Information and Accompaniment of Siblings Following the Announcement of a Cancer in Pediatric Hematology.

December 4, 2025 updated by: University Hospital, Lille
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

Study Overview

Status

Terminated

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

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

      • Lille, France
        • Hôpital Jeanne de Flandres, CHU

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

6 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

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

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

  • 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

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

Investigators

  • Principal Investigator: Eva De Berranger, MD, University Hospital, Lille

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 (Actual)

October 22, 2018

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

March 8, 2017

First Submitted That Met QC Criteria

May 17, 2018

First Posted (Actual)

May 30, 2018

Study Record Updates

Last Update Posted (Actual)

December 11, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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