Trial record 106 of 200 for:    NHGRI

Adaptation to Living With a BRCA1/2 Mutation

This study has been completed.
Sponsor:
Collaborator:
Johns Hopkins Bloomberg School of Public Health
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )
ClinicalTrials.gov Identifier:
NCT01866865
First received: May 29, 2013
Last updated: March 24, 2015
Last verified: February 2015
  Purpose

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.

Condition
Cancer Genetics

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Adaptation to Living With a BRCA l/2 Mutation in Carriers and Their Partners

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • the primary outcome is psychological adaptation [ Time Frame: 1 time survey ] [ Designated as safety issue: No ]

Estimated Enrollment: 460
Study Start Date: May 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01866865

Locations
United States, Maryland
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Investigators
Principal Investigator: Barbara B Biesecker National Human Genome Research Institute (NHGRI)
  More Information

Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )
ClinicalTrials.gov Identifier: NCT01866865     History of Changes
Other Study ID Numbers: 999913134, 13-HG-N134
Study First Received: May 29, 2013
Last Updated: March 24, 2015
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
BRCA1
BRCA2

ClinicalTrials.gov processed this record on May 21, 2015