Evaluation of the Information Letter to Relatives in the Context of Genetic Assessments (LIPEG)

December 17, 2015 updated by: University Hospital, Bordeaux
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

325

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • CHRU de Montpellier - Hôpital Arnaud de Villeneuve
      • Rennes, France, 35203
        • CHU de RENNES - Hôpital Sud
      • Toulouse, France, 31059
        • CHU de Toulouse - Hôpital Purpan
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33000
        • University Hospital Bordeaux
      • Strasbourg, Aquitaine, France, 67080
        • Hôpital Universitaire de Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Other: Questionnaire after the reading of letter B.
Oral questionnaire after the reading of letter B.
Group 2a-public
75 persons belonging to general population.
Other: 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-).
Other: Questionnaire after the reading of letter B.
Oral questionnaire after the reading of letter B.
Other: 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).
Other: Questionnaire after the reading of letter B.
Oral questionnaire after the reading of letter B.
Other: 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.
Other: Questionnaire after the reading of letter B.
Oral questionnaire after the reading of letter B.
Other: Questionnaire after the reading of letters A and B
Oral questionnaire after the reading of letters A and B during individual interview.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Score of understanding questionnaire after reading letter B.
Time Frame: 1 day
1 day
Proportion of persons who prefer the letter B.
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Cécile ZORDAN, Ms, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

December 17, 2015

First Submitted That Met QC Criteria

December 17, 2015

First Posted (Estimate)

December 21, 2015

Study Record Updates

Last Update Posted (Estimate)

December 21, 2015

Last Update Submitted That Met QC Criteria

December 17, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2014/32

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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