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

Sponsor
University Hospital, Lille (Other)
Overall Status
Recruiting
CT.gov ID
NCT03541330
Collaborator
(none)
23
1
1
47.3
0.5

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: semi-directive interview
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
23 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Information and Accompaniment of Siblings Following the Announcement of a Cancer in Pediatric Hematology.
Actual Study Start Date :
Oct 22, 2018
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: siblings

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

Other: semi-directive interview
semi-structured interview conducted by a clinical psychologist

Outcome Measures

Primary Outcome Measures

  1. Level of satisfaction and characteristics of information received about the disease by healthy siblings of children with hematological malignancies [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

Secondary Outcome Measures

  1. Explore the representations of the disease in healthy siblings [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

  2. Evaluate their information and support needs following the announcement of the disease [1 year]

    information and support needs gathered during the semi-structured interview

  3. Identify the possible psychic and social consequences of the disease in these healthy subjects [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital Jeanne de Flandres, CHU Lille France

Sponsors and Collaborators

  • University Hospital, Lille

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT03541330
Other Study ID Numbers:
  • 2016_83
  • 2016-A02091-50
First Posted:
May 30, 2018
Last Update Posted:
Apr 22, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Lille

Study Results

No Results Posted as of Apr 22, 2021