Impact of Testing Positive for the BRCA1 or BRCA2 Mutation in Young Women Who Are BRCA1 or BRCA2 Mutation Carriers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00954239
First received: August 6, 2009
Last updated: April 6, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention
brca1 Mutation Carrier
brca2 Mutation Carrier
Sexuality and Reproductive Issues
Behavioral: telephone-based intervention
Other: questionnaire administration
Procedure: psychosocial assessment and care

Study Type: Observational
Official Title: A Qualitative Exploration of the Impact of Positive BRCA1/2 Mutation Status on the Lives of Young Women

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Qualitative information gathered [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2009
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954239

Locations
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      
Sponsors and Collaborators
Investigators
Principal Investigator: Mark H. Greene, MD Clinical Genetics Branch
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00954239     History of Changes
Other Study ID Numbers: CDR0000634213, NCI-09-C-0074, NCI-P08477
Study First Received: August 6, 2009
Last Updated: April 6, 2010
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
sexuality and reproductive issues
BRCA1 mutation carrier
BRCA2 mutation carrier

ClinicalTrials.gov processed this record on October 01, 2014