Cancer RemissionQdV leucémieNCT03240029
Life Quality of Children in Cancer Remission During School Reintegration
A study testing Questionnaires in people with Cancer Remission, run by Central Hospital, Nancy, France at 1 site in France.
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…). Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer Remission
- What is being tested?
- Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 7 Oct 2010to 11 Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
- Signed consent of parents
Who cannot join
- Psychic difficulties
- Specialized education
- Group of control children:
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Cancer Remission
- Being tested
- Questionnaires
- Keywords
- children, life quality, school reintegration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
SPP questionnaire (Self Perception Profile for Children), Systemic inventory of life quality for children (ISQV-E), Anxiety questionnaire (STAI-C), Depression questionnaire (CDI)
| Study group | Role | What they receive |
|---|---|---|
| Children in cancer remission | Experimental | Children in cancer remission sent to ordinary schools: primary (3rd, 4th, 5th grade) and middle (6th, 7th grade) schools. Receives: 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. Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life quality of children according to satisfaction of school reintegration
Evaluated through questionnaires
Measured: baseline
Life quality of children according to satisfaction of school reintegration
Evaluated through questionnaires
Measured: 1 year
Secondary outcomes (4)
Anxiety
Evaluated through questionnaires
Measured: baseline
Anxiety
Evaluated through questionnaires
Measured: 1 year
Depressive symptoms
Evaluated through questionnaires
Measured: baseline
Depressive symptoms
Evaluated through questionnaires
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study start7 Oct 2010
- Primary completion11 Sep 2013
- Study completion11 Sep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer RemissionStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal Chastagner, Pr, Principal investigator, Pediatric Hematology/Oncology, CHRU de NancyFabienne Lemétayer, Study chair, University Paul Verlaine - Metz / Human Science and art department - Health psychology team
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240029
- Sponsor's protocol ID
- 2009-A01379-48
- Acronym
- QdV leucémie
- Status last verified
- Aug 2017
- First submitted
- 2 Aug 2017
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Life Quality of Children in Cancer Remission During School Reintegration
- ClinicalTrials.gov ID
- NCT03240029
- Acronym / sponsor ID
- QdV leucémie / 2009-A01379-48
- Conditions
- Cancer Remission
- Keywords
- children, life quality, school reintegration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 7 Oct 2010 (actual)
- Primary completion
- 11 Sep 2013 (actual)
- Study completion
- 11 Sep 2013 (actual)
- First posted
- 4 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children in cancer remission | Experimental | Other: QuestionnairesChildren in cancer remission sent to ordinary schools: primary (3rd, 4th, 5th grade) and middle (6th, 7th grade) schools. |
| Control children | Other | Other: QuestionnairesChildren (not in cancer remission) sent to ordinary schools (age and sex matched): primary (3rd, 4th, 5th grade) and middle (6th, 7th grade) schools. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
- Signed consent of parents
Key exclusion criteria (3 listed)
- Psychic difficulties
- Specialized education
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesSPP questionnaire (Self Perception Profile for Children), Systemic inventory of life quality for children (ISQV-E), Anxiety questionnaire (STAI-C), Depression questionnaire (CDI) | Other | Children in cancer remission, Control children |
Primary outcome
Life quality of children according to satisfaction of school reintegration
Time frame: baseline
Evaluated through questionnaires
Life quality of children according to satisfaction of school reintegration
Time frame: 1 year
Evaluated through questionnaires
4 secondary outcomes
Anxiety
Time frame: baseline
Anxiety
Time frame: 1 year
Depressive symptoms
Time frame: baseline
Depressive symptoms
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires in people with Cancer Remission, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Life quality of children according to satisfaction of school reintegration (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2017.