Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165152
Status:
COMPLETED
Last Update Posted:
2012-08-09
First Post:
2005-09-09
Brief Title:
Counseling Interventions for BRCA 12 Cancer Susceptibility Testing
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Randomized Study of Counseling Interventions for BRCA 12 Cancer Susceptibility Testing
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None