- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Vandoeuvre les nancy, Frankrike
- CHRU de Nancy
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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)
|
Annen: 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)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Life quality of children according to satisfaction of school reintegration
Tidsramme: baseline
|
Evaluated through questionnaires
|
baseline
|
Life quality of children according to satisfaction of school reintegration
Tidsramme: 1 year
|
Evaluated through questionnaires
|
1 year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Anxiety
Tidsramme: baseline
|
Evaluated through questionnaires
|
baseline
|
Anxiety
Tidsramme: 1 year
|
Evaluated through questionnaires
|
1 year
|
Depressive symptoms
Tidsramme: baseline
|
Evaluated through questionnaires
|
baseline
|
Depressive symptoms
Tidsramme: 1 year
|
Evaluated through questionnaires
|
1 year
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Pascal Chastagner, Pr, Pediatric Hematology/Oncology, CHRU de Nancy
- Studiestol: Fabienne Lemétayer, University Paul Verlaine - Metz / Human Science and art department - Health psychology team
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 2009-A01379-48
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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