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A Qualitative Exploration of the Impact of Positive BRCA1/2 Mutation Status on the Lives of Young Women


N/A
18 Years
35 Years
Open (Enrolling)
Female
brca1 Mutation Carrier, brca2 Mutation Carrier, Sexuality and Reproductive Issues

Thank you

Trial Information

A Qualitative Exploration of the Impact of Positive BRCA1/2 Mutation Status on the Lives of Young Women


OBJECTIVES:

- 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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

- 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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Qualitative information gathered

Safety Issue:

No

Principal Investigator

Mark H. Greene, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Clinical Genetics Branch

Authority:

Unspecified

Study ID:

CDR0000634213

NCT ID:

NCT00954239

Start Date:

January 2009

Completion Date:

Related Keywords:

  • brca1 Mutation Carrier
  • brca2 Mutation Carrier
  • Sexuality and Reproductive Issues
  • sexuality and reproductive issues
  • BRCA1 mutation carrier
  • BRCA2 mutation carrier

Name

Location
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office Bethesda, Maryland  20892-1182