Clinical trial NCT03240029: Life Quality of Children in Cancer Remission During School Reintegration
Official title: Life Quality of Children in Cancer Remission During School Reintegration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Remission
Keywords: children
life quality
school reintegration
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-08-04
Enrollment: 100
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Life quality of children according to satisfaction of school reintegration
timeFrame: baseline
measure: Life quality of children according to satisfaction of school reintegration
timeFrame: 1 year
Secondary outcomes:
measure: Anxiety
timeFrame: baseline
measure: Anxiety
timeFrame: 1 year
measure: Depressive symptoms
timeFrame: baseline
measure: Depressive symptoms
timeFrame: 1 year
Other outcomes:
Locations:
city: Vandoeuvre les nancy
country: France
facility: CHRU de Nancy
Study officials:
affiliation: Pediatric Hematology/Oncology, CHRU de Nancy
name: Pascal Chastagner, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Paul Verlaine - Metz / Human Science and art department - Health psychology team
name: Fabienne Lemétayer
role: STUDY_CHAIR
References: