View clinical trials related to Cancer Genetics.
Filter by:Background: - Women who have a BRCA1/2 gene mutation have a very high risk of developing breast or ovarian cancer. They are also at increased risk of other developing other cancers. Male carriers are at increased risk for breast, prostate and other cancers. Testing for this mutation and living with this increased risk can be a source of stress for both people with the mutation and their partners. Researchers want to look at how well people adapt to living with this type of cancer risk over time. Objectives: - To see how women with the BRCA1/2 gene mutation and their partners adapt to the stress of long-term cancer risk. Eligibility: - Women at least 18 years of age who have a BRCA1/2 mutation, and their male or female partners. Design: - This study involves a one-time self-administered questionnaire. Participants will be recruited from local and national hereditary cancer support groups and cancer centers. - There are two versions of the survey. One is for the woman with the BRCA1/2 gene mutation. The other is for her partner. - The survey will ask about risk perception, cancer worry, risk-related stress, and coping and adaptation methods. - Treatment will not be provided as part of this study.
Background An important part of individuals undergoing genetic counseling and/or testing for cancer experience psychosocial problems and worries during or after this process. Approximately 20% of these individuals experience serious problems, such as fear for cancer in themselves or their relatives, family communication problems, unresolved grief, problems in coping with the DNA-test-results, difficulties in choices with regard to DNA-testing, preventive surgeries, and concerns about insurance or work. Research shows that these problems are frequently undetected by the counselors. Within the limited available time of a counseling session, a lot of information should be given to the counselee. This information is mostly biomedical and provider driven. Therefore psychosocial issues can be underexposed. The use of a brief questionnaire, completed by the counselee prior to the counseling session, can serve as a tool for the counselor to screen and address the relevant psychosocial issues in a systematic manner. Therefore, in 2009-2010 the investigators have developed and validated the 'Signal-checklist' to identify relevant psychosocial problems frequently encountered in the cancer-genetics setting, and need for extra psychosocial services. This 'Signal-checklist' can serve as a tool in screening systematically for psychosocial issues, addressing these issues and directing appropriate referrals to extra psychosocial services. The Signal-Trial will be performed to evaluate the use and effectiveness of the checklist. Aim The aim of the trial is to evaluate the implementation of a short, self-developed cancer-genetics checklist; the 'Signal-checklist', as an aid in 1) facilitating communication on psychosocial issues during the genetic counseling session, 2) increasing counselors awareness of psychosocial problems of the counselee, and 3) improving the management of these psychosocial problems during and after the process of genetic counselling. Method This study is a collaboration between the family cancer clinics of the NKI-AVL and the UMCU. Individuals requesting genetic counseling for the high incidence of cancer in their family are invited to participate in the trial. Participants will be asked to complete the 'Signal checklist' prior to their counseling visit. Participants (N=264) will be randomly assigned to one of the two study arms. The intervention group will receive feed-back on the 'Signal-checklist', whereas the control group will not receive feed-back. Three weeks after the DNA-test disclosure session, participants will be asked to complete again the 'Signal-checklist' followed by a telephone call by their counselor. Again, the results of the 'Signal-checklist' will be available to the counselor for participants in the intervention group, but not for the control group. Both the genetic counseling session and telephone call will be audio taped. Furthermore, all participants will be asked to complete three questionnaires on the Internet (or by mail, if preferred); 1) before randomization (3 weeks prior to the counseling session), 2) three weeks after the counseling session, and 3) four months after the potential DNA-test result disclosure. These questionnaires include items on communication during genetic counseling, the need for professional psychosocial support, cancer worries, satisfaction with received care, and experiences with the use of the 'Signal-checklist'. The audio-tapes and completed questionnaires will be used to measure psychosocial problems of the counselees, the awareness of the counselors of these problems, and the management of these problems. Secondary analysis will be conducted to assess the need for extra psychosocial services, satisfaction with genetic counseling, feasibility of implementing the 'Signal-checklist' and decreasing psychosocial problems over time.
Background: - Certain genetic mutations are linked to higher rates of cancer. It is important for people with these mutations to tell their families about it. This is because others in the family may also be at greater risk for developing these cancers. They can also pass these genes to their own children. But not much is known about how African Americans tell their family members about the results of their genetic testing. The information from this study can be used to improve genetic counseling services. These services will then be more effective in early cancer detection and prevention in the African American community. Objectives: - To learn more about how African Americans who have tested positive for BRCA1/2 mutations tell their families about their genetic risk. Eligibility: - African American (or of African descent) women who recently received positive test results for BRCA1/2 mutations. Design: - Participants will be screened with a basic medical history. - They will be asked general questions about their personal and family history. These include questions on marital and health insurance status, education, and income. - Those in the study will have a 45- to 60-minute phone interview. They will answer questions about how they told their family members about their genetic test results. They will also be asked what that experience was like.
The researchers have developed and distributed several software packages for pedigree analysis (FAST, CASPAR, PedHunter, IIC) and cancer genetics (oncotree, METREX). Users who need assistance with the software or who want to see new features added often send the researchers data files that include human data. The information is normally coded, and the researchers do not have access to the identification of the people whose information is in the files. Sometimes the content of the files gives rise to collaborations between the software developers and the providers of the files. Because concerns over the confidentiality of medical information have increased significantly over the past few years, the researchers must apply for exemptions from detailed ethics committee oversight for every data set they receive. This process is cumbersome and makes it difficult to assist software users. The amount of information required to apply for an exemption also poses a barrier to collaborations. A full protocol will subject all data sets to ethics committee oversight without the need for individual exemption requests, enabling the researchers to assist users with software problems and to collaborate with other researchers. From January 1, 2000, through December 15, 2001, the researchers received 71 requests for assistance, 19 of which included data files. None of the data files had any names or patient identifiers. Of these 19, in 8 cases the researchers sent back modified output files. In two of these eight cases, the researchers could see results of research interest; one of them concerned human data. In 2 of the 19 cases, the researchers sent back modified input files; in one such case, they established a collaboration with the originator of the files. In sum, most requests come under the heading of customer service, with no research contents. A few, however, do lead to research results or collaborations, for which ethics committee oversight is required. Over the three-year time frame of this protocol, the researchers anticipate receiving data on a maximum of 10,000 individuals. They have modified their software documentation to explicitly instruct users to make sure the data files they send have no names. Should they receive files with names, they will delete the files and ask the originator to resubmit them with names encoded. Users submit data through unencrypted e-mail. The data are stored in password-protected computers at the National Institutes of Health.