Evaluation of the Information Letter to Relatives in the Context of Genetic Assessments (LIPEG)
Study Overview
Status
Detailed Description
The recent publication of the decree of June 20th 2013 (n° 2013-527) suggests a protocol regarding the transmission of information of the relatives after genetic diagnosis of a serious condition allowing preventative or care measures. In the case a mutation career refuses to directly inform other members of his family, option is to call on services of a genetic professional for the transmission of its family information. This decree includes a specific model of letter that can be sent to relatives by genetic professionals.
The main objective of the present study is the standardization of the procedure concerning the information to relatives by all genetic professionals. It would allow the same format of information in all families involved.
The first part (study 1a) evaluated the understanding and feelings after the reading of the decree's letter (letter A) on patients and the public, through the use of an individual and oral questionnaire. Interviews with the patients, public, genetic professionals and people who have received this letter completed the study 1a (study 1b). A focus group (accounting different genetic professionals and patient associations) composed a new version of letter (letter B) through these observations (study 1c).
The second part will compare the two letters model (A vs B) impact through precise items on three populations: patients, public and genetic professionals. This study will allow to:
- Evaluate how the letter composed by the focus group (letter A) is understood and perceived by the patients and the public with the same methodology as study 1a (study 2a) ;
- Compare the two letters model (A vs B) to describing the preference of patients, public and genetic professionals (study 2b).
The expected results would help us to choose the letter accommodating as many people as possible to standardize practices.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Montpellier, France, 34295
- CHRU de Montpellier - Hôpital Arnaud de Villeneuve
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Rennes, France, 35203
- CHU de Rennes - Hôpital Sud
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Toulouse, France, 31059
- CHU de Toulouse - Hôpital Purpan
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Aquitaine
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Bordeaux, Aquitaine, France, 33000
- University Hospital Bordeaux
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Strasbourg, Aquitaine, France, 67080
- Hôpital Universitaire de Strasbourg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- Group 2a-patient: 75 patients who attended a genetic counselling consultation.
- Group 2a-public: 75 persons belonging to the general population who never attended genetic counselling consultation.
- Group 2b-patient: 75 patients who attended a genetic counselling consultation.
- Group 2b-public: 75 persons belonging to general population who never attendeda genetic counselling consultation. These persons are different than persons from group 2a-person.
- Group 2b-professionnal: 75 genetic professionals (geneticist and genetic counsellor).
Description
Inclusion Criteria:
- 18 years old and above
- French native speaker
- informed person
- person whose non-opposition has been received
- public: person who never attended a genetic counselling consultation
- professional: geneticist and genetic counsellors working in France
Exclusion Criteria:
- study 2a : person who took part of study 2b
- study 2b : person who took part of study 2a
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group 2a-patient
75 patients who attended a genetic counselling consultation.
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Oral questionnaire after the reading of letter B.
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Group 2a-public
75 persons belonging to general population.
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Oral questionnaire after the reading of letter B.
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Group 2b-patient
75 patients who attended a genetic counselling consultation (those patients are different than patients from group 2a-).
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Oral questionnaire after the reading of letter B.
Oral questionnaire after the reading of letters A and B during individual interview.
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Group 2b-public
75 persons belonging to general population (those persons are different than patients from group 2a).
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Oral questionnaire after the reading of letter B.
Oral questionnaire after the reading of letters A and B during individual interview.
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|
Group 2b-professional
75 genetic professionals.
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Oral questionnaire after the reading of letter B.
Oral questionnaire after the reading of letters A and B during individual interview.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Score of understanding questionnaire after reading letter B.
Time Frame: 1 day
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1 day
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Proportion of persons who prefer the letter B.
Time Frame: 1 day
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1 day
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cécile ZORDAN, Ms, University Hospital, Bordeaux
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2014/32
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