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

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 )

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Key information

Conditions

Cancer Adnexal Diseases Breast Cancer Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Attributes Disease Susceptibility Endocrine Gland Neoplasms Endocrine System Diseases Fanconi Anemia, Complementation Group D1 Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Predisposition to Disease Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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 )

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Behaviour

Behavioral

Comparison to psychological, medical and emotional Influencing communication and achievement factors to Oncogenetics tests

Primary outcomes

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.
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.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study 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

Acronym: PSICOM

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2018
First posted: Mar 26, 2019
Registry last updated: Mar 28, 2019

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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Completed