Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001468
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Outcomes of Education and Counseling for BRCA1 Testing
Sponsor:
National Human Genome Research Institute NHGRI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Outcomes of Education and Counseling for BRCA1 or BRCA2 Testing
Status:
COMPLETED
Status Verified Date:
2000-02
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:
This study will identify how personal beliefs values and family experiences affect a persons decision as to whether or not to be tested for changes in a gene called BRCA1 or BRCA2 Changes in these genes are associated with a significantly increased risk of breast and ovarian cancer in women a slightly higher risk of prostate cancer in men and a slightly higher risk of colon cancer in both men and women
Families enrolled in the National Cancer Institutes familial cancer research project who also participated in a telephone survey protocol 78-C-0039 regarding their level of interest in BRCA12 testing results may be eligible for this study
All participants will complete a 20- to 30-minute questionnaire assessing knowledge risk perception and personality traits and will participate in an education session to review the following
Information about their individual cancer risk based on family history
Potential benefits and risks medical psychological and social of BRCA12 testing both for those who test positive and those who test negative
Overview of DNA testing what is done and how accurate it may or may not be
Medical management options for those at increased risk for breast and ovarian cancer
Environmental cancer risk factors
Instruction in breast self-examination
Participants will then be asked whether or not they want to undergo BRCA12 testing
Those who want to be tested will be divided into two groups to compare counseling methods client-centered vs counselor-driven counseling A small blood sample 2 to 3 tablespoons will be drawn for genetic analysis Test results will be provided in person at a second visit-this may take 6 months or more A follow-up telephone call 2 weeks after receipt of the test results will address participants questions and provide support During a third visit scheduled 6 months after receipt of the test results participants will complete questionnaires evaluating mood attitude self-esteem family interactions cancer screening practices and other factors Finally 1 year after receipt of the test results participants will be contacted by telephone and asked about their feelings about the test and its outcome
Individuals who choose not to have gene testing will not participate in any in-person sessions after the initial visit They will be followed with no more than two telephone interviews to assess their feelings and attitudes related to their decision not to be tested
Individuals may reconsider and change their mind at any time regarding their decision-whether to be tested or not
The results of the study will help experts devise the most effective methods of educating and counseling people at high risk for having an altered BRCA12 gene
Families enrolled in the National Cancer Institutes familial cancer research project who also participated in a telephone survey protocol 78-C-0039 regarding their level of interest in BRCA12 testing results may be eligible for this study
All participants will complete a 20- to 30-minute questionnaire assessing knowledge risk perception and personality traits and will participate in an education session to review the following
Information about their individual cancer risk based on family history
Potential benefits and risks medical psychological and social of BRCA12 testing both for those who test positive and those who test negative
Overview of DNA testing what is done and how accurate it may or may not be
Medical management options for those at increased risk for breast and ovarian cancer
Environmental cancer risk factors
Instruction in breast self-examination
Participants will then be asked whether or not they want to undergo BRCA12 testing
Those who want to be tested will be divided into two groups to compare counseling methods client-centered vs counselor-driven counseling A small blood sample 2 to 3 tablespoons will be drawn for genetic analysis Test results will be provided in person at a second visit-this may take 6 months or more A follow-up telephone call 2 weeks after receipt of the test results will address participants questions and provide support During a third visit scheduled 6 months after receipt of the test results participants will complete questionnaires evaluating mood attitude self-esteem family interactions cancer screening practices and other factors Finally 1 year after receipt of the test results participants will be contacted by telephone and asked about their feelings about the test and its outcome
Individuals who choose not to have gene testing will not participate in any in-person sessions after the initial visit They will be followed with no more than two telephone interviews to assess their feelings and attitudes related to their decision not to be tested
Individuals may reconsider and change their mind at any time regarding their decision-whether to be tested or not
The results of the study will help experts devise the most effective methods of educating and counseling people at high risk for having an altered BRCA12 gene
Detailed Description:
Women at increased risk for developing breast andor ovarian cancer and their first degree relatives will be offered BRCA12 gene testing This study proposes to evaluate psychological and behavioral aspects of their decision-making and the outcomes of the testing process Knowledge and expectations will be assessed initially followed by pre-test psychological assessment and an in person education and counseling session Participants will be presented the choice of whether or not to undergo BRCA12 testing Notification of test results will occur in person along with discussion of available surveillance options Telephone interviews will assess psychological and behavioral outcome measures at 6 andor twelve month time points Aspects of this research endeavor have been designed to complement an NHGRINCI extramural consortium and an NHGRINCI intramural collaboration both of which will address various aspects of risk notification and follow-up for hereditary breast ovarian and colon cancer
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 95-HG-0085 | None | None | None |