- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03541330
Information and Accompaniment of Siblings Following the Announcement of a Cancer in Pediatric Hematology.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lille, France
- Hôpital Jeanne de Flandres, CHU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children from 6 to 12 years old
- Brother or sister of a child:
O has malignant haemopathy O follow-up in the pediatric hematology department in Lille, O diagnosed from 6 weeks to 1 year before maintenance of the healthy subject included
- whose parents are able to understand and sign voluntarily informed consent
- Affiliated to a social security scheme
- Ability to understand and answer questions alone during the semi-structured interview
Exclusion Criteria:
- Child under 6 years or over 12 years
- Subject with a pathology that may interfere with the course of the study, according to the investigator's assessment
- Absence of the informed consent of one of the parents and / or the legal representative
- Refusal of participation of the subject
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: siblings
Brother or sister of a child has malignant haemopathy and follow-up in the pediatric hematology department
|
semi-structured interview conducted by a clinical psychologist
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Level of satisfaction and characteristics of information received about the disease by healthy siblings of children with hematological malignancies
Time Frame: 1 year
|
Measure Qualitative Interviews by Grounded theory. The experience with the information received on the disease by the healthy brothers and sisters of childrens with malignant haemopathy. Assessment of the level of satisfaction with the information received. The information will be characterized according to three dimensions: the framework (by whom, with whom, where, when, how) and the content of the information |
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Explore the representations of the disease in healthy siblings
Time Frame: 1 year
|
The representation of the disease is the set of personal beliefs of an individual about the disease.
It allows him to make sense of the disease.
These data will be analyzed during the semi-structured interview
|
1 year
|
|
Evaluate their information and support needs following the announcement of the disease
Time Frame: 1 year
|
information and support needs gathered during the semi-structured interview
|
1 year
|
|
Identify the possible psychic and social consequences of the disease in these healthy subjects
Time Frame: 1 year
|
to identify during the semi-directive interview the elements informing about the social behavior and the psychic state of the subject included, expressed spontaneously by the subject, directly (in the speech, for example "I am sad") or indirectly (by attitude, for example: crying)
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eva De Berranger, MD, University Hospital, Lille
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2016_83
- 2016-A02091-50 (Other Identifier: ID-RCB Number, ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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