NCT03889171

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 )

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

2.1 years

First QC Date

March 11, 2019

Last Update Submit

March 26, 2019

Conditions

Keywords

genetic testinggenes BRCA1genes BRCA2mutationfamilydisclosurepsychologyDNA mismatch repairgenetic predisposition to diseasecanceroncology

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Interventions

BehaviourBEHAVIORAL

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

female and male participants are being studied

You may qualify if:

  • 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 )

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

NeoplasmsColorectal NeoplasmsBreast NeoplasmsOvarian NeoplasmsFanconi Anemia, Complementation Group D1Genetic Predisposition to Disease

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersDisease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2019

First Posted

March 26, 2019

Study Start

August 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2018

Last Updated

March 28, 2019

Record last verified: 2019-03