Life Quality of Children in Cancer Remission During School Reintegration

Cancer Remission Clinical Trial

— QdV leucémie  

Official title:

Life Quality of Children in Cancer Remission During School Reintegration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03240029
• Other study ID #: 2009-A01379-48
• Status: Completed
• Phase: N/A
• First received: August 2, 2017
• Last updated: August 7, 2017
• Start date: October 7, 2010
• Est. completion date: September 11, 2013

Study information

• Verified date: August 2017
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 11, 2013
• Est. primary completion date: September 11, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer Remission

Intervention

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)

Locations

Country	Name	City	State
France	CHRU de Nancy	Vandoeuvre les nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Life quality of children according to satisfaction of school reintegration	Evaluated through questionnaires	baseline
Primary	Life quality of children according to satisfaction of school reintegration	Evaluated through questionnaires	1 year
Secondary	Anxiety	Evaluated through questionnaires	baseline
Secondary	Anxiety	Evaluated through questionnaires	1 year
Secondary	Depressive symptoms	Evaluated through questionnaires	baseline
Secondary	Depressive symptoms	Evaluated through questionnaires	1 year