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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01866865
• Other study ID #: 999913134
• Secondary ID: 13-HG-N134
• Status: Completed
• First received: May 29, 2013
• Last updated: April 4, 2018
• Start date: May 2, 2013
• Est. completion date: February 20, 2014

Study information

• Verified date: November 22, 2016
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: February 20, 2014
• Est. primary completion date: February 20, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

• INCLUSION AND EXCLUSION CRITERIA:

Participants will be women aged 18 or older who have a BRCA1/2 mutation and their (male or female) partners. Carriers must have no personal history of cancer, but partners will not be excluded based on cancer history. Participants will be asked to disclose their mutation status (BRCA1 or BRCA2), but no screening evaluation will be required. If only one member of a couple completes the survey, their data will be included in the individual level analysis, but excluded from the dyadic level analysis.

Related Conditions & MeSH terms

• Cancer Genetics

Locations

Country	Name	City	State
United States	Johns Hopkins Bloomberg School of Public Health	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
National Human Genome Research Institute (NHGRI)	Johns Hopkins Bloomberg School of Public Health

Country where clinical trial is conducted

United States, 

References & Publications (1)

Berg CA, Upchurch R. A developmental-contextual model of couples coping with chronic illness across the adult life span. Psychol Bull. 2007 Nov;133(6):920-54. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the primary outcome is psychological adaptation		1 time survey