Questionnaire after the reading of letter B.
OtherOral questionnaire after the reading of letter B.
Completed
NCT Number: NCT02636543
Evaluation of the Information Letter to Relatives in the Context of Genetic Assessments
The decree of June 20th 2013 (n° 2013-527) suggests a protocol regarding the transmission of information to the relatives after genetic diagnosis of a serious condition. This decree includes a specific model of letter that can be sent to relatives by genetic professionals. We evaluated the understanding and feelings after the reading of the decree's letter (letter A) on patients and the public. A focus group drafted a new version of the letter (letter B) through these observations. The two letter models (A vs B) are compared in terms of impact through precise items (understanding and feelings) on three populations: patients, public and genetic professionals. Assumption is made that the letter B will be preferred to the letter A. Overall, we aim at giving a letter formulation accommodating as many people as possible to standardize practices.
Completed
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Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
University Hospital Bordeaux, Bordeaux, Aquitaine, France
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About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Questionnaire after the reading of letters A and B
OtherOral questionnaire after the reading of letters A and B during individual interview.
Primary outcomes
-
Score of understanding questionnaire after reading letter B.
Time frame: 1 day
-
Proportion of persons who prefer the letter B.
Time frame: 1 day
Sponsors and collaborators
Lead sponsor
University Hospital, Bordeaux
Other
Registry information
Acronym: LIPEG
Important dates
- Study start
- 2015
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Dec 21, 2015
- Registry last updated
- Dec 21, 2015
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.