Protocol Number: 09-C-0074

Title:

A Qualitative Exploration of the Impact of Positive BRCA 1/2 Mutation Status on the Lives of Young Women

Number:

09-C-0074

Summary:

Background:

-BRCA1/2 mutations are present in approximately 1 in 800 individuals in the US, with higher frequency among some populations (e.g., Ashkenazi Jews)

-Mutations confer a lifetime breast cancer risk approaching 90%, ovarian cancer risk as high as 60%, and lesser increases in absolute risks of selected other cancers (e.g., male breast, prostate, pancreas).

-Breast/Ovarian Cancer Pre-Vivors have not been diagnosed with cancer, but are aware of their high risk of developing cancer due to an inherited mutation.

-Research on the experiences of young women, who face multiple challenges related to normative development in the context of their mutation-positive status, is scarce.

--Breast/Ovarian Cancer Risk Perception: integral to decision-making, influenced by family cancer history

--Couple Relationships: Anxiety re: finding a partner, disclosing mutation status, anticipatory loss

--Family Formation: Pressure of societal, family, and relationship expectations and complicated overlap of issues between childbearing and cancer risk

--Risk-management and -reduction: Options include surveillance, chemoprevention, and surgery; physician recommendations vary and no strategy eliminates risk.

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.

Eligibility:

-Age 18-35

-Able to speak/understand English fluently

-Tested positive for a deleterious mutation in BRCA1 or BRCA2

-Contemplating or having experienced couple relationships, family formation, and/or risk management/reduction

-Willing to have interview digitally recorded

Design:

-30-50 telephone interviews; 1-2 focus group sessions, each with max. 25 participants

-Cohort interview study

-Digitally-recorded telephone interviews stored and transcribed electronically

-Analyzed using modified grounded theoretical design, QSR NVivo 2.0 software

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Female

Referral Letter Required: No

Population Exclusion(s): Children

Male

Eligibility Criteria:

INCLUSION CRITERIA:

-Participants must be biologically female

-Participants must have reached their 18th birthday but not have passed their 35th birthday

-Participants must be able to speak and understand English with a level of fluency sufficient for completion of the recorded telephone interview

-Participants must have completed genetic testing for BRCA1/2 and received a positive test result (i.e., a deleterious or disease-related mutation was identified).

-Participants must have experienced or be contemplating/planning couple relationship(s), formation of a family, and/or utilization of risk management/reduction strategies at some point.

EXCLUSION CRITERIA:

-Potential participants will be excluded from the study if they do not agree to have their interview or focus group contributions audio recorded.

Special Instructions:

Currently Not Provided

Keywords:

Qualitative Research

Semi-Structured Telephone Interview

BRCA-1/2

Psychosocial/Behavioral Research

Hereditary Cancer Risk

Recruitment Keyword(s):

None

Condition(s):

BRCA2 Gene

BRCA1 Gene

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):

Engel GL. The need for a new medical model: a challenge for biomedicine. Science. 1977 Apr 8;196(4286):129-36.

Engel GL. The clinical application of the biopsychosocial model. Am J Psychiatry. 1980 May;137(5):535-44.

Lynch HT, Leibowitz R, Smyrk T, Fusaro RM, Lynch JF, Smith A, Franklin B, Stella A, Liu B. Colorectal cancer and the Muir-Torre syndrome in a Gypsy family: a review. Am J Gastroenterol. 1999 Mar;94(3):575-80

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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