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Completed

NCT Number: NCT03240029

Life Quality of Children in Cancer Remission During School Reintegration

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.

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Key information

Conditions

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Nancy

Vandœuvre-lès-Nancy, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

SPP questionnaire (Self Perception Profile for Children), Systemic inventory of life quality for children (ISQV-E), Anxiety questionnaire (STAI-C), Depression questionnaire (CDI)

Primary outcomes

  1. Life quality of children according to satisfaction of school reintegration

    Time frame: baseline

    Evaluated through questionnaires

  2. Life quality of children according to satisfaction of school reintegration

    Time frame: 1 year

    Evaluated through questionnaires

Secondary outcomes

  1. Anxiety

    Time frame: baseline

    Evaluated through questionnaires

  2. Anxiety

    Time frame: 1 year

    Evaluated through questionnaires

  3. Depressive symptoms

    Time frame: baseline

    Evaluated through questionnaires

  4. Depressive symptoms

    Time frame: 1 year

    Evaluated through questionnaires

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Acronym: QdV leucémie

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Aug 4, 2017
Registry last updated
Aug 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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