Adaptation to Living With a BRCA1/2 Mutation

April 4, 2018 updated by: National Human Genome Research Institute (NHGRI)

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

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

142

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States
        • Johns Hopkins Bloomberg School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the primary outcome is psychological adaptation
Time Frame: 1 time survey
1 time survey

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Human Genome Research Institute (NHGRI)

Collaborators

Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 2, 2013

Primary Completion (Actual)

February 20, 2014

Study Completion (Actual)

February 20, 2014

Study Registration Dates

First Submitted

May 29, 2013

First Submitted That Met QC Criteria

May 29, 2013

First Posted (Estimate)

June 3, 2013

Study Record Updates

Last Update Posted (Actual)

April 5, 2018

Last Update Submitted That Met QC Criteria

April 4, 2018

Last Verified

November 22, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 999913134
  • 13-HG-N134

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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