Impact of Testing Positive for the BRCA1 or BRCA2 Mutation in Young Women Who Are BRCA1 or BRCA2 Mutation Carriers
Recruitment status was Recruiting
RATIONALE: Gathering information from women who are BRCA1 or BRCA2 mutation carriers may help doctors learn how they manage cancer risk and meet the challenges of young adulthood.
PURPOSE: This clinical trial is studying the impact of testing positive for the BRCA1/2 mutation in young women who are BRCA1 or BRCA2 mutation carriers.
brca1 Mutation Carrier
brca2 Mutation Carrier
Sexuality and Reproductive Issues
Behavioral: telephone-based intervention
Other: questionnaire administration
Procedure: psychosocial assessment and care
|Official Title:||A Qualitative Exploration of the Impact of Positive BRCA1/2 Mutation Status on the Lives of Young Women|
- Qualitative information gathered [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
- Recruit 30-50 BRCA1/2-positive women aged 18-35 to participate in a semi-structured, qualitative methods interview study.
- Facilitate focus group including additional mutation-positive women (n = 25-50) to provide feedback regarding results and analyses.
- Increase knowledge of young women's experiences in navigating the tasks and challenges of young adulthood, within the context of their experiences as BRCA1/2 mutation carriers, including family history, genetic testing, couple relationships, family formation, and cancer risk management.
- Verify new information via focus groups with other mutation-positive individuals.
- Disseminate new knowledge via professional presentations and publications.
OUTLINE: Participants undergo telephone interviews for approximately 90 minutes, comprising open-ended questions about demographic information and personal history of cancer; four questions about the history of cancer in their families; experiences with genetic testing; couple relationships, including experiences with disclosure of positive mutation status to past, current, and/or future partners; nexus of experiences as mutation-positive and their plans regarding family creation; and questions regarding the use of cancer risk-management and risk-reducing strategies for qualitative analysis of couple and family treatment strategies. Participants also undergo focus group sessions in-person at the Joining FORCEs conference.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00954239
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office||Recruiting|
|Bethesda, Maryland, United States, 20892-1182|
|Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937|
|Principal Investigator:||Mark H. Greene, MD||Clinical Genetics Branch|