Adaptation to Living With a BRCA1/2 Mutation

NCT01866865 | Completed

• 2 other identifiers: 99991313413-HG-N134
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer Genetics

Keywords

BRCA1; BRCA2

Outcome Measures

Primary Outcomes (1)

• the primary outcome is psychological adaptation

  1 time survey

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Human Genome Research Institute (NHGRI): lead
• Johns Hopkins Bloomberg School of Public Health: collaborator

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, United States

Location

Related 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. doi: 10.1037/0033-2909.133.6.920.

  PMID: 17967089 BACKGROUND

Study Officials

• Barbara B Biesecker

  National Human Genome Research Institute (NHGRI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: June 3, 2013
• Study Start: May 2, 2013
• Primary Completion: February 20, 2014
• Study Completion: February 20, 2014
• Last Updated: April 5, 2018

Record last verified: 2016-11-22

Locations

US (1)