NCT03240029

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 7, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2013

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2017

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

2.9 years

First QC Date

August 2, 2017

Last Update Submit

August 7, 2017

Conditions

Cancer Remission

Keywords

childrenlife qualityschool reintegration

Outcome Measures

Primary Outcomes (2)

  • Life quality of children according to satisfaction of school reintegration

    Evaluated through questionnaires

    baseline

  • Life quality of children according to satisfaction of school reintegration

    Evaluated through questionnaires

    1 year

Secondary Outcomes (4)

  • Anxiety

    baseline

  • Anxiety

    1 year

  • Depressive symptoms

    baseline

  • Depressive symptoms

    1 year

Study Arms (2)

Children in cancer remission

EXPERIMENTAL

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

Other: Questionnaires

Control children

OTHER

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

QuestionnairesOTHER

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

Children in cancer remissionControl children

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Psychic difficulties
  • Specialized education
  • Group of control children:
  • \- Signed consent of parents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nancy

Vandœuvre-lès-Nancy, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Pascal Chastagner, Pr

    Pediatric Hematology/Oncology, CHRU de Nancy

    PRINCIPAL INVESTIGATOR

  • Fabienne Lemétayer

    University Paul Verlaine - Metz / Human Science and art department - Health psychology team

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2017

First Posted

August 4, 2017

Study Start

October 7, 2010

Primary Completion

September 11, 2013

Study Completion

September 11, 2013

Last Updated

August 8, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)