Counseling Interventions for BRCA 1/2 Cancer Susceptibility Testing

2014-08-27 03:51:05 | BioPortfolio


To evaluate two different ways of providing information about genetic testing for BRCA1 and BRCA2 alterations. The two forms of counseling are genetic counseling and enhanced informed consent which cover similar material but are organized differently.


- Patients will have a blood sample drawn that will be analyzed for altered BRCA1 or BRCA2 genes. An alteration of BRCA1 or BRCA2 gene means there is an increased risk of developing breast and ovarian cancer.

- Patients participating in this study have either: 1) expressed an interest in testing for an underlying genetic factor that may account for the breast or ovarian cancer in their family; 2) have at least one relative that has been found to have a BRCA1 or BRCA2 alteration; 3) have a personal or family history of breast or ovarian cancer that is suggestive of a BRCA1 and BRCA2 alteration; or 4) has breast or ovarian cancer, or has at least one close relative with a history of breast or ovarian cancer and are a member of an ethnic group with increased frequency of BRCA1 and BRCA2 alterations.

- Patients will be randomized into one of two counseling groups. Two visits with a specially trained genetic counselor or nurse in conjunction with a medical oncologist and/or a medical specialist will be done in which information will be given either about genetic counseling or enhanced informed consent. These visits will be audio-taped to monitor how the project staff is covering the important information about testing.

- Throughout this study patients will be asked to complete questionnaires and psychological measures. These forms will be completed before and after the first visit, and a subset of them again at 2-4 weeks after the second visit, and at 4, 6, and 12 months.

- In addition 30 women will be asked to complete a 20-30 minute telephone interview with the program psychologist.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label


Breast Cancer


Genetic Counseling, Informed Consent Counseling


Dana-Farber Cancer Institute
United States


Active, not recruiting


Dana-Farber Cancer Institute

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:51:05-0400

Clinical Trials [8476 Associated Clinical Trials listed on BioPortfolio]

Genetic Testing for All Breast Cancer Patients (GET FACTS)

This study is designed to determine the impact of a novel genetic counseling method on surgical decisions in individuals with newly diagnosed breast cancer This research study involves an...

Improving Genetic Counseling for BRCA+ Mothers

Genetic counseling and testing for hereditary breast cancer may reveal that you, and possibly your blood relatives, are at increased risk for the disease across the lifespan. This includes...

Testing a Culturally Adapted Telephone Genetic Counseling Intervention

Participating in genetic cancer risk assessments (GCRA) for hereditary breast and ovarian cancer (HBOC) can inform treatment and risk management decisions and improve breast cancer outcome...

Written Genetic Counseling and Mutation Analysis of BRCA1 and BRCA2 to Patients With Breast Cancer

The overall purpose of the study is to evaluate a method for offering mutation analysis of BRCA1 and BRCA2 to all patients with newly diagnosed breast cancer, regardless of age at diagnosi...

Effects of Rapid Genetic Counseling and Testing in Newly Diagnosed Breast Cancer Patients

5-10% of breast cancer patients carry a mutation in the BRCA1 or BRCA2 gene. Genetic counseling and DNA testing are usually offered to selected patients after primary treatment has been co...

PubMed Articles [20609 Associated PubMed Articles listed on BioPortfolio]

Racial disparities in breast cancer hereditary risk assessment referrals.

For poorly understood reasons, Black non-Hispanic (BNH) women meeting National Comprehensive Cancer Network (NCCN) criteria for genetic testing for breast cancer risk are less likely than White non-Hi...

What men want: Qualitative analysis of what men with prostate cancer (PCa) want to learn regarding genetic referral, counseling, and testing.

Guidelines have changed recently to include genetic counseling (GC) and/or genetic testing (GT) for all men with aggressive prostate cancer (PCa). This study aimed to identify what information men wit...

When is it necessary to refer a child with cancer to genetic counseling?

In the past few years there is an emerging need for clinical genetics counseling in the case of malignant diseases as well. For these reasons a novel professional recommendation has been developed for...

Challenges and opportunities in genetic counseling for hereditary endocrine neoplasia syndromes.

The Genetic Counseling Workgroup from the 16th International Workshop on Multiple Endocrine Neoplasia Conference (MEN 2019) convened to discuss contemporary challenges and opportunities in the area of...

Experiencing genetic counseling at the undergraduate level: A course to enrich student horizons.

Medical and Biotech [MESH] Definitions

Counseling during which a professional plays an active role in a client's or patient's decision making by offering advice, guidance, and/or recommendations.

Counseling conducted via electronic or other non-face-to-face interactions.

Informed consent given by someone other than the patient or research subject.

Informed consent given by a parent on behalf of a minor or otherwise incompetent child.

An organized and comprehensive program of health care that identifies and reduces a woman's reproductive risks before conception through risk assessment, health promotion, and interventions. Preconception care programs may be designed to include the male partner in providing counseling and educational information in preparation for fatherhood, such as genetic counseling and testing, financial and family planning, etc. This concept is different from PRENATAL CARE, which occurs during pregnancy.

More From BioPortfolio on "Counseling Interventions for BRCA 1/2 Cancer Susceptibility Testing"

Quick Search

Relevant Topics

Bioinformatics is the application of computer software and hardware to the management of biological data to create useful information. Computers are used to gather, store, analyze and integrate biological and genetic information which can then be applied...

Breast Cancer
Track and monitor developments in breast cancer research and commercial development.  Follow the tabs above to read the latest global news, research, clinical trials on breast cancer and follow companies active in the development of breast cancer tr...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Searches Linking to this Trial