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NCT00858078 · ClinicalTrials.gov registry record
A Qualitative Exploration of the Impact of Positive BRCA1/2 Mutation Status on the Lives of Young Women
A clinical trial, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- 76
- Enrollment target
NCT00858078: Completed study, sponsored by National Cancer Institute (NCI).
NCT00858078 is a clinical trial that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 76 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00858078 has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- 76 participants
- Enrollment target
Study Summary
Background: * Mutations detected in the BRCA1 or BRCA2 genes have been show to produce very high risks of breast and ovarian cancer (as high as 90% and 60%, respectively), as well as accompanying risks for several other types of cancer. Women who have these genetic anomalies and who do not have cancer are aware of their high-risk status, which can have an effect on their ability to make decisions about personal choices and health care. * Researchers are interested in learning more about how people who know their cancer risk status make decisions on personal relationships, family formation, and risk-reduction options. Objectives: \- To study young women s experiences and decision-making processes regarding family history, genetic testing, couple relationships, family formation, and cancer risk management within the context of their experiences as BRCA1/2 mutation carriers. Eligibility: * Women between the ages of 18 and 35 years of age and older who have been identified as having a BRCA1 or BRCA2 mutation. Participants must be contemplating or have experienced couple relationships, family formation, and/or risk management and reduction. * Participants must be willing to have their interviews digitally recorded Design: * Researchers will conduct between 30 and 50 telephone interviews of study participants. Each interview will be approximately 90 minutes in length. The interview consists of open-ended questions that ask about the participants and their experiences before, during, and after they underwent genetic testing for BRCA1/2. * At least one focus group will be coordinated at a national conference for individuals who are aware of their genetically based cancer risk. If more than 25 individuals are interested in participating in the group, an additional focus group will be convened. * No medical treatments are specifically offered as a part of this study.
Primary Outcome
Conduct follow-up telephone interviews with participantswho were newly-tested at the time of original data collection to increase understanding of their mutationpositive experience longitudinally.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2011-06-21 |
| Est. Completion | 2015-04-03 |
What the finished NCT00858078 record still lists
NCT00858078 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 76 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00858078 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00858078 about?
NCT00858078 is a clinical study titled "A Qualitative Exploration of the Impact of Positive BRCA1/2 Mutation Status on the Lives of Young Women". Background: * Mutations detected in the BRCA1 or BRCA2 genes have been show to produce very high risks of breast and ovarian cancer (as high as 90% and 60%, respectively), as well as accompanying risks for several other types of cancer. Women who have these genetic anomalies and who do not have can...
What is the current status of trial NCT00858078?
This trial is currently completed. The enrollment target is 76 participants. The study started on 2011-06-21. Estimated completion is 2015-04-03.
Who is sponsoring clinical trial NCT00858078?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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