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

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ClinicalTrials.gov Identifier: NCT03889171
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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Brief 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 )

Condition or disease Intervention/treatment
Cancer Colorectal Cancer Breast Cancer Ovarian Cancer Behavioral: Behaviour

Detailed 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 )
Study Design
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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : August 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


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

Outcome Measures
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Primary Outcome Measures :
  1. intrafamilial disclosure rate [ Time Frame: On average 1 year ]
    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.

  2. relatives' genetic targeted testing uptake rate [ Time Frame: On average 1 year ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
female and male participants are being studied
Criteria

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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03889171    
Other Study ID Numbers: 8893
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
genetic testing
genes BRCA1
genes BRCA2
mutation
family
disclosure
 psychology
DNA mismatch repair
genetic predisposition to disease
cancer
oncology
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases