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OpenTrials
Completed

NCT Number: NCT01866865

Adaptation to Living With a BRCA1/2 Mutation

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.

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Key information

Conditions

Cancer Genetics

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Primary outcomes

  1. the primary outcome is psychological adaptation

    Time frame: 1 time survey

Sponsors and collaborators

Lead sponsor

National Human Genome Research Institute (NHGRI)

Nih

Collaborators

  • Johns Hopkins Bloomberg School of Public Health

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 3, 2013
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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