Hereditary Breast-Ovarian Cancer is most often attributed to a genetic mutation in the BRCA1 or BRCA2 gene (BRCA+), conferring a significantly increased risk for breast and ovarian cancer. In mutation carriers these cancers often occur at an earlier age than in women with sporadic cancers. Prophylactic surgeries including bilateral prophylactic mastectomy (BPM) and bilateral prophylactic salpingo-oophorectomy (BPSO) are utilized to substantially decrease cancer risk. Chemoprevention with tamoxifen or raloxifene is another risk-reducing option. Unaffected BRCA+ women, without a personal history of cancer, face complex decisions regarding elective surgical procedures which are irreversible and not without risk. Outcome data on cancer risk reduction subsequent to prophylactic surgery or chemoprevention are available. However, research on the psychosocial implications is limited, particularly in the unaffected BRCA+ population in the United States. To contribute to our limited knowledge of the psychosocial sequela of risk-reducing surgeries an exploratory cross-sectional study is proposed. The intent of this research is to investigate sexual functioning, quality of life, anxiety, depression and the level of satisfaction with risk management decisions. A total of 400 BRCA+ unaffected women age <50 years will be recruited: 200 who have completed any prophylactic, risk-reducing surgery and 200 women who have elected not to have surgery. The specific research aims are to: 1) compare socio- demographics, sexual functioning, quality of life, anxiety and depression differences between BRCA+ women electing any prophylactic, risk-reducing surgery (BPM and/or BPSO) and those who do not choose surgery, 2) determine the level of satisfaction with risk management based on the choice for prophylactic, risk-reducing surgery (BPM and/or BPSO), chemoprevention, and/or increased clinical surveillance, and 3) examine the potential mediating role of sexual functioning on quality of life, anxiety, depression and the level of satisfaction. Study participants will complete the research instruments online. Data analysis will be conducted with descriptive statistics, ANOVA, correlation, multilevel modeling and structural equation modeling. Resulting data will provide a foundation for future biobehavioral research focused on disease prevention and quality of life in women at risk for Hereditary Breast-Ovarian Cancer. It is anticipated the findings will contribute to the development of interventions appropriate for education, psychosocial support and symptom management in this high-risk population.

Public Health Relevance

Inherited mutations in the BRCA gene dramatically increase the risk of breast and ovarian cancer. This research is to investigate sexual functioning, quality of life, anxiety, depression and satisfaction level in women with a BRCA mutation who have not had cancer. The study will compare women who have had prophylactic, risk-reducing surgery with those who have not had surgery. The research findings will enhance our knowledge of the potential side effects of risk-reducing surgeries. This information is important for decision-making related to risk reduction, disease prevention and quality of life in this high-risk group.

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Predoctoral Individual National Research Service Award (F31)
Project #
5F31NR012341-02
Application #
8117069
Study Section
National Institute of Nursing Research Initial Review Group (NRRC)
Program Officer
Banks, David
Project Start
2010-07-12
Project End
2012-07-11
Budget Start
2011-07-12
Budget End
2012-07-11
Support Year
2
Fiscal Year
2011
Total Cost
$30,566
Indirect Cost
Name
University of South Florida
Department
Type
Schools of Nursing
DUNS #
069687242
City
Tampa
State
FL
Country
United States
Zip Code
33612