for germline testing than the tumor DNA safety net group (99% versus 34%). A universal tumor DNA safety net screen is an important diagnostic strategy which augments traditional genetic counseling approaches based on personal/family history.
SEOM recommendations on the structure and operation of hereditary cancer genetic counseling units (HCGCUs). [2021]Approximately 5 % of all cancer cases are hereditary. Cancer genetic counseling assesses individual and family risks of cancer, conducts genetic studies, interprets results, and advises patients regarding strategies for prevention and risk reduction. Currently, many networks of hereditary cancer genetic counseling units (HCGCUs) are integrated in the medical oncology services of most Spanish hospitals, which are comprised of multidisciplinary teams and offer high-quality care for the treatment of hereditary cancer.
Genetic counseling and clinical cancer genetics services. [2019]Cancer genetic services, typically provided by clinicians with expertise in both oncology and genetics, include cancer risk assessment and education, facilitation of genetic testing, pre-and post-test counseling, provision of personally tailored cancer risk management options and recommendations, and psychosocial counseling and support services. All oncology providers should obtain basic information on the family cancer history of their patients to determine the likelihood of hereditary cancer risk as well as possible indications for providing brief or comprehensive cancer genetic counseling. Those who choose to provide these services themselves must be familiar with the complex issues of genetic counseling and testing, and be aware of the time and expertise required to adequately deliver these services. Genetic nurses and genetic counselors with master's degrees function as valuable members of a comprehensive cancer genetic service; they are trained to independently collect and confirm medical and family history information, perform risk assessments, offer patient education regarding cancer and genetics, and provide supportive counseling services for patients and families. It is hoped that specific risk interventions will significantly reduce morbidity and mortality from familial forms of cancer. This review outlines the process of cancer genetic counseling and defines the roles of the cancer genetic counselor and the function of the cancer genetics specialty clinic. The possible medical and legal implications for failing to obtain adequate family history information are reviewed, and the issues of genetic discrimination are discussed.
Interdisciplinary risk counseling for hereditary breast and ovarian cancer: real-world data from a specialized center. [2023]Hereditary breast and ovarian cancer has long been established to affect a considerable number of patients and their families. By identifying those at risk ideally before they have been diagnosed with breast and/or ovarian cancer, access to preventive measures, intensified screening and special therapeutic options can be obtained, and thus, prognosis can be altered beneficially. Therefore, a standardized screening and counseling process has been established in Germany under the aegis of the German Consortium for Hereditary Breast and Ovarian Cancer (GC-HBOC). As one of these specialized clinics, the HBOC-Center at Charité offers genetic counseling as well as genetic analysis based on the GC-HBOC standards. This analysis aims first at depicting this process from screening through counseling to genetic analysis as well as the patient collective and second at correlating the results of genetic analysis performed. Thus, real-world data from an HBOC-Center with a substantial patient collective and a high frequency of pathogenic variants in various genes shall be presented.
Perceptions and care Recommendations from Previvors: Qualitative analysis of female BRCA1/2 mutation Carriers' experience with genetic testing and counseling. [2022]Label="Introduction" NlmCategory="UNASSIGNED">It is estimated that 12.5% of women will be diagnosed with breast cancer and 1.10% with ovarian cancer during their lifetime. Although less common, women with these mutations have a 11-72% increased risk of breast/ovarian cancers and are hereditary. Genetic testing/counseling presents the opportunity to identify carriers of BRCA1/2 genetic mutations before a cancer diagnosis.