Genetic Counseling for Cancer Risk
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: M.D. Anderson Cancer Center
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?To identify Black individuals who are eligible for genetic testing through trusted community organizations, and to connect Black individuals and their families to genetic testing and counseling so that they can know their cancer risk and how to decrease it.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Genetic Testing and Counseling for cancer risk?
Research shows that genetic counseling and testing can identify individuals at higher risk for hereditary cancer, allowing for targeted prevention and early detection strategies, which can reduce illness and death from cancer. This approach is especially effective when combined with education and personalized risk management, ensuring patients understand the benefits and implications of genetic testing.
12345Is genetic counseling for cancer risk safe?
Genetic counseling and testing for cancer risk are generally considered safe, but there have been reports of errors when performed by clinicians without specialized training, which can lead to negative outcomes for patients and their families.
12678How is the treatment Genetic Testing and Counseling different from other treatments for cancer risk?
Genetic Testing and Counseling is unique because it focuses on identifying individuals at risk for hereditary cancer before diagnosis, allowing for targeted prevention and management strategies. Unlike other treatments that address cancer after it develops, this approach uses genetic information to guide decisions and reduce cancer risk proactively.
12389Eligibility Criteria
This trial is for Black or African-American individuals over the age of 18 living in Houston, Texas. Participants must be willing to sign a 'Permission to Contact' form consenting to join the study.Participant Groups
The trial aims to use a simple genetic risk screening tool and telegenetics (remote genetic counseling) to connect participants with their hereditary cancer risks for conditions like colorectal and breast cancer.
2Treatment groups
Experimental Treatment
Group I: Screening FormExperimental Treatment1 Intervention
Participants will complete a screening form to assess your risk of hereditary breast and colorectal cancers. You will be asked to provide your:
* Name and contact information (including your address, phone number, and email)
* Demographic information (including your age, race, and ethnicity)
* Health insurance status
* Annual household income
* Personal and family history of cancer, including diagnosis and age at diagnosis
Group II: Genetic Testing and CounselingExperimental Treatment1 Intervention
Participants will be given a saliva collection kit to collect a saliva sample for hereditary cancer and genetic testing.
Genetic Testing and Counseling is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Genetic Counseling and Testing for:
- Hereditary breast cancer
- Hereditary ovarian cancer
- Hereditary colorectal cancer
- Other hereditary cancers
🇪🇺 Approved in European Union as Genetic Counseling and Testing for:
- Hereditary breast cancer
- Hereditary ovarian cancer
- Hereditary colorectal cancer
- Other hereditary cancers
🇨🇦 Approved in Canada as Genetic Counseling and Testing for:
- Hereditary breast cancer
- Hereditary ovarian cancer
- Hereditary colorectal cancer
- Other hereditary cancers
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
Identifying hereditary cancer: genetic counseling and cancer risk assessment. [2014]The goal of cancer genetic counseling, risk assessment, and testing is to identify individuals and families at risk for hereditary cancer, such that targeted management strategies can be used to reduce associated morbidity and mortality. Involvement of a qualified cancer genetic service provider helps to ensure that at-risk individuals identified and offered appropriate education, risk assessment, genetic testing, and follow-up risk management strategies. There are multiple screening and hereditary risk models available to help the clinician identify who needs to be referred to cancer genetic counseling and to facilitate the cancer risk assessment process. Genetic testing should only be pursued with fully informed consent in the context of pretest counseling to ensure that the individual understands the benefits, risks, and limitations of genetic testing, possible results, and their implications. Incorporating psychosocial assessment throughout the counseling session may assist the individual in their understanding of genetic testing in the context of their support resources and coping mechanisms and may help with decision making. There is a growing public awareness of and interest in cancer genetic testing, as well as increasing complexity of available testing options and results. It is therefore essential that cancer genetic professionals, primary care providers, and oncology practitioners work together to ensure that genetic testing for hereditary cancer syndromes is used in the most appropriate and effective way.
Genetic risk assessment in breast and gynecologic malignancies- what's to know in 2024? [2023]Hereditary cancer risk assessment and counseling have become integral in oncology care, especially in breast and gynecologic malignancies where genetic test results impact management. However, a large number of patients who could benefit from genetic testing are not getting tested. As such, genetic risk assessment and counseling methods have had to evolve to meet the needs of this expanding patient population.
If we build it ... will they come?--establishing a cancer genetics services clinic for an underserved predominantly Latina cohort. [2022]Cancer genetic counseling and testing is a standard of care option for appropriate families and can identify individuals at increased risk prior to diagnosis, when prevention or detection strategies are most effective. Despite documented efficacy of cancer risk reduction in high-risk individuals, underserved and minority individuals have a disproportionate cancer burden and limited access to genetic counseling.
Genetic testing. [2019]New research developments in the molecular genetics of cancer have led to the feasibility of cancer genetic testing. At present, genetic test results can better inform individuals at risk about appropriately tailored strategies for cancer screening and prevention. In the future, more persons will be eligible for genetic evaluation; in particular, if it is shown that patients with cancer who are carriers of germline mutations respond differently to treatments, genetic testing may be warranted. Consideration needs to be given to the appropriate delivery of genetic risk assessment and testing. There is a great potential for misinterpretation of gene test results and for adverse psychosocial consequences for patients. Genetic counseling is an important component in cancer risk assessment and management, particularly in helping persons at risk understand the implications of gene test results in the context of their experience with cancer and surveillance.
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.
Common hereditary cancer syndromes. [2019]To review cancer risk assessment and counseling, hereditary cancer syndrome risk factors, indicators for cancer predisposition testing, and interpretation of genetic test results.
Adverse events in cancer genetic testing: medical, ethical, legal, and financial implications. [2013]Cancer genetic counseling and testing are now integral services in progressive cancer care. There has been much debate over whether these services should be delivered by providers with specialized training in genetics or by all clinicians. Adverse outcomes resulting from cancer genetic counseling and testing performed by clinicians without specialization in genetics have been reported, but formal documentation is sparse. In this review, we present a series of national cases illustrating major patterns of errors in cancer genetic counseling and testing and the resulting impact on medical liability, health care costs, and the patients and their families.
Genetic risk assessment, counseling and testing. [2009]Hereditary cancer risk assessment, counseling, and testing are becoming ever more complex as the understanding of the genetic components of disease grows. The demand for highly trained professionals with expertise in this field, such as genetic counselors, is also growing. Surgical oncologists are likely to encounter patients with hereditable cancer syndromes in their practice and should be able to identify patients appropriate for genetic assessment and counseling.
Will cancer risk assessment and counseling services survive genetic testing? [2019]With the availability of genetic testing to detect increased hereditary susceptibility to breast and other cancers, Cancer Risk Assessment and Counseling services have come to be viewed by many primarily as a means of obtaining genetic testing and hereditary risk information. The public and healthcare professionals need to be aware that even when genetic testing is not used or is uninformative, families with and without a strong family history of cancer will benefit from Cancer Risk Assessment and Counseling if the process includes assessment of cancer risk, information about cancer etiology, help in dealing with the psychosocial consequences of the cancer experience, and development of emotional and medical coping strategies. Risk assessment services can best serve concerned individuals and their families when sufficient time is allotted for these primary aims, and when genetic testing is seen as one of the useful tools, not the primary goal of such services.