- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03240029
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.
Studieöversikt
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Vandoeuvre les nancy, Frankrike
- CHRU de Nancy
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Children in cancer remission
Children in cancer remission sent to ordinary schools: primary (3rd, 4th, 5th grade) and middle (6th, 7th grade) schools.
|
SPP questionnaire (Self Perception Profile for Children), Systemic inventory of life quality for children (ISQV-E), Anxiety questionnaire (STAI-C), Depression questionnaire (CDI)
|
Övrig: 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.
|
SPP questionnaire (Self Perception Profile for Children), Systemic inventory of life quality for children (ISQV-E), Anxiety questionnaire (STAI-C), Depression questionnaire (CDI)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Life quality of children according to satisfaction of school reintegration
Tidsram: baseline
|
Evaluated through questionnaires
|
baseline
|
Life quality of children according to satisfaction of school reintegration
Tidsram: 1 year
|
Evaluated through questionnaires
|
1 year
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Anxiety
Tidsram: baseline
|
Evaluated through questionnaires
|
baseline
|
Anxiety
Tidsram: 1 year
|
Evaluated through questionnaires
|
1 year
|
Depressive symptoms
Tidsram: baseline
|
Evaluated through questionnaires
|
baseline
|
Depressive symptoms
Tidsram: 1 year
|
Evaluated through questionnaires
|
1 year
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Pascal Chastagner, Pr, Pediatric Hematology/Oncology, CHRU de Nancy
- Studiestol: Fabienne Lemétayer, University Paul Verlaine - Metz / Human Science and art department - Health psychology team
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 2009-A01379-48
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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