Clinical trial · Observational
Observational Study Evaluating the Psychic Impact of the Diagnostic Announcement and Care for Children Treated for Cancer
NCT04244955CI-TRIAL-00054424IPSYLONterminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Investigator's decision
Summary
Brief summary (as posted)
The cancer diagnostic announcement and cancer care are both physical and psychological highlights. The main objective is to analyze significant psychological difficulties in children aged 6 to 16 treated for cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Semi-directive interviews | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Analyze of significant psychological difficulties in children aged 6 to 16
- timeFrame
- 30 minutes
- description
- Score at the Child Post-Traumatic Stress Reaction Index (CPTS-RI) questionnaire. A score strictly greater than 24 on the CPTS-RI questionnaire will be considered clinically significant for the primary endpoint
Secondary outcomes (3)
- measure
- Evaluation of the most disturbing elements for the child and the main clinical manifestations found.
- timeFrame
- 30 minutes
- description
- Most disturbing elements for the child (since the start of care and in invasive and / or repeated care) and the main clinical manifestations found during the semi-directive interviews, carried out by the child psychiatrist.
- measure
- Collection of the opinion of the caregivers (doctors, nurses) of each patient on the psychic impact of care on the child.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Patient aged 6 to 16 years; * Patient diagnosed for a malignant pathology for at least one month and maximum 2 months; * Patient treated at the IHOPe; * Non-opposition of the parents and the child under study. Exclusion Criteria: * Difficulty speaking and understanding French; * Patient who is not able to express himself because the somatic medical conditions do not allow a verbal exchange.
References
Publications (0)
Data not yet available
No reference posted for this study.