Counseling Interventions for BRCA 1/2 Cancer Susceptibility Testing

Breast Cancer Clinical Trial

Official title: A Randomized Study of Counseling Interventions for BRCA 1/2 Cancer Susceptibility Testing

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

• 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, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Cancer
• Disease Susceptibility
• Ovarian Cancer

• NCT number: NCT00165152
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Status: Completed
• Phase: N/A
• Start date: July 1998
• Completion date: June 2005