CClinicalTrials.gg
CompletedNCT03240029QdV leucémieUpdated Aug 8, 2017

Life Quality of Children in Cancer Remission During School Reintegration

An interventional study of Questionnaires in Cancer Remission, sponsored by Central Hospital, Nancy, France. Completed at 1 site in France. Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-08.

Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 6 years 9 months after the study started (first participant enrolled Oct 2010, registered Aug 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
8 Years to 12 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cancer Remission

Keywords

  • children
  • life quality
  • school reintegration
03

In context

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Children in cancer remission

    Children in cancer remission sent to ordinary schools: primary (3rd, 4th, 5th grade) and middle (6th, 7th grade) schools.

    Other: Questionnaires

  • Other
    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.

    Other: Questionnaires

Interventions

  • OtherQuestionnaires

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

06

What researchers measure

Primary outcomes

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

    Evaluated through questionnaires

    Time frame: baseline

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

    Evaluated through questionnaires

    Time frame: 1 year

Secondary outcomes

  1. Anxiety

    Evaluated through questionnaires

    Time frame: baseline

  2. Anxiety

    Evaluated through questionnaires

    Time frame: 1 year

  3. Depressive symptoms

    Evaluated through questionnaires

    Time frame: baseline

  4. Depressive symptoms

    Evaluated through questionnaires

    Time frame: 1 year

07

Study locations

1 site
  • CHRU de Nancy
    Vandoeuvre les nancy, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03240029
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Sponsor
First posted
Aug 4, 2017
Start date
Oct 7, 2010
Primary completion
Sep 11, 2013
Completion
Sep 11, 2013
Last update
Aug 8, 2017

Study contacts

Pascal Chastagner, Pr
principal investigator · Pediatric Hematology/Oncology, CHRU de Nancy
Fabienne Lemétayer
study chair · University Paul Verlaine - Metz / Human Science and art department - Health psychology team

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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