Life Quality of Children in Cancer Remission During School Reintegration (QdV leucémie)

Few data about the evaluation of consequences of past life with cancer on life quality of children in school reintegration are available in literature. Nevertheless, some of these studies show that the reintegration impairs life quality of these children (school difficulties, conflictual relations with peers…). The hypothesis is that children with past life with cancer have more chances to have school integration difficulties with a consequent life quality degradation compared to healthy children.

The main objective of this project is to study the relation between the satisfaction of school reintegration of children in cancer remission and the evolution of life quality in the medium term (after getting back to school). More exactly, it is the question if the satisfaction of school reintegration influences life goals and priorities of these children.

The secondary objective is to study the role of psychological status of these children (anxiety, depressive symptoms) on satisfaction-life quality relation.

A group of children with cancer history sent to ordinary school is compared to a control group of children sent to school in the same conditions (sex and age matched). Data are collected with questionnaires some months to several years after school reintegration and same questionnaires 1 year later.

If the study hypothesis is confirmed, this study will show the necessity of a long term follow up of children in cancer remission and not only medical care, but also psychological and social care, in order to support a better school reintegration.

Study Overview

• Status: Completed
• Conditions: Cancer Remission
• Intervention / Treatment: Other: Questionnaires

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Vandoeuvre les nancy, France
    • CHRU de NANCY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Group of children in cancer remission:

Inclusion Criteria:

• Children of both sexes in cancer remission (leukemia, with or without transplant and solid tumors), aged 8 to 12
• Stop of treatment since at least 6 months
• Back to school since some months to several years
• Signed consent of parents

Exclusion Criteria:

• Psychic difficulties
• Specialized education

Group of control children:

Inclusion Criteria:

- Signed consent of parents

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Children in cancer remission; Children in cancer remission sent to ordinary schools: primary (3rd, 4th, 5th grade) and middle (6th, 7th grade) schools.	Other: Questionnaires; SPP questionnaire (Self Perception Profile for Children), Systemic inventory of life quality for children (ISQV-E), Anxiety questionnaire (STAI-C), Depression questionnaire (CDI)
Other: Control children; Children (not in cancer remission) sent to ordinary schools (age and sex matched): primary (3rd, 4th, 5th grade) and middle (6th, 7th grade) schools.	Other: Questionnaires; SPP questionnaire (Self Perception Profile for Children), Systemic inventory of life quality for children (ISQV-E), Anxiety questionnaire (STAI-C), Depression questionnaire (CDI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Life quality of children according to satisfaction of school reintegration	Evaluated through questionnaires	baseline
Life quality of children according to satisfaction of school reintegration	Evaluated through questionnaires	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Evaluated through questionnaires	baseline
Anxiety	Evaluated through questionnaires	1 year
Depressive symptoms	Evaluated through questionnaires	baseline
Depressive symptoms	Evaluated through questionnaires	1 year

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Pascal Chastagner, Pr, Pediatric Hematology/Oncology, CHRU de Nancy; Study Chair: Fabienne Lemétayer, University Paul Verlaine - Metz / Human Science and art department - Health psychology team

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2010
• Primary Completion (Actual): September 11, 2013
• Study Completion (Actual): September 11, 2013

Study Registration Dates

• First Submitted: August 2, 2017
• First Submitted That Met QC Criteria: August 2, 2017
• First Posted (Actual): August 4, 2017

Study Record Updates

• Last Update Posted (Actual): August 8, 2017
• Last Update Submitted That Met QC Criteria: August 7, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: children; life quality; school reintegration
• Other Study ID Numbers: 2009-A01379-48

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