Comparison to Psychological, Medical and Emotional Influencing Communication and Achievement Factors to Oncogenetics Tests

Breast Cancer Clinical Trial

— PSICOM  

Official title:

Predisposition to Breast Cancer BRCA1 / BRCA2 and to HNPCC Colon : Comparison to Psychological, Medical and Emotional Influencing Communication and Achievement Factors to Oncogenetics Tests

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03889171
• Other study ID #: 8893
• Status: Completed
• Start date: August 2012
• Est. completion date: September 2018

Study information

• Verified date: March 2019
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the study was to analyze the psychological and emotional determinants of domestic dissemination of information about genetic risk of cancer and to compare the level of diffusion syndromes in breast/ ovarian cancer ( BRCA1 / BRCA2) and colon/endometrial ( HNPCC )

Description:

The risk associated with a genetic predisposition is among the various forms of risk, the strongest identifiable risk . It enables to offer people at risk an appropriate medical care (screening, prevention ) the clinical benefit is validated today. The person with whom a predisposing mutation has been identified must communicated its related information on the risk of cancer and the ability to perform genetic analysis. It appears that this dissemination of information is not always optimal, as shown in figures from the National Cancer Institute joined the project; the purpose of the study was to analyze the psychological and emotional determinants of domestic dissemination of information about genetic risk of cancer and to compare the level of diffusion syndromes in breast/ ovarian cancer ( BRCA1 / BRCA2) and colon/endometrial ( HNPCC )

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2018
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient having a deleterious genetic mutation on genes BRCA1 and/or BRCA2 and or on genes MMR

• The patient being of the family (who carried out a full analysis of BRCA1/BRCA2 and/or those MMR )

Exclusion Criteria:

• Patient not carrying a deleterious genetic mutation on the BRCA1/2 genes and/or those of the MMR system,

• Patient under guardianship, curator or unable to give his non-opposition,

• Adult patients protected by law.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer
• Colorectal Cancer
• Colorectal Neoplasms
• Ovarian Cancer

Intervention

Behavioral:
• Behaviour
Comparison to psychological, medical and emotional Influencing communication and achievement factors to Oncogenetics tests

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intrafamilial disclosure rate	The intrafamilial disclosure rate assessed the number of relatives informed by the proband about the mutation (according to the proband) out of the number of relatives at risk of carrying the familial mutation. Relatives who were considered "at risk" were first, second, third or fourth-degree relatives, older than 18 years and related to the relevant side of the family or, if unknown, just related to the proband whatever the family side.	On average 1 year
Primary	relatives' genetic targeted testing uptake rate	The relatives' genetic targeted testing uptake rate assessed the number of relatives considered by the proband to have taken up the genetic targeted testing out of the number of relatives informed by the proband. To assess the potential bias of the proband's perception of genetic targeted testing uptake by relatives, we compared the number of relatives who underwent genetic targeted testing according to the proband with the number of tests actually performed. This anonymous comparison was performed in a subset of the population within the geographic regional area of Montpellier where all analyses are centralized in a single laboratory. Probands were asked how many relatives living in the region underwent genetic testing and this number was compared with the information available from the University Laboratory of Montpellier.	On average 1 year