Study Stopped
default of inclusion
Information and Accompaniment of Siblings Following the Announcement of a Cancer in Pediatric Hematology.
2 other identifiers
interventional
7
1 country
1
Brief Summary
The primary objective is to evaluate the experience with the information received on the disease by the healthy brothers and sisters of childrens with malignant haemopathy at the Centre Hospitalier Régional et Universitaire of Lille
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2017
CompletedFirst Posted
Study publicly available on registry
May 30, 2018
CompletedStudy Start
First participant enrolled
October 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedDecember 11, 2025
December 1, 2025
5 months
March 8, 2017
December 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Level of satisfaction and characteristics of information received about the disease by healthy siblings of children with hematological malignancies
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 Outcomes (3)
Explore the representations of the disease in healthy siblings
1 year
Evaluate their information and support needs following the announcement of the disease
1 year
Identify the possible psychic and social consequences of the disease in these healthy subjects
1 year
Study Arms (1)
siblings
OTHERBrother or sister of a child has malignant haemopathy and follow-up in the pediatric hematology department
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Jeanne de Flandres, CHU
Lille, France
Study Officials
- PRINCIPAL INVESTIGATOR
Eva De Berranger, MD
University Hospital, Lille
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2017
First Posted
May 30, 2018
Study Start
October 22, 2018
Primary Completion
April 1, 2019
Study Completion
April 1, 2019
Last Updated
December 11, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share