NCT03541330

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2017

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

October 22, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

December 11, 2025

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

March 8, 2017

Last Update Submit

December 4, 2025

Conditions

Keywords

Siblingsinformationmalignant haemopathy

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

OTHER

Brother or sister of a child has malignant haemopathy and follow-up in the pediatric hematology department

Other: semi-directive interview

Interventions

semi-structured interview conducted by a clinical psychologist

siblings

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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

Location

Study Officials

  • Eva De Berranger, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

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

Locations