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NCT00001468 · ClinicalTrials.gov registry record
Outcomes of Education and Counseling for BRCA1 Testing
A clinical trial, sponsored by National Human Genome Research Institute (NHGRI).
- Completed
- Registry status
- 1,500
- Enrollment target
NCT00001468: Completed study, sponsored by National Human Genome Research Institute (NHGRI).
NCT00001468 is a clinical trial that has completed, run by National Human Genome Research Institute (NHGRI). The registered enrollment target is 1,500 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001468 has completed, sponsored by National Human Genome Research Institute (NHGRI).
- COMPLETED
- Registry status
- 1,500 participants
- Enrollment target
Study Summary
This study will identify how personal beliefs, values and family experiences affect a person's 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 Institute's familial cancer research project who also participated in a telephone survey (protocol 78-C-0039) regarding their level of interest in BRCA1/2 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 BRCA1/2 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 BRCA1/2 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, f
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,500 participants |
| Start Date | 1995-03 |
| Est. Completion | 2001-02 |
What the finished NCT00001468 record still lists
NCT00001468 is an observational study that tracks outcomes without assigning an intervention. Its 1,500 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT00001468 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00001468 about?
NCT00001468 is a clinical study titled "Outcomes of Education and Counseling for BRCA1 Testing". This study will identify how personal beliefs, values and family experiences affect a person's 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 sl...
What is the current status of trial NCT00001468?
This trial is currently completed. The enrollment target is 1,500 participants. The study started on 1995-03. Estimated completion is 2001-02.
Who is sponsoring clinical trial NCT00001468?
This trial is sponsored by National Human Genome Research Institute (NHGRI), which has 185 total clinical trials registered on ClinicalTrials.gov.
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