Ignite Creation Date:
2024-05-06 @ 1:39 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01866865
Status:
COMPLETED
Last Update Posted:
2018-04-05
First Post:
2013-05-29
Brief Title:
Adaptation to Living With a BRCA12 Mutation
Sponsor:
National Human Genome Research Institute NHGRI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Adaptation to Living With a BRCA l2 Mutation in Carriers and Their Partners
Status:
COMPLETED
Status Verified Date:
2016-11-22
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
- Women who have a BRCA12 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 BRCA12 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 BRCA12 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 BRCA12 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
- Women who have a BRCA12 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 BRCA12 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 BRCA12 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 BRCA12 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
Detailed Description:
The proposed study aims to describe adaptation and dyadic adjustment in unaffected BRCA12 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 13-HG-N134 | None | None | None |