Evaluation of the Information Letter to Relatives in the Context of Genetic Assessments
NCT ID: NCT02636543
Last Updated: 2015-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
325 participants
OBSERVATIONAL
2015-06-30
2015-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 2a-patient
75 patients who attended a genetic counselling consultation.
Questionnaire after the reading of letter B.
Oral questionnaire after the reading of letter B.
Group 2a-public
75 persons belonging to general population.
Questionnaire after the reading of letter B.
Oral questionnaire after the reading of letter B.
Group 2b-patient
75 patients who attended a genetic counselling consultation (those patients are different than patients from group 2a-).
Questionnaire after the reading of letter B.
Oral questionnaire after the reading of letter B.
Questionnaire after the reading of letters A and B
Oral questionnaire after the reading of letters A and B during individual interview.
Group 2b-public
75 persons belonging to general population (those persons are different than patients from group 2a).
Questionnaire after the reading of letter B.
Oral questionnaire after the reading of letter B.
Questionnaire after the reading of letters A and B
Oral questionnaire after the reading of letters A and B during individual interview.
Group 2b-professional
75 genetic professionals.
Questionnaire after the reading of letter B.
Oral questionnaire after the reading of letter B.
Questionnaire after the reading of letters A and B
Oral questionnaire after the reading of letters A and B during individual interview.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Questionnaire after the reading of letter B.
Oral questionnaire after the reading of letter B.
Questionnaire after the reading of letters A and B
Oral questionnaire after the reading of letters A and B during individual interview.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 2b : person who took part of study 2a
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Bordeaux
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Cécile ZORDAN, Ms
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital Bordeaux
Bordeaux, Aquitaine, France
Hôpital Universitaire de Strasbourg
Strasbourg, Aquitaine, France
CHRU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, , France
CHU de Rennes - Hôpital SUD
Rennes, , France
CHU de Toulouse - Hôpital Purpan
Toulouse, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CHUBX 2014/32
Identifier Type: -
Identifier Source: org_study_id