Adaptation to Living With a BRCA1/2 Mutation

Cancer Genetics Clinical Trial

Official title: Adaptation to Living With a BRCA l/2 Mutation in Carriers and Their Partners

Status Completed

Clinical Trial Summary

Background:

• Women who have a BRCA1/2 gene mutation have a very high risk of developing breast or ovarian cancer. They are also at increased risk of other developing other cancers. Male carriers are at increased risk for breast, prostate and other cancers. Testing for this mutation and living with this increased risk can be a source of stress for both people with the mutation and their partners. Researchers want to look at how well people adapt to living with this type of cancer risk over time.

Objectives:

• To see how women with the BRCA1/2 gene mutation and their partners adapt to the stress of long-term cancer risk.

Eligibility:

• Women at least 18 years of age who have a BRCA1/2 mutation, and their male or female partners.

Design:

• This study involves a one-time self-administered questionnaire. Participants will be recruited from local and national hereditary cancer support groups and cancer centers.

• There are two versions of the survey. One is for the woman with the BRCA1/2 gene mutation. The other is for her partner.

• The survey will ask about risk perception, cancer worry, risk-related stress, and coping and adaptation methods.

• Treatment will not be provided as part of this study.

Clinical Trial Description

The proposed study aims to describe adaptation and dyadic adjustment in unaffected BRCA1/2 carriers and their partners. It is not fully understood how women and their partners adapt to highrisk status over time, nor how different aspects of living at risk relate to this process. Neither psychological adaptation nor dyadic adjustment has been systematically measured in this population. This study is informed by Lazarus & Folkman s Transactional Model of Stress and Coping and modifications made to this model for use in studying dyadic relationships. A crosssectional research design will quantitatively explore the relationships between the appraisals and timing of risk-related stressors, dyadic coping, and the outcomes of adaptation and dyadic adjustment. Participants will be recruited from hereditary breast and ovarian cancer (HBOC) support groups, website postings, listservs, and clinic patient lists. They will have the option of completing either a paper or online version of the survey. ;

Related Conditions & MeSH terms

• Cancer Genetics

• NCT number: NCT01866865
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Status: Completed
• Start date: May 2, 2013
• Completion date: February 20, 2014