Official Title: "A Qualitative Exploration of the Impact of Positive BRCA1/2 Mutation Status on the Lives of Young Women"
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.
- Study Type: Observational
- Study Design: N/A
- Study Primary Completion Date: December 2010
Detailed Clinical Trial Description
- 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.
Interventions Used in this Clinical Trial
- Behavioral: telephone-based intervention
- Other: questionnaire administration
- Procedure: psychosocial assessment and care
Outcome Measures for this Clinical Trial
- Qualitative information gathered
- Safety Issue?: No
Criteria for Participation in this Clinical Trial
- Completed genetic testing and received a positive test result (i.e., a deleterious or disease-related mutation identified) for BRCA1 or BRCA2
- Experienced or contemplating/planning couple relationship(s), formation of a family, and/or risk management/reduction strategies
- Meets ≥ 1 of the following criteria:
- Attended the Joining FORCEs 2009 Annual Conference in May 2009 (focus groups)
- Previously participated in the Clinical Genetics Branch of NCI Breast Imaging or Hereditary Breast/Ovarian Cancer studies
- Able to speak and understand English with a level of fluency sufficient for completion of a recorded telephone interview
- Willing to have interview digitally recorded
PRIOR CONCURRENT THERAPY:
- Not specified
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 35 Years
Are Healthy Volunteers Accepted for this Clinical Trial: No
Clinical Trial Investigator Information
- Lead Sponsor
- National Cancer Institute (NCI)
- Overall Official(s)
- Mark H. Greene, MD, Principal Investigator, Clinical Genetics Branch